1.4 Um Sterility-Isolator-Vphp-generator v18413 r1 Eng

STERILITY ISOLATOR
+ VPHP GENERATOR
MODULAR ISOLATOR FOR

STERILITY TESTS
Use and maintenance manual

Translated copy of the original Italian text
UM_STERILITY-ISOLATOR+VPHP-GENERATOR_V18413_R1_ENG
Rev. Reason for revision Revision date

1 First edition 02/04/2019
Pag. 2/176
INDEX
1 GENERAL INFORMATION........................................................................................................................................................ 11
1.1 PURPOSE OF THE MANUAL.....................................................................................................................................................................12
1.1.1 GRAPHIC WARNING CONVENTIONS............................................................................................................................................12
1.2 RECOMMENDATIONS................................................................................................................................................................................13
1.2.1 OPERATORS FOR WHOM THIS MANUAL IS INTENDED.........................................................................................................13
1.3 WARRANTY AND EXCLUSION OF LIABILITY.....................................................................................................................................14
1.4 REQUESTING TECHNICAL ASSISTANCE..............................................................................................................................................14
1.5 MANUFACTURER AND MACHINE IDENTIFICATION DATA..........................................................................................................15
1.6 REFERENCE STANDARDS.........................................................................................................................................................................16
2 TECHNICAL SPECIFICATIONS................................................................................................................................................ 17
2.1 GENERAL INFORMATION.........................................................................................................................................................................17
2.1.1 MAIN GROUPS.......................................................................................................................................................................................18
2.2 OVERVIEW OF THE MAIN COMPONENTS..........................................................................................................................................20
2.2.1 FRONT VIEW...........................................................................................................................................................................................20
2.2.2 REAR VIEW..............................................................................................................................................................................................22
2.2.3 INTERNAL VIEW.....................................................................................................................................................................................24
2.3 OVERALL DIMENSIONS.............................................................................................................................................................................26
2.4 DESCRIPTION OF THE EQUIPMENT......................................................................................................................................................27
2.4.1 CONSTRUCTION FEATURES.............................................................................................................................................................27
2.4.1.1 STRUCTURE.................................................................................................................................................................................27
2.4.1.2 AIR TIGHT SYSTEM...................................................................................................................................................................27
2.4.2 VENTILATION.........................................................................................................................................................................................28
2.4.2.1 POSITION OF THE FILTERS....................................................................................................................................................28
2.4.2.2 VENTILATION SYSTEM DIAGRAM.......................................................................................................................................29
2.4.3 DECONTAMINATION...........................................................................................................................................................................30
2.4.3.1 DECONTAMINATION SYSTEM DIAGRAM........................................................................................................................30
2.4.3.2 VAPORIZED HYDROGEN PEROXIDE GENERATOR........................................................................................................31
2.4.4 QUALITY OF THE AIR...........................................................................................................................................................................32
2.4.4.1 MAIN CHAMBER........................................................................................................................................................................32
2.4.4.2 PRE-CHAMBER...........................................................................................................................................................................32
2.4.5 LIGHTING.................................................................................................................................................................................................33
2.4.6 ELECTRICAL AND PNEUMATIC PANELS LAYOUT.....................................................................................................................34
2.5 EQUIPMENT STRUCTURE.........................................................................................................................................................................35
2.5.1 PRE-CHAMBER.......................................................................................................................................................................................35
2.5.1.1 FRONT DOOR.............................................................................................................................................................................35
2.5.2 MAIN CHAMBER...................................................................................................................................................................................36
2.5.2.1 FRONT DOOR.............................................................................................................................................................................36
2.5.2.2 INTERNAL COMMUNICATION DOOR................................................................................................................................36
2.5.3 GLOVES....................................................................................................................................................................................................36
2.5.4 TECHNICAL COMPARTMENT FOR LIQUID WASTE EXTRACTION......................................................................................37
Pag. 3/176
2.6 ACCESSORIES................................................................................................................................................................................................38
2.6.1 EQUIPMENT LIST..................................................................................................................................................................................38
2.6.2 DESCRIPTION OF THE EQUIPMENT...............................................................................................................................................39
2.6.2.1 AIR FLOW SPEED PROBE .......................................................................................................................................................39
2.6.2.2 TEMPERATURE AND HUMIDITY SENSOR........................................................................................................................40
2.6.2.3 H2O2 LEVEL DETECTION SENSOR.....................................................................................................................................41
2.6.2.4 H2O2 LOW-CONCENTRATION DETECTION SENSOR (MINIMUM LEVEL)...........................................................42
2.6.2.5 GLOVE EXTENDER....................................................................................................................................................................42
2.6.2.6 INTERNAL SHELVES.................................................................................................................................................................42
2.6.2.7 PARTICLE COUNTER................................................................................................................................................................43
2.6.2.8 SET-UP FOR MICROBIOLOGICAL SAMPLER PROBE....................................................................................................43
2.6.2.9 ELECTRICAL SOCKETS............................................................................................................................................................44
2.6.2.10 AGT “ON BOARD” SYSTEM.....................................................................................................................................................45
2.7 TECHNICAL DATA........................................................................................................................................................................................46
2.7.1 REQUIRED SUPPLIES AND CONNECTIONS................................................................................................................................46
2.7.2 LEVEL OF NOISE GENERATED FROM THE EQUIPMENT.........................................................................................................47
2.8 AREA OF USE.................................................................................................................................................................................................48
3 SAFETY AND DAMAGE PREVENTION................................................................................................................................... 49

3.1 GENERAL STANDARDS..............................................................................................................................................................................49
3.2 HANDLING AND INSTALLATION REGULATIONS.............................................................................................................................49
3.3 OPERATION AND USE REGULATIONS.................................................................................................................................................49
3.4 ADJUSTMENTS AND MAINTENANCE REGULATIONS...................................................................................................................50
3.5 BEFORE OPERATING...................................................................................................................................................................................50
3.6 PICTOGRAMS................................................................................................................................................................................................51
3.6.1 SAFETY AND INFORMATION SIGNS..............................................................................................................................................51
3.6.2 POSITION OF SIGNS............................................................................................................................................................................52
3.7 RESIDUAL RISKS - OBLIGATIONS - PROHIBITIONS.........................................................................................................................53
3.7.1 ERGONOMIC DANGER.......................................................................................................................................................................53
3.7.2 DANGER FROM VPHP GENERATOR...............................................................................................................................................53
3.7.2.1 OPENING OF THE ISOLATOR DURING OR AT THE END OF THE DECONTAMINATION STAGE....................53
3.7.2.2 DANGERS RESULTING FROM ELECTRICAL SUPPLY LOSS DURING A DECONTAMINATION CYCLE.........54
3.7.2.3 DANGERS RESULTING FROM VPHP LEAKS.....................................................................................................................54
3.7.3 DANGER OF CONTACT WITH ELEMENTS IN TENSION...........................................................................................................55
3.7.4 EXTERNAL RISKS OR ABNORMAL CONDITIONS......................................................................................................................55
3.7.5 MANDATORY GLOVE USE.................................................................................................................................................................56
3.7.6 PROHIBITIONS.......................................................................................................................................................................................56
4 HANDLING AND INSTALLATION INSTRUCTIONS.............................................................................................................. 57

4.1 PACKAGING...................................................................................................................................................................................................57
4.2 TRANSPORT AND HANDLING THE PACKAGED EQUIPMENT.....................................................................................................58
4.3 STORAGE........................................................................................................................................................................................................59
4.4 DISPOSING OF THE PACKAGING...........................................................................................................................................................60
4.5 TRANSPORT AND HANDLING THE UNPACKAGED EQUIPMENT..............................................................................................60
Pag. 4/176
4.6 INSTALLATION..............................................................................................................................................................................................61
4.6.1 INSTALLATION CONDITIONS...........................................................................................................................................................61
4.6.2 INSTALLATION PROCEDURE - ROUTINE OPERATIONS..........................................................................................................62
4.6.3 CARRYING OUT INSTALLATION OPERATIONS..........................................................................................................................62
4.6.4 MEANS AND EQUIPMENT USED....................................................................................................................................................62
4.6.5 LEVELLING..............................................................................................................................................................................................63
4.6.6 INSTALLING THE FILTERS..................................................................................................................................................................63
4.7 MANAGING OUTGOING ENABLING SIGNALS FROM THE MACHINERY................................................................................64
4.8 CONNECTION TO THE ENERGY SOURCES.........................................................................................................................................64
4.8.1 POWER SUPPLY.....................................................................................................................................................................................64
4.8.2 PNEUMATIC POWER SUPPLY...........................................................................................................................................................64
5 PRECISION ADJUSTMENTS AND SET-UP............................................................................................................................ 65
6 OPERATING RULES................................................................................................................................................................... 67
6.1 OPERATOR POSITION................................................................................................................................................................................67
6.2 DESCRIPTION OF CONTROL PANELS, COMMANDS AND INDICATOR LIGHTS...................................................................68
6.2.1 OPERATOR PANEL................................................................................................................................................................................68
6.2.1.1 USER LEVELS...............................................................................................................................................................................69
6.2.2 DATA TRANSFER...................................................................................................................................................................................70
6.2.2.1 DATA TRANSFER MODE LAY-OUT......................................................................................................................................71
6.3 PRELIMINARY OPERATIONS....................................................................................................................................................................72
6.3.1 NORMAL START-UP.............................................................................................................................................................................72
6.4 NORMAL STOP.............................................................................................................................................................................................73
6.5 EMERGENCY STOP......................................................................................................................................................................................74
6.6 USING THE EQUIPMENT...........................................................................................................................................................................75
6.6.1 VENTILATION.........................................................................................................................................................................................75
6.6.2 LIGHTING.................................................................................................................................................................................................75
6.6.3 DECONTAMINATION...........................................................................................................................................................................75
6.6.4 OPENING/CLOSING DOORS.............................................................................................................................................................76
6.6.4.1 FRONT DOORS...........................................................................................................................................................................76
6.6.4.2 INTERNAL COMMUNICATION DOOR................................................................................................................................76
6.6.5 LIQUID WASTE COMPARTMENT.....................................................................................................................................................77
6.6.5.1 INSERTION AND CONNECTION OF LIQUID WASTE CONTAINERS........................................................................77
6.6.5.2 EXTRACTING LIQUID WASTE...............................................................................................................................................78
6.7 STATUS OF THE EQUIPMENT..................................................................................................................................................................79
6.7.1 LIGHT INDICATOR WITH BUZZER TO PRESS INTERNALLY...................................................................................................79
6.7.1.1 GREEN LIGHT..............................................................................................................................................................................79
6.7.1.2 YELLOW LIGHT..........................................................................................................................................................................79
6.7.1.3 RED LIGHT...................................................................................................................................................................................79
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7 MAINTENANCE.......................................................................................................................................................................... 81
7.1 WARNINGS REGARDING MAINTENANCE..........................................................................................................................................81
7.1.1 GENERAL INFORMATION..................................................................................................................................................................81
7.1.2 PRECAUTIONS AND SETTING THE MACHINE IN MAINTENANCE MODE.......................................................................82
7.2 ISOLATING THE MACHINE FROM ENERGY SOURCES...................................................................................................................83
7.2.1 ELECTRICAL SUPPLY SECTIONING................................................................................................................................................83
7.2.2 DISCONNECTING THE PNEUMATIC SUPPLY..............................................................................................................................84
7.2.3 LOCKING DEVICE FOR MAINTENANCE........................................................................................................................................85
7.2.4 DISSIPATION OF RESIDUAL ENERGIES.........................................................................................................................................86
7.2.5 VERIFICATION OF THE SAFE STATE (ISOLATION).....................................................................................................................86
7.2.6 RELEASE FROM LOCKOUT OR TAGOUT.......................................................................................................................................86
7.2.7 TEMPORARY REMOVAL OF THE LOCK-OUT DEVICES............................................................................................................86
7.2.8 INTERVENTIONS OVER SEVERAL WORK SHIFTS......................................................................................................................86
7.3 PERIODIC CHECKS......................................................................................................................................................................................87
7.3.1 EVERY DAY AND BEFORE STARTING THE PROCESSING CYCLE.........................................................................................87
7.3.2 WEEKLEY..................................................................................................................................................................................................87
7.3.3 EVERY MONTH......................................................................................................................................................................................88
7.3.4 EVERY THREE MONTHS......................................................................................................................................................................88
7.3.5 EVERY SIX MONTHS............................................................................................................................................................................89
7.3.6 EVERY 1000 HOURS OF OPERATION, AND IN ANY CASE, EVERY YEAR..........................................................................89
7.3.7 YEARLY OR AS INDICATED IN THE USER MANUALS OF THE INSTRUMENTS................................................................89
7.3.8 EVERY YEAR............................................................................................................................................................................................90
7.4 DESCRIPTIONS OF ADDITIONAL PERIODIC CONTROLS..............................................................................................................91
7.4.1 VERIFY THE CALIBRATION OF THE MEASURING SYSTEMS INSTALLED, AND CALIBRATE IF NECESSARY.........91
7.4.2 FILTER INTEGRITY TESTING - DOP TEST......................................................................................................................................91
7.4.3 VERIFICATION OF GLOVE TIGHTNESS VIA “ON BOARD” AGT..............................................................................................92
7.4.4 CHECK THE LIQUID LEVEL OF THE WATER SEPARATOR OF THE AIR HANDLING UNIT
OF THE PNEUMATIC BOARD............................................................................................................................................................94
7.5 COMECER REMOTE SUPPORT NETWORK ENABLING...................................................................................................................95
7.6 REPLACING THE FILTERS..........................................................................................................................................................................96
7.6.4.1 INLET FILTERS.............................................................................................................................................................................96
7.6.1 LAF FILTERS............................................................................................................................................................................................98
7.6.2 AIR INTAKE FILTERS...........................................................................................................................................................................102
7.7 REPLACING THE LAMPS..........................................................................................................................................................................104
7.8 CHANGING THE GAS SPRING...............................................................................................................................................................106
7.9 REPLACING THE GLOVES........................................................................................................................................................................108
7.10 REPLACING THE GLOVE FLANGES......................................................................................................................................................109
7.11 REPLACING THE INFLATABLE GASKETS...........................................................................................................................................110
7.12 CLEANING....................................................................................................................................................................................................113
7.12.1 RECOMMENDED PRODUCTS........................................................................................................................................................113
7.12.2 STAINLESS STEEL................................................................................................................................................................................114
7.12.3 PLASTIC MATERIAL............................................................................................................................................................................114
7.12.4 GLASS.....................................................................................................................................................................................................114
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8 DEMOLITION AND DISPOSAL.............................................................................................................................................. 115

8.1 GENERAL INSTRUCTIONS......................................................................................................................................................................115
8.2 DISPOSAL OF ELECTRIC AND ELECTRONIC EQUIPMENT.........................................................................................................115
9 ATTACHMENTS........................................................................................................................................................................ 117
10 ATTACHMENT: VPHP GENERATOR USE & MAINTENANCE MANUAL........................................................................... 119

10.1 GENERAL INFORMATION.......................................................................................................................................................................119
10.1.1 REFERENCE STANDARDS................................................................................................................................................................119
10.1.2 MANUFACTURER AND MACHINE IDENTIFICATION DATA.................................................................................................120
10.2 TECHNICAL SPECIFICATIONS...............................................................................................................................................................121
10.2.1 OVERVIEW.............................................................................................................................................................................................121
10.2.2 OVERVIEW OF THE MAIN COMPONENTS.................................................................................................................................122
10.2.3 KIT SUPPLIED WITH THE EQUIPMENT........................................................................................................................................128
10.2.4 OVERALL DIMENSIONS....................................................................................................................................................................129
10.2.5 DESCRIPTION OF THE EQUIPMENT.............................................................................................................................................130
10.2.5.1 CONSTRUCTION SPECIFICATIONS...................................................................................................................................130
10.2.6 EQUIPMENT STRUCTURE................................................................................................................................................................130
10.2.6.1 CATALYTIC CONVERTER.......................................................................................................................................................131
10.2.6.2 DEHUMIDIFIER........................................................................................................................................................................131
10.2.6.3 GENERATOR..............................................................................................................................................................................132
10.2.6.4 VENTILATION SYSTEM..........................................................................................................................................................132
10.2.6.5 DOSE AREA...............................................................................................................................................................................132
10.2.6.6 SAFETY SENSOR FOR H2O2 (HYDROGEN PEROXIDE SOLUTION)......................................................................133
10.2.7 OPTIONAL ACCESSORIES................................................................................................................................................................134
10.2.7.1 CHEMICAL AND BIOLOGICAL INDICATORS.................................................................................................................134
10.2.8 VPHP GENERATOR TECHNICAL DATA........................................................................................................................................134
10.2.8.1 REQUIRED SUPPLIES AND CONNECTIONS..................................................................................................................135
10.2.9 AREA OF USE........................................................................................................................................................................................135
10.3 SAFETY AND DAMAGE PREVENTION................................................................................................................................................136
10.3.1 PICTOGRAMS.......................................................................................................................................................................................136
10.3.1.1 SAFETY AND INFORMATION SIGNS................................................................................................................................136
10.3.1.2 POSITION OF SIGNS...............................................................................................................................................................137
10.3.2 RESIDUAL RISKS - OBLIGATIONS - PROHIBITIONS................................................................................................................138
10.3.2.1 ERGONOMIC DANGER..........................................................................................................................................................138
10.3.2.2 DANGER OF CORROSIONS OR CHEMICAL BURNS....................................................................................................138
10.3.2.3 DANGER OF BURNS...............................................................................................................................................................138
10.3.2.4 GAS LEAK HAZARD................................................................................................................................................................139
10.3.2.5 DANGERS RESULTING FROM THE USE OF CHEMICAL AGENTS...........................................................................140
10.3.2.6 RESIDUAL RISKS FOR HANDLING....................................................................................................................................140
10.3.2.7 RESIDUAL RISK OF TRIPPING.............................................................................................................................................140
10.3.2.8 MANDATORY USE OF PPE (PERSONAL PROTECTIVE EQUIPMENT)....................................................................141
10.3.2.9 MANDATORY SAFETY SHOES USE...................................................................................................................................141
10.3.2.10 PROHIBITIONS.........................................................................................................................................................................141
Pag. 7/176
10.4 HANDLING AND INSTALLATION INSTRUCTIONS.........................................................................................................................142

10.4.1 HOSE CONNECTIONS.......................................................................................................................................................................142
10.4.2 MANAGING INCOMING AND OUTGOING ENABLING SIGNALS TO THE EQUIPMENT.............................................143
10.4.3 CONNECTION TO THE ENERGY SOURCES................................................................................................................................143
10.4.3.1 POWER SUPPLY.......................................................................................................................................................................143
10.5 PRECISION ADJUSTMENTS AND SET-UP.........................................................................................................................................144
10.6 OPERATING STANDARDS.......................................................................................................................................................................144
10.6.1 OPERATOR POSITION.......................................................................................................................................................................144
10.6.2 DESCRIPTION OF CONTROL PANELS, COMMANDS AND INDICATOR LIGHTS..........................................................145
10.6.2.1 OPERATOR MAINTENANCE MANUAL - OPTIONAL...................................................................................................145
10.6.2.2 DATA TRANSFER......................................................................................................................................................................146
10.6.3 NORMAL START-UP...........................................................................................................................................................................147
10.6.4 NORMAL STOP....................................................................................................................................................................................148
10.6.5 EMERGENCY STOP.............................................................................................................................................................................149
10.6.6 USING THE EQUIPMENT..................................................................................................................................................................150
10.6.6.1 CONTAINER WITH HYDROGEN PEROXIDE SOLUTION.............................................................................................150
10.6.6.2 PUMP TRACT KIT ASSEMBLY..............................................................................................................................................150
10.6.6.3 DISPENSING PIPES KIT ASSEMBLY...................................................................................................................................151
10.6.6.4 DRÄGER SENSOR START-UP...............................................................................................................................................152
10.6.6.5 ACTIVATION OF DRÄGER SENSOR...................................................................................................................................153
10.6.6.6 SELECT CHAMBERS TO BE DECONTAMINATED..........................................................................................................154
10.6.6.7 STERILISATION START...........................................................................................................................................................154
10.6.7 OPERATIONAL FUNCTIONING......................................................................................................................................................155
10.6.8 GENERATOR STATUS.........................................................................................................................................................................156
10.7 MAINTENANCE...........................................................................................................................................................................................157
10.7.1 WARNINGS REGARDING MAINTENANCE.................................................................................................................................157
10.7.1.1 GENERAL INFORMATION.....................................................................................................................................................157
10.7.1.2 PRECAUTIONS AND SETTING THE MACHINE IN MAINTENANCE MODE..........................................................157
10.7.2 ISOLATING THE MACHINE FROM ENERGY SOURCES..........................................................................................................158
10.7.2.1 ELECTRICAL SUPPLY SECTIONING..................................................................................................................................158
10.7.2.2 LOCKING DEVICE FOR MAINTENANCE..........................................................................................................................159
10.7.2.3 DISSIPATION OF RESIDUAL ENERGIES...........................................................................................................................160
10.7.2.4 VERIFICATION OF THE SAFE STATE (ISOLATION).......................................................................................................160
10.7.2.5 RELEASE FROM LOCKOUT OR TAGOUT.........................................................................................................................160
10.7.2.6 TEMPORARY REMOVAL OF THE LOCK-OUT DEVICES..............................................................................................160
10.7.2.7 INTERVENTIONS OVER SEVERAL WORK SHIFTS.........................................................................................................160
10.7.3 PERIODIC CHECKS.............................................................................................................................................................................161
10.7.3.1 EVERY DAY AND BEFORE STARTING THE PROCESSING CYCLE............................................................................161
10.7.3.2 EVERY MONTH.........................................................................................................................................................................161
10.7.3.3 EVERY THREE MONTHS........................................................................................................................................................161
10.7.3.4 EVERY SIX MONTHS...............................................................................................................................................................161
10.7.3.5 EVERY 1000 HOURS OF OPERATION, AND IN ANY CASE, EVERY YEAR.............................................................162
10.7.3.6 YEARLY OR AS INDICATED IN THE USER MANUALS OF THE INSTRUMENTS..................................................162
10.7.3.7 EVERY YEAR...............................................................................................................................................................................162
10.7.3.8 EVERY TWO YEAR...................................................................................................................................................................162
10.7.3.9 EVERY FIVE YEARS..................................................................................................................................................................162
Pag. 8/176
10.7.4 DESCRIPTIONS OF ADDITIONAL PERIODIC CONTROLS.....................................................................................................163

10.7.4.1 FILTER INTEGRITY TESTING - DOP TEST.........................................................................................................................163
10.7.5 CALIBRATION OF PERISTALTIC PUMP........................................................................................................................................164
10.7.6 CALIBRATION OF THE DRAGER SENSOR...................................................................................................................................164
10.7.7 REPLACEMENT PROCEDURES.......................................................................................................................................................165
10.7.7.1 ABSOLUTE FILTER REPLACEMENT...................................................................................................................................165
10.7.7.2 REPLACEMENT OF THE H2O2 CONTAINER...................................................................................................................167
10.7.7.3 DISPENSING PIPES KIT REPLACEMENT..........................................................................................................................168
10.7.7.4 PUMP TRACT KIT REPLACEMENT.....................................................................................................................................170
10.7.7.5 LIQUID COLLECTION CONTAINER VERIFICATION AND EMPTYING....................................................................171
10.8 ATTACHMENTS...........................................................................................................................................................................................172
Pag. 9/176
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1 GENERAL INFORMATION
Read this manual and attachments carefully before performing any operation on the equipment
delivered to the final user.
INFORMATION
The following documents are an integral part of this manual:
· Operator Panel User Manual (attached separately).
· Specific manuals for the installed components (attached separately).
This manual is completed with additional documentation listed in chapter “ATTACHMENTS”.
All of the attached documentation is strictly required to use the product correctly and safely.
Pag. 11/176
1.1 PURPOSE OF THE MANUAL
This manual is an integral and essential part of the equipment.

COMECER supplies the Customer with this Use and Maintenance manual along with each machine, in order to provide the
operator with the necessary and essential directions concerning use and maintenance.
COMECER S.p.A.:
• Cannot be held liable for any damage caused by improper, incorrect and unreasonable use of the equipment.
• Is liable for equipment in its original configuration.
Any intervention that alters the structure or the functioning cycle of the equipment must be authorised by COMECER.
All instructions, drawings and data supplied in this manual are based on the latest information regarding our products
available at the time of printing. The photos and images provided are purely informative and illustrative. Consequently, some
images may not represent the specific equipment purchased by the customer.
No part of this manual may be reproduced, stored in retrieval systems, or transmitted in any form and by any means,
electronic, mechanical, photocopying, recording, without COMECER S.p.A’s prior written permission, except for the copies
made solely for internal use.
This manual was written with utmost attention in order to supply accurate and precise information. Nonetheless the authors
decline all implicit or explicit responsibility for errors present in the manual.
COMECER reserves the right to make changes at any time to improve the manual without forewarning and without incurring
any kind of obligations.
The information contained in the manual is addressed to professional personnel: experienced people with technical skills,
able to carry out the activities necessary to recognise and prevent possible dangers.
Constant compliance with the indications it states guarantees both machine and personnel safety, economic running and
longer working life.
To facilitate consultation, it has been divided into sections pointing out the most important principles. For a quick research
of the topics, it is recommended to consult the index of contents.
To better stress the importance of some basic passages, they have been highlighted in bold type and marked by symbols,
illustrated and defined below.
1.1.1 Graphic warning conventions
DANGER
Indicates the need to pay attention in order to prevent serious consequences resulting in death of
personnel or in hazard to health.
ATTENTION
Indicates a situation that could occur during the lifetime of a product, system or plant that has the
potential for human injury, damage to property, damage to environment, or economic loss.
CAUTION
Indicates the need to pay attention so as to prevent serious consequences that could lead to damage
to material items such as the assets or the product.
INFORMATION
Indicates important information.
Pag. 12/176
1.2 RECOMMENDATIONS
• The manual must be considered an integral part of the equipment and therefore must be kept for the duration of its
service life.
• The manual must be kept integral and legible in all parts.
• All operators using the equipment or responsible for its maintenance, must know the manual’s whereabouts, and have
the possibility to consult it at any time.
• All the personnel operating on the equipment in question should carefully read this manual.
• Do not to use the equipment unless all the essential parts of the manual are carefully read and understood.
• Do not remove, tear or rewrite parts of the manual for any reason.
• Keep the manual in a place protected from humidity and heat.
1.2.1 Operators for whom this manual is intended
OPERATORS and/or USERS: Qualified personnel authorised to operate on the equipment, carry out operations
on the control/command panel and visually check correct operation. They are not authorised to use the
equipment with the protections disabled.
MECHANICAL MAINTENANCE TECHNICIANS: Technicians trained and authorised to perform routine

maintenance (as defined in this manual) on mechanical and pneumatic parts. Specific qualification is required
for these operators.
ELECTRICAL MAINTENANCE TECHNICIANS: Technicians trained and authorised to perform routine maintenance
(as defined in this manual) on electrical and/or electronic parts. Specific qualification is required for these
operators.
QUALIFIED TECHNICIANS: Technicians authorised by COMECER to perform repairs and/or complex operations,
which are not provided in the aforesaid qualifications. In agreement with the User, they are provided by the
manufacturer for special eventualities. They are qualified for any type of intervention on the equipment.
ATTENTION
’’Qualified personnel’’ means people capable of operating and working on COMECER equipment
safely and effectively, with sufficient knowledge of the language in which this manual is supplied to
understand instructions, signs and commands featured in the manual and/or on the equipment itself
and/or inside the software.
Pag. 13/176
1.3 WARRANTY AND EXCLUSION OF LIABILITY
The complete terms of the warranty are contained in the contract of sale and are available at www.comecer.com under
“General Supply Conditions”.
The warranty is subject to the following conditions:
• The equipment must be used according to the limits declared in the contract and described in paragraph 2 “TECHNICAL
INFORMATION” in this manual.
• The equipment must be used according to the instructions contained in the manual.
• Maintenance operations must be performed with the frequency and in accordance with the modalities described in the
manual, using original spare parts only and by qualified personnel.
COMECER will accept no liability deriving from:
• Improper use.
• Used by unauthorised and/or untrained personnel.
• A failure to follow the instructions, either partially or completely.
• Power supply anomalies (electricity or compressed air).
• Lack of maintenance.
• Pollution from outside the equipment.
• Unauthorised modifications and repairs.
• Use of non-original and unauthorised spare parts.
• Exceptional events such as earthquakes or flooding, fires.
1.4 REQUESTING TECHNICAL ASSISTANCE
The assistance/after-sales service is always available for clarifications, interventions at the client’s premises with specialised
personnel and spare part orders.
Always specify:
• Client name and identification data.
• Equipment identification data such as: type, series number (job order); year of manufacture.
In case of need, contact:
COMECER S.p.A.
Via Maestri del Lavoro, 90 – 48014 Castel Bolognese (RA) Italy
http://www.comecer.com – email: service@comecer.com
tel. (+39) 0546 656375 – fax (+39) 0546 656353
INFORMATION
Please remember that the Client is obliged to purchase always original spare parts
(or equivalent authorized by COMECER in writing)
Pag. 14/176
1.5 MANUFACTURER AND MACHINE IDENTIFICATION DATA
The manufacturer’s and equipment’s identifying details are printed on a label:

A. Manufacturer identification.
B. CE compliance mark (where required).
C. Equipment model.
D. Type of equipment.
E. Equipment designation.
F. Serial number.
G. Electrical and/or pneumatic power.
H. Manufacturing year.
A
B
E D
H G
Pag. 15/176
1.6 REFERENCE STANDARDS
This product is manufactured in compliance with the following EU Directives:

• Directive 2006/42/EC on machinery, and amending Directive 95/16/EC (Machinery Directive)
• Directive 2014/30/EU relating to electromagnetic compatibility (EMC)
And, to the extent applicable, with the harmonized standards:
• EN ISO 12100:2010 Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO
12100:2010)
•• (following the ISO TR 14121-2:2012 - Safety of machinery - Risk assessment - Part 2: Practical guidance and examples
of methods)
• EN 60204-1:2006 Safety of machinery - Electrical equipment of machines - Part 1: General requirements (IEC 60204-
1:2005 (PEQ)
• EN 61000-6-2:2005 - Electromagnetic compatibility (EMC) Part 6-2: Generic standards - Immunity for industrial
environments (IEC 61000-6-2:2005)
• EN 61000-6-4:2007 - Electromagnetic compatibility (EMC) Part 6-4: Generic standards: Emission for industrial environments
(IEC 61000-6-4:2006)
And with the following standards and technical specifications:
• ISO 10648-1:1997 Containment enclosures - Part 1: Design principles
• ISO 10648-2:1994 Containment enclosures - Part 2: Classification according to leak tightness and associated checking
methods
• ISO 14644-1:2015 Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by
particle concentration
• ISO 14644-3:2005 Cleanrooms and associated controlled environments - Part 3: Test methods
• ISO 14644-7:2004 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods,
gloveboxes, isolators and mini-environments)
The product was designed in compliance with the following requirements:
• Eudralex - Volume 4 Good Manufacturing Practices (GMP) Guidelines.
Pag. 16/176
2 TECHNICAL SPECIFICATIONS
2.1 GENERAL INFORMATION
The modular isolator for sterility tests has been designed for laboratory professionals who require aseptic conditions while
testing the sterility of pharmaceutical products.
The isolator works in positive pressure with respect to the laboratory to ensure chambers sterility and product preservation.
The isolator comprises one or more chambers, as listed below:
• Pre-chamber - used for introducing the materials.
• Main chamber - used to perform the sterility test.
The isolator is equipped with a VPHP generator for the decontamination of the work areas.
One or more stools are supplied with the isolator to allow the operator to work sitting.
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2.1.1 Main groups
Ref. Description
Main chamber
Prechamber material insertion
Technical compartment
Technical compartment for liquid waste extraction
VPHP generator compartment
Pag. 18/176
2.2 OVERVIEW OF THE MAIN COMPONENTS
2.2.1 Front view
17 3
1 2
4
16 B
5
6
4
7
15
8
7
A C
14 13 12 11 10 9
A 20
19
18
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B C
24
21
25
23 26
22
Ref. Description Ref. Description

1 Light indicator with buzzer 14 Technical compartment - VPHP generator
2 Touch screen operator panel 15 Connections for data export
3 Fan for air extraction from the main chamber 16 Air inlet grille in the main chamber
4 Upper technical compartment
17 Fan for air extraction from the pre-chamber
5 Emergency stop button
18 Glove extender
6 General electrical disconnector
19 AGT on board flange system
7 LED lamp
20 AGT on board connection
8 Main chamber front door
21 Connections for DOP test
Technical compartment for liquid waste
9
extraction LAB PRESS REF fitting for laboratory pressure
22
10 Gloves flanges test
Electrical panel access panel (For further 23 Service air vent fitting and regulator (6 bar)
11 information, see the “Pneumatic and electrical
panels layout” chapter in this manual). 24 Air inlet for leak test
12 Pre chamber front door 25 Liquid waste disposal container
13 Lower technical compartment 26 Container movement trolley
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2.2.2 Rear view
10 11 12 13 14 15 16
20 21 20 19 18 17
1 D
D
8 1
3
6
4
7 6 5
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22
23
24

Temperature and humidity monitoring probe Automatic valve for air outlet from the pre-
1 13
transmitter chamber
H2O2 trend detection transmitter (maximum
2 Automatic valve for VPHP inlet in the pre-
level) 14
chamber
H2O2 low-concentration detection transmitter
3
(minimum level) 15 Manual valve for VPHP inlet in the pre-chamber
Three-way automatic valve for H2O2 (hydrogen
4 peroxide) inlet/outlet to the low-concentration 16 Automatic valve for air inlet in the pre-chamber
sensor
Secondart pneumatic panel (for more Automatic valve for VPHP outlet from the pre-
17
information see the “Layout of electrical and chamber
5
pneumatic boards” section of the present
manual) Manual valve for VPHP outlet for the pre-
18
chamber
Three-way automatic valve for VPHP
6
recirculation
Automatic valve for VPHP outlet from the main
19
7 Particle counter chamber
8 VPHP recirculation pump compartement

20 Manual valve for VPHP inlet in the main chamber
9 Pre-chamber air inlet grill
Automatic valve for VPHP inlet in the main
Automatic valve for air outlet from the main 21
10 chamber
chamber
Pneumatic line arrival air handling unit (For 22 Laminar air flow filter
further information, please refer to chapter
11
’’Electrical and pneumatic panel layout’’ in this 23 Laminar flow plenum air
manual)
12 Automatic valve for air inlet in the main chamber 24 Fan for laminar air flow
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2.2.3 Internal view
1 2 3 4 2 5 6 4 2 7
8 7 8 12 11 10 9 8
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15 2
14
7
13
Ref. Description
1 Internal communication door
2 Airflow diffuser
3 Bar with hooks
4 VPHP main chamber inlet
5 Air flow speed monitoring probe
6 Temperature and humidity monitoring probe
7 Shelves
8 Air recirculation deflector
9 Liquid waste discharge duct
10 Sterility test pump (not supplied by Comecer)
11 Particle counter probe
12 Set-up for connection with microbiological impactor
13 Sliding tray
14 VPHP pre-chamber inlet
15 Detection transmitter for H2O2 (hydrogen peroxide solution)
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2.3 OVERALL DIMENSIONS
3780
2700
1380
3880
INFORMATION
For further information on the dimensions, please refer to the attached documentation.
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2.4 DESCRIPTION OF THE EQUIPMENT
2.4.1 Construction features
2.4.1.1 Structure
Supporting frame
Support frame made of tubular AISI steel with outer Scotch-BriteTM surface finishing. The joints are welded with TIG welding
in an argon gas atmosphere; the weld seams are ground and smoothened.
The structure comes complete with self-levelling feet.
Work area
The work chamber is made from a single block of AISI 316L stainless steel, with Mirror-Bright internal surface finish, TIG
continuous welds, then ground and smoothed and widely rounded corners. These characteristics ensure maximum ease
and effectiveness of the decontamination procedures and prevent the infiltration and accumulation of contaminants in the
joints.
Coverings
All external coverings are realised completely in AISI 304 stainless steel with Scotch-Brite TM finishing.
2.4.1.2 Air tight system
An inflatable gasket system, along the perimeter of the openings, guarantees

chamber closure and quick, safe and easy movement of the panels, with no
mechanical locking systems. The control system guarantees air tightness and
maintains the position of the panels even if there is no electric and pneumatic
supply, while allowing the emergency opening via a manual valve being
activated.
All inflatable gaskets of the doors are made of Bio-Guardian® silicone.
Pag. 27/176
2.4.2 Ventilation
2.4.2.1 Position of the filters
INFORMATION
The position of the external components of the ventilation system is indicative and may vary based on
the installation layout to improve access for maintenance.
1
6
2
5
3
4
Ref. Description Function

1 F7 pre-filter Prechamber air inlet filtering
2 U15 absolute filter Main chamber unidirectional/laminar air flow filtering
3 U15 absolute filter Main chamber air filtering in return
4 U15 absolute filter Pre-chamber return air filtering
5 U15 absolute filter Pre-chamber unidirectional/laminar air flow filtering
6 F7 pre-filter Main chamber air ingress filter
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2.4.2.2 Ventilation system diagram
A B
Ref. Description
Inlet flow
Outlet flow
Absolute Filter
Automatic Valve
Fan
A Prechamber
B Main chamber
Pag. 29/176
2.4.3 Decontamination
Decontamination can be actuated in different ways:

• Complete decontamination of the isolator with communication doors open.
• Pre-chamber decontamination.
2.4.3.1 Decontamination system diagram
G
VPHP
A B
2 C 2 D
3 3
Pag. 30/176
Detection sensor for main chamber H2O2 minimum level. The sensor can work in two different conditions:
IA IA
AE AE
UA UA
During the aeration phase (concentration of H2O2 within the

During the decontamination phase (concentration of H2O2 within
chamber < 50 ppm) and during the other states of isolator functio-
the chamber > 50 ppm) air is drawn from the laboratory
ning, the Drager sensor reads the H2O2 level within the chamber
1 Liquid waste container

Decontaminable areas
2 VPHP outlet from the isolator to the generator
VPHP inlet system
2 Air outlet towards laboratory
VPHP recirculation system 3 VPHP outlet to air recirculation main chamber
VPHP extraction system A Prechamber
B Main chamber
Automatic Valve
C Particle-counter
Manual ball valve D Microbiological impactor setup
GVPHP VPHP generator
Three-way automatic valve H2O2 low-concentration detection sensor

AE
(minimum level)
IA Air inlet from laboratory

Pump
UA Air outlet towards laboratory
2.4.3.2 Vaporized hydrogen peroxide generator
INFORMATION
For more information, consult the relevant documentation, supplied as a an attachment.
Pag. 31/176
2.4.4 Quality of the air
2.4.4.1 Main chamber
The particle content in the air complies with the ISO 14644-1 and EEC-cGMP requisites.
For grade A “At rest” (EEC-cGMP):
• Class ISO 5 (ISO 14644-1): ≤ 3520 part./m3 for particles Ø ≥ 0.5 µm
• Class ISO 4.8 (ISO 14644-1): ≤ 20 part./m3 for particles Ø ≥ 5.0 µm
The speed of the flow corresponds with the features required for critical areas (Grade A) in accordance with the EEC-cGMP
Directive: 0.45 m/sec ± 20%.
2.4.4.2 Pre-chamber
The particle content in the air complies with the ISO 14644-1 and EEC-cGMP requisites.
For grade A “At rest” (EEC-cGMP):
• Class ISO 5 (ISO 14644-1): ≤ 3520 part./m3 for particles Ø ≥ 0.5 µm
• Class ISO 4.8 (ISO 14644-1): ≤ 20 part./m3 for particles Ø ≥ 5.0 µm
The speed of the flow corresponds with the features required for critical areas (Grade A) in accordance with the EEC-cGMP
Directive: 0.45 m/sec ± 20%.
Pag. 32/176
2.4.5 Lighting
The equipment has one or more low-consumption LED lamps for illuminating the entire work area.
Ref. Description Function
LED Lamp Main chamber lighting
LED Lamp Pre-chamber lighting
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2.4.6 Electrical and pneumatic panels layout
Ref. Description
Electronic control panel
Pneumatic line arrival air handling unit
Secondary pneumatic panel
Return to general electric control panel box
INFORMATION
Refer to the attached wiring diagram for information on the positions of the junction boxes (JBs)
connected to the electrical cabins.
Pag. 34/176
2.5 EQUIPMENT STRUCTURE
2.5.1 Pre-chamber
The pre-chamber allows materials to pass towards or from the main chamber while keeping the pre-established pressure
values unchanged.
There is a glazed front door on the outside of the pre-chamber.
The pre-chamber is equipped with inflatable gaskets that ensure airtight sealing.
Some doors could be equipped with interlock to prevent them from being opened simultaneously and to guarantee the
safety of the processes.
This condition ensures sterility in the various work environments.
2.5.1.1 Front door
The door is made with 13 mm-thick tempered glass and is hinged at the top.
The doors are fitted with gas springs to facilitate the opening and to maintain
the door lifted up when open
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2.5.2 Main chamber
The main chamber allows for materials processing.

There is a front door on the outside of the main chamber, provided with one or two gloves
Inside there is a glass door to allow for the transfer of materials to or from the pre-chamber.
The main chamber is equipped with inflatable gaskets that ensure airtight sealing.
Some doors could be equipped with interlock to prevent them from being opened simultaneously and to guarantee the
safety of the processes.
This condition allows sterility to be ensured in the various work environments.
2.5.2.1 Front door
The door is made with 13 mm-thick stratified tempered glass and is hinged at
the top.
The door is equipped with flanges for glove assembly and gas springs to
facilitate and maintain door opening.
2.5.2.2 Internal communication door
The internal communication door is made with 12 mm-thick tempered glass

and is laterally hinged.
2.5.3 Gloves
The equipment is provided with CSM gloves with polypropylene flange.
ATTENTION
When extracting your hands from the gloves, pay attention not to remove the gloves from the groove
of the flange.
Before proceeding, verify that the gloves are in good condition and have no cuts or incisions and make
sure they are in the correct position on the respective grooves.
Insert your hands into the gloves free from any item that could slit them (rings, watches, bracelets,
etc.)
If they are damaged, you will need to replace them, as described in the chapter on “Gloves replacement”.
Pag. 36/176
2.5.4 Technical compartment for liquid waste extraction
The equipment is equipped with a duct to discharge liquid waste and conveys
i tinto a closed cointainer.
The 20L container is housed in a dedicated compartment on a wheel trolley.
CAUTION
The equipment is not fitted with sensors and indicators that detect and report the fill status of the
liquid waste container.
Therefore, the operator must visually check the fill status of the container and dispose of the waste
when necessary, to prevent it from overflowing.
CAUTION
Do not dispose of pollutants into the environment. Dispose of the materials in compliance with the
relevant regulations in force.
Pag. 37/176
2.6 ACCESSORIES
2.6.1 Equipment list
• Air flow speed probe

• Temperature and humidity sensor
• H2O2 level detection sensor
• H2O2 low-concentration detection sensor (minimum level)
• Glove extender
• Internal shelves
• Particle counter
• Set-up for microbiological sampler probe
• Electrical sockets
• AGT “on board” system
Pag. 38/176
2.6.2 Description of the equipment
INFORMATION
For more information on accessories, please refer to the relevant documentation provided in the
annex.
2.6.2.1 Air flow speed probe
SCHMIDT model SS 20.400
The equipment is provided with one or more air flow speed measuring sensors.
Parameter Value / function
Measuring quantity Normal velocity Wn of air based on normal conditions 20 °C and 1013.25 hPa
Medium to be measured Clean air or nitrogen; more gases on request
Measuring range 0 ... 1 / 2.5 / 5 / 10 / 20 m/s (unidirectional or bi-directional)
Lower detection limit 0.05 m/s
Measuring accuracy ± (3 % of measured value +0.4 % of final value); min. ± 0.05 m/s
Repeatability ± 2 % of measured value
Response time t90 0.01 ... 10 s (configurable)
Storage temperature -20 ... +85 °C
Operating temperature 0 ... +60 °C
Humidity range 0 ... 95 % rel. humidity (RH)
Operating pressure 700 ... 1300 hPa
INFORMATION
The anemometer measurements may be inconsistent if objects (for example bags) are placed near the
sampling point. To prevent inconsistent measurements and system faults, do not place objects within
a hypothetical sphere of radius of 10 cm built around the sensitive region of the anemometer.
Pag. 39/176
2.6.2.2 Temperature and humidity sensor
DRIESEN KERN model DKRF473
The equipment is provided with one or more temperature and humidity sensors.
The main characteristics: of the sensor are:
· Based on COMSens technology
· The transducers are resistant to dust and most chemical products.
· High precision ±1.8 % UR
· Hydrogen peroxide resistant
Humidity
Sensirion CMOSens capacitive
Type of sensor
sensitive element
Humidity range in % 0..100%
Humidity precision in % +/- 1.8% (20...80%)
4 seconds without filter
Response time (63%)
15 seconds with filter
Temperature
Type of sensor CMOSens-Structure
Temperature range °C -40... +80
Accuracy °C 0.3 at 25
Response time appr. 35 seconds
Pag. 40/176
2.6.2.3 H2O2 level detection sensor
ATI model H10
The equipment is fitted with one or more ATI H10 electrochemical sensors
with an F12 2-wire transmitter to detect the minimum and maximum level of
hydrogen peroxide solution in the isolator.
The minimum level reading range is 0-200 PPM, whereas the maximum level
reading range is 0-2000 PPM.
The sensor is connected to the isolator PLC and is used to control the trend of
the H2O2 (PPM) level during the entire sterilisation cycle.
Minimum range ppm 0-200

Maximum range ppm 0-2000
Precision in % 10%
Electronic repeatability in % 1%
Electronic linearity in % 0.5%
Electric voltage VDC 12-28
Weight Kg 0.45
Operating temperature range °C Da -30 a 60
Operating humidity range in % 10-95% (non-condensing)
Output current intensity range mA 4-20
ATTENTION
In case of inconsistent reading of the expected values, check the connection of the sensor to the
transmitter.
ATTENTION
Every time the equipment is started, the ATI detection sensor requires about 4 hours to heat up, before
which it is not possible to do sampling.
Start the equipment earlier so the sensor can be operative before starting a sterilisation cycle with the
VPHP.
INFORMATION
The only purpose of this sensor is to indicate the trend of H2O2. It CANNOT be used as a safety sensor.
INFORMATION
For further details on the sensor management, refer to the documentation attached.
Pag. 41/176
2.6.2.4 H2O2 low-concentration detection sensor (minimum level)
The equipment is provided with one or more Dräger Polytron 7000 detectors
with electrochemical sensor to detect the level of hydrogen peroxide in the
area to be decontaminated.
Minimum detectable value: 0.1ppm.
The sensor is connected to the equipment PLC and is used to guide and
complete the sterilisation cycle.
The aeration cycle is only completed when the level of H2O2 has gone down
to 1 ppm.
2.6.2.5 Glove extender
The system is installed on isolator gloves during the decontamination process

with VPHP (Vapor Phase Hydrogen Peroxide).
The glove is supported by a “hand” with fingers. The fingers of the support are
spaced so as to open the gloves during the sanitising process.
2.6.2.6 Internal shelves
The equipment is equipped with one or more shelves positioned on the bottom
of the working chamber.
ATTENTION
Maximum capacity: 5 Kg
Pag. 42/176
2.6.2.7 Particle counter
Model IsoAir 310P of the Particle Measuring System
The equipment is equipped with one or more particle-counters to monitor

particle contamination in the air.
The counter is equipped with a steel case that makes it suitable for use in sterile
environments.
The internal pump with discharge equipped with HEPA filter provides protection
against the creation of further particles.
Case material Stainless steel

Operating temp. 4-35 °C
Relative humidity in % 5-95% without condensation
Sample flow rate 28.3 l/min (1 CFM)
2.6.2.8 Set-up for microbiological sampler probe
The machine has one or more set-ups to connect for connection of the
microbiological sampler probes.
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2.6.2.9 Electrical sockets
The machine is equipped with one or more electrical outlets with external
command that can be activated by pressing the corresponding buttons or from
the operator panel.
INFORMATION
The use limits of the internal sockets are linked to the overall power available on the machine.
See the wiring diagram for data relative to power absorbed by the machine and the resulting power
available for the sockets.
Pag. 44/176
2.6.2.10 AGT “on board” system
Automatic on-board glove integrity testing system for testing the integrity of
gloves.
Pneumatic application and removal of the flange using the ON/OFF button
positioned above the flange.
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2.7 TECHNICAL DATA
Frame structure: AISI 304

Stainless steel sheet
Chambers: AISI 316L
External: Scotch-Brite
Finishing
Internal: Mirror - Brite
Electric control board protection rating IP 54
Internal dimensions See the ’’OVERALL DIMENSIONS’’ section
External dimensions See the ’’OVERALL DIMENSIONS’’ section
Weight kg ~2050
Maximum current absorption A 18
2.7.1 Required supplies and connections
For Europe
Main power supply 230V (1Ph+N+PE) | 50/60Hz | 32A TN-S
& similar
Minimum pneumatic supply 25 nL/min | 6 bar | 1/2”G female
Compressed air quality Class 1.4.1 or higher (ISO 8573-1)
CAUTION
The final user must ensure the following:
· all the supplies of power/energy must be stable and compliant with values defined in the present
manual;
· the electrical supplies must be provided within the ranges defined by the applicable standards (as
example, par. 4.3 of EN 60204-1 (IEC 60204-1) and NFPA 79);
· cycles of switch-off and switch-on of short duration and/or repeated at short intervals must be
avoided;
Failure to observe the specifications above may cause malfunctions and damages.
Pag. 46/176
2.7.2 Level of noise generated from the equipment
The values of airborne noise emissions were determined by measures performed:

1) For the machinery in question or for technically comparable machinery which is representative;
2) Using measuring methods UNI EN ISO 11202 and UNI EN ISO 3746 with suitable instruments;
3) At manufacturer Comecer facility (industrial environment reflecting K2A<7);
4) Considering the different operating conditions.
The A-weighted emission sound pressure level (LpA / SPL) at workstations does not exceed 70 dB(A).
Measures are measured at a distance of 1 m from the surface of the machinery and at a height of 1,6 m from the floor, or at
workstations if they are at a distance less than 1 m.
The peak C-weighted instantaneous sound pressure value at workstations does not exceed 63 Pa (130 dB in relation to20
microPa).
Site final customer (as employer) is responsible for the risk assessment of the exposure of workers to noise following site
applicable national standards (see also Directive 2003/10/EC).
As part of above employer assessment, it is recommended that measures of sound pressure levels are performed on site at
workstation by customer.
The exposure of workers to noise depends on factors which cannot be determined or controlled by Comecer, such as:
• Characteristics of workplace (i.e. room walls for separation of process laboratory (clean-room) and further adjacent
technical areas, room false ceilings or others), with related noise absorption, scattering and reflection;
• Noise emissions from other sources (such as, for example, room ventilation or further equipment);
• Conditions of use of the machinery.
Employer shall also define noise exposure levels of workers (exposure time weighted average LEX). Those values depend on
actual cycles times (such as production schedule, cleaning, etc) and actual presence of workers (actual positions, work shifts,
etc.)
Following the noise exposure risk assessment the employer shall define, as applicable, suitable actions in order to reduce
exposure levels, for example:
• The use of PPE (Personal Protective Equipment);
• Restricted access control to technical areas (access is determined by customer site operating procedures).
Pag. 47/176
2.8 AREA OF USE
The equipment is designed in order to be used within a pharmaceutical environment or similar. This means it is assumed
the equipment is protected from open air weather conditions and is used within enclosed rooms such as laboratories or
technical areas, with appropriate management of cleanness and the environmental parameters.
It is assumed that no liquid or dusty contaminants are present in the environment, for example suspended powdres, mists,
aerosols and similar.
The equipment is designed to be used between ambient air temperatures of 10°C and 30°C and relative humidity between
30% and 70% (noncondensing).
The maximum design altitude is 1000 m above sea level.
The equipment must be used in an ambient with suitable light conditions to ensure health and safety for operators, both in
normal use and during maintenance, considering light levels, light sources position and orientation, glares or other.
The equipment is not designed to be used in areas with significant vibration, shock and bump.
The equipment is not designed to be used in areas with potentially explosive and/or flammable atmospheres.
Pag. 48/176
3 SAFETY AND DAMAGE PREVENTION
3.1 GENERAL STANDARDS
During the design and construction phase, the manufacturer paid particular attention to the aspects that can cause risks
to the health and safety of people interacting with the equipment. Apart from complying with the relevant laws in force, all
the “regulations of proper manufacturing technique” have been followed. The purpose of this information is for users to be
aware and pay particular attention in order to prevent any risk. Caution is, however, irreplaceable. Safety is also in the hands
of all operators interacting with the equipment.
Carefully read the instructions given in the manual supplied and those applied directly, in particular, comply with those
concerning safety.
Pay attention to the meaning of the symbols on the attached plates; their shape and colour are relevant in terms of safety.
Keep them legible and comply with the information shown.
Do not tamper with, elude, eliminate or bypass the installed safety devices. Failure to comply with this requirement can lead
to serious risks to personal health and safety.
Personnel carrying out any kind of intervention, throughout the equipment’s life-cycle, must have the technical skill, specific
ability and acquired and acknowledged experience in that specific sector. The lack of these requirements can pose a risk to
personal health and safety.
3.2 HANDLING AND INSTALLATION REGULATIONS
Carry out lifting and handling in compliance with the information supplied by the manufacturer and shown directly on the
packing, the equipment and the user instructions.
Personnel who load, unload and handle the equipment must have the capability and experience acquired and acknowledged
in that specific sector and must have know-how regarding the lifting means to be used.
Loading and transport must be carried out using means of a suitable capacity by the anchorage of the equipment in the
points defined by the manufacturer. Whoever is authorised to carry out these operations must have specific ability and
experience in order to safeguard their own safety and that of others involved.
Before the equipment and its components are transferred onto the means of transport, make sure that they are appropriately
fixed to the means and that their clearance does not surpass the maximum foreseen overall sizes. If necessary, set up the
appropriate signs.
3.3 OPERATION AND USE REGULATIONS
The operator, other than being suitably documented on the use of the equipment, must be in possession of adequate skills
and competence for the type of working activity to be carried out.
If necessary, even after being appropriately instructed, when using the machine for the first time, simulate a few test
manoeuvres to identify the controls and their main functions, especially those to start and stop the machine.
Only use the equipment for the uses that the manufacturer intended.
The improper use of equipment can create risks for the health and safety of people and cause economic damage.
The equipment has been designed and constructed to satisfy all of the operating conditions indicated by the manufacturer.
The interference with any device to obtain performances different to those for which it is designed can create risks for the
health and safety of people and cause economic damage.
Do not use the equipment if the safety devices are not perfectly and efficiently installed. The non-compliance of this
requirement can cause serious risks for the health and safety of people.
Do not use the equipment on uneven or inclined surfaces.
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3.4 ADJUSTMENTS AND MAINTENANCE REGULATIONS
Always keep the equipment fully efficient and carry out programmed maintenance as scheduled by the manufacturer. Good
maintenance will ensure the best machine performance, a longer life and cycle and constant fulfilment of safety requirements.
Maintenance and adjustments must be carried out by authorised personnel who must prepare all the necessary safety
conditions and abide by the procedures as shown.
All maintenance operations requiring specific technical skills or special ability must only be carried out by qualified personnel
with acknowledged and acquired experience in the specific field of intervention.
Replace parts that are too worn with original spare parts. Use the oils and lubricants recommended by the manufacturer. All
this will ensure the functionality and the safety level of the system.
Do not dispose of pollutants into the environment. Dispose of the materials in compliance with the relevant regulations in
force.
3.5 BEFORE OPERATING
Please read this manual carefully before performing any operation on the equipment.
Before operating or performing maintenance, the operator must:

• Have carefully read and understood this manual;
• Know the provisions about personal safety, in particular complying with the standards in force concerning safety in the
workplace.
• Know the substances, how to process them and what danger and damage they might cause.
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3.6 PICTOGRAMS
3.6.1 Safety and information signs
The signs shown in this paragraph are affixed to the equipment; their position is described in the paragraph “Position of the
signs”:
Equipment identification plate.
Danger - High voltage
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3.6.2 Position of signs
Make sure that the signs are legible; otherwise, clean them or replace them, setting them in their original place.
Pag. 52/176
3.7 RESIDUAL RISKS - OBLIGATIONS - PROHIBITIONS
3.7.1 Ergonomic danger
During use of the equipment, the operator can be exposed to risks relating to ergonomics, such as: overloading or
incongruous positions.
It is recommended to carry out ergonomic risk assessments relating to the actual work tasks carried out by the operator
using the COMECER equipment.
DANGER
Danger of overloading upper limbs and/or muscular skeletal disorders.
Before using the equipment, carry out ergonomic risk assessments.
Work and/or posture procedures different from those detailed by COMECER may increase risk factors.
3.7.2 Danger from VPHP generator
During equipment use, the operator may be exposed to risks deriving from the VPHP generator (example: hydrogen peroxide
leaks into the environment).
ATTENTION
The operator must press the emergency button only to safely stop the VPHP generator in the event of
an emergency.
INFORMATION
For further information, see the attached VPHP generator user and maintenance manual.
3.7.2.1 Opening of the isolator during or at the end of the decontamination stage
During and at the end of the decontamination cycle, a functional interlock prevents the inflatable seals of the isolator’s
external doors from deflating, to prevent exposing the operator to the hydrogen peroxide and to preserve the process.
ATTENTION
Do not force opening the doors in order not to impair the isolator’s seal.
If installed, the low concentration sensor on the ventilation branches should not be considered a safety sensor to enable
opening of the doors.
The Customer must arrange for SOPs to establish the time and manner of chamber access after they have been sterilised.
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3.7.2.2 Dangers resulting from electrical supply loss during a decontamination cycle
If an electrical black-out occurs during a decontamination cycle and in absence of UPS, significant concentrations of hydrogen
peroxide can remain trapped into the isolator and into ventilation pipes.
In these conditions the operator must proceed according to operative procedures (SOP), so:
• Only trained personnel has to stay in the laboratory;
• Do not force the isolator doors for their opening;
• If possible, laboratory must be ventilated, also by means of natural ventilation
• When the electrical supply returns, a completed aeration cycle of the chambers must be executed in order to eliminate
residuals of hydrogen peroxide vapor
3.7.2.3 Dangers resulting from VPHP leaks
The machinery and/or the generator can be equipped with a sensor for detecting any VPHP leaks in the surrounding areas.
DANGER
The sensors installed are not devices able to guarantee the safety function in the event of VPHP
(Vapour Phase Hydrogen Peroxide) leaks inside the entire laboratory.
ATTENTION
If one of the sensors installed by COMECER detects VPHP (Vapor Phase Hydrogen Peroxide) leaks, the
equipment will automatically activate the air extraction cycle.
ATTENTION
In case of VPHP (Vapor Phase Hydrogen Peroxide) leaks signalled by one of the sensors, proceed
according to that established by the customer’s SOP (Standard operative procedure) for the reduction
of the risk.
In addition to the sensors supplied with the equipment and/or generator, the final user is authorised to install further sensors
inside the laboratory to enhance safety and to prevent the dangers caused by leakage of VPHP (Vapor Phase Hydrogen
Peroxide).
To install the aforesaid additional sensors, please refer to the qualified expert for an assessment of the most suitable position.
INFORMATION
The installation of other safety sensors for H2O2 in the laboratory is the customer’s responsibility.
ATTENTION
In case of VPHP (Vapor Phase Hydrogen Peroxide) leaks signalled by the laboratory sensors installed
by the customer, immediately stop the generator by pressing the emergency button and proceed
of the risk.
INFORMATION
For further information on the VPHP generator, refer to the attached user and maintenance manual.
Pag. 54/176
3.7.3 Danger of contact with elements in tension
DANGER
The electric panel must only be accessed by qualified technicians after having disconnected all the
components.
3.7.4 External risks or abnormal conditions
User has to perform a general risk analysis that includes all processes and equipment that are in site.
Further risks or abnormal conditions derived from environment (building) or further equipment must be defined in a
documented manner to Comecer, where these conditions can have impact to the design of equipment supplied by Comecer
Examples of possible risks may be (but not limited to):
A. Flooding
B. Structural limits of premises (capacities, heights, etc)
C. Over-pressure on pipes or adjacent pressure vessels
D. High temperature of adjacent equipment
E. Etc.
The acceptance of the equipment supplied by Comecer from the user implies that user considers it appropriate to be used
in the specific conditions of the process, and possible further risks are managed by the user with no impact on the supplied
equipment.
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3.7.5 Mandatory glove use
When handling products on the machine it is mandatory to

wear protective gloves.
3.7.6 Prohibitions
It is forbidden to:
- Use the equipment for other scope than what is specified
in this manual;
- Use the equipment with explosive or flammable substances;
- Use materials and substances not validated;
- Use components not suitable with the devices supplied;
- Remove or tamper with any type of protection or safety
device supplied with the machinery;
- Install components with other featured than what was
expected by the Manufacturer;
- Climb on the machinery.
DANGER
The failure to observe the prohibitions in this chapter can cause severe damage to the equipment and
at the same time put the operator and people in the surrounding area at great risk.
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4 HANDLING AND INSTALLATION INSTRUCTIONS
ATTENTION
During all handling and installation operations, it is mandatory to comply with the relevant standards
in force regarding safety in the workplace.
ATTENTION
COMECER declines all liability for damage caused by incorrect operations, operations performed by
unqualified personnel or use of unsuitable means.
4.1 PACKAGING
COMECER uses wooden crates for packaging that are closed on all sides and rested on a pallet dimensioned for the weight
of the content and transport.
INFORMATION
The crates contain the equipment and the supplied parts, either loose or packed, in cardboard boxes.
CAUTION
When the material is delivered please check (visually with the carrier) the perfect integrity of the
packaging; if the crates have been damaged during transport, report it to a manager as it could imply
that the machine has undergone damage inside the crates.
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4.2 TRANSPORT AND HANDLING THE PACKAGED EQUIPMENT
ATTENTION
The machine must be unloaded from the means of transportation and removed from its packaging
by COMECER or the user’s qualified personnel, if the latter is properly trained and authorized by the
manufacturer.
ATTENTION
All equipment used to lift and transport the machine must be selected according to the dimensions,
weights and shape of the equipment and its components.
The capacity of the lifting means must exceed the weight of the components (with a margin of safety)
that are to be transported.
It is absolutely forbidden to handle the packaged equipment by securing it with belts, ropes or chains;
the packaging may not withstand the forces exerted by these tools.
Use a forklift with suitable capacity (see “Technical data” in chapter 2 and Packing List).
Make sure the forks are not shorter than the depth of the package to be lifted.
ATTENTION
Lifting operations must be continuous, avoiding jerky and sudden movements.
ATTENTION
During handling operations, nobody is allowed to remain in the manoeuvring area, as this is considered
a dangerous area. The person in charge of the handling operations is responsible for making sure that
the load is stable before lifting and handling it.
ATTENTION
Do not walk or stop beneath suspended loads.
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The means used to lift and to transport the packages must be able to lift the
equipment weight (Capacity ≥ 5000 Kg). They must be forklift trucks.
Transport should possibly be carried out for short distances, trying to avoid any
jerks as much as possible.
If possible, place the crate near the place of installation
Ensure that the length of the forklift or transpallet forks is not shorter than the
depth of the package to be lifted.
Transport and handling must be carried out using lifting devices of adequate
capacity for the load. The various parts must be positioned correctly, so as to
guarantee safe transport. The gross weight of every load is indicated outside
the packaging.
Any equipment handling must be carried out with great care. Always contact a
manager to receive indications regarding how and where to deposit the load.
Transport must be performed by just one operator. Always keep a distance of at
least 3 metres when the machine is handled.
Lift the machine smoothly and WITHOUT jolts in order to ensure the stability
of the system. The load must be lifted to a height that MUST NEVER EXCEED
20 cm from the ground. Within this limit the lifting height must be evaluated
in consideration of the roughness of the ground. If lifting is reduced, the risk
of damaging the equipment and injuring the operators is limited. The ground
where the machine is handled must be flat. During transport always proceed at
a walking pace.
4.3 STORAGE
If the equipment is not installed immediately after delivery, but must be stored for a long period of time, it is advisable to
keep all components in their original packaging and stored in a covered area, suitable for the required level of protection.
Make sure that the environment features correspond to:
• Temperature: +2/+45°C;
• Max. relative humidity 90% (not condensed);
• Closed area, protected from the external weather.
• Temperature or humidity values exceeding those indicated above may cause serious damage to the components.
Make sure that the support surface is strong enough to support the weight of the equipment
Never place the equipment near flammable material.
If the panel and other components are removed from their original packaging:
• always place a wooden or other type of platform between the floor and the components, to prevent direct contact with
the floor itself;
• protect all unpainted parts using oil or grease-based anti-oxidising products;
• cover the components with a plastic sheet to protect them from dust and humidity.
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4.4 DISPOSING OF THE PACKAGING
Dispose of the packaging materials separately, in compliance with the

applicable standards of the country where the machine is used.
The materials bearing the symbol at the side can be recycled. This requires
placing them in specific spaces and/or bins.
Seek information by contacting the relevant authority.
4.5 TRANSPORT AND HANDLING THE UNPACKAGED EQUIPMENT
The equipment is equipped with lifting eyebolts fixed on the roof and accessible
from inside the top cover.
Attach the ropes or hooks of the crane or equipment suitable for the eyebolts
and lift the appliance slowly. Transport should possibly be carried out for short
distances, trying to avoid any jerks as much as possible.
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4.6 INSTALLATION
INFORMATION
Installation and start-up operations must be performed by COMECER or the user’s qualified personnel,
if the latter is properly trained and authorised by the manufacturer.
INFORMATION
Use suitable tools to check the conditions of the power mains and of the earth connection.
INFORMATION
Do not tamper with parts of the equipment regulated and/or preset during the final testing phase.
INFORMATION
Any technical modifications with consequences on functioning and/or safety of the equipment
must only be performed by COMECER technical personnel or by technicians formally authorised by
COMECER. Otherwise, any liability for changes or damage will be declined.
INFORMATION
It is prohibited to modify the original installation settings without COMECER’s authorisation.
4.6.1 Installation conditions
The customer is responsible for:

1) Preparing the area (brickwork, foundations, ducting). The customer must set-up suitable areas according to the
requisites of the European Directives regarding safety in the workplace. In particular, there must be enough space for
use and maintenance. The floor of the room where the machine will be positioned must be flat and level.
2) The set-up of the power supply, with relative connections to the site’s earthing system, up to the power supply points
of the equipment. The power supply system (customer’s power distribution board) must include:
2.1) Protection against overcurrents: fuses or circuit breaker switches sized depending on the length and cross-section
of the power cable.
2.2) Protection against indirect contact:
•• TN-S system: specific device not mandatory (cable length according to Tab.10 IEC/EN60204-1, if power source
impedance of installation site less than 400mOhm).
•• System other than TN-S: implement in accordance with the local regulations governing the installation site.
INFORMATION
Where required, it is recommended to install adjustable residual current devices to avoid unneeded
triggering due to the presence of motor drives (and relative leakage currents).
3) Set-up of auxiliary services suitable for equipment requirements;

4) Tools and consumables required for mounting and installation.
Pag. 61/176
4.6.2 Installation procedure - routine operations
A. Assistance for unloading the materials and loading them onto the trolleys.
B. Movement (pull and push) of materials to installation or temporary storage point
C. Ceiling-mounted plates for installing hoists
D. Installing the materials using the hoists described above
E. Hydraulic and electric connections
F. Inspection of the cell or isolator installed
4.6.3 Carrying out installation operations
1) The materials arrive by lorry equipped with a crane at the installation site. COMECER S.p.A. operators help with
unloading the materials, without interfering with the operations. Only COMECER S.p.A personnel must be present in
the material handling area. The operators direct the lowering of the materials, staying out of the fall radius of the load.
Handling is performed by lifting trucks (driven by correctly trained external personnel) if requested by the customer
in the site meeting phase, or also using electric transpallets. During the site inspection phase, the routes to be taken
with the materials are verified and it is decided whether ramps are required (which will be produced in the COMECER
S.p.A workshop, if necessary) along with the type of vehicles that are most suitable for reaching the area of installation.
2) Before starting handling, the Manager asks the person in charge (Prevention and Protection Manager of the structure in
question) to collaborate to prevent unauthorised persons from interfering with the handling phases and to make sure
that no one is present, even as an observer, along the passage of the load. If deemed appropriate also by the internal
safety service of the structure, it is recommended to temporarily close the doors of environments facing the passage
area, in order to prevent interference. In the event of a site with several companies present, the respective Managers
must be previously informed of the risks present during handling in question and of the necessity to evacuate the areas
of interest.
3) As soon as the COMECER S.p.A. operators reach the installation area, they will attach the plates to the ceiling for
installation of the hoists used to handle the materials to be installed. If, during the preliminary site inspection, it was
seen that the ceiling was not able to support these loads, the operators will install a power lift.
4) As soon as the hoists have been positioned, the operators can start to assemble the equipment. The materials being
stored temporarily are placed in the immediate vicinity of the work area and, on requirement, are handled using a
transpallet or lifting trolley if the work area allows this to be possible. The handling and installation phases of the
materials must only be performed by COMECER S.p.A. specialised operators and for no reason should any operator be
in the radius of any falling loads.
5) The successive connections to the electric and hydraulic plants are performed by COMECER S.p.A. specialised personnel
and takes place after disconnection of the circuits of interest from the connection operations. It is important in this
phase that for no reason personnel foreign to the work makes manoeuvre on the plants in question.
4.6.4 Means and equipment used
The following means of transport can be used in this phase:

• To unload, use the carrier’s crane that has made the delivery of the materials, forklift truck, hydraulic lifting devices,
sliding trolleys, pallet trucks (possibly electrical).
• To apply the wall plates, use: masonry drill, pressure caps. To fence off the area, coloured tape and no entry signs.
• Hoists are used in the materials handling phase.
• In the connection phase to the electric and hydraulic systems, only use manual equipment.
• The inspection phase is mainly visual.
Pag. 62/176
4.6.5 Levelling
The floor of the room where the equipment will be positioned must be flat and level.
4.6.6 Installing the filters
When installed, the machine is supplied with all of its relative filters.
For each filter shown in the table below, the machine features a differential pressure gauge (manual or digital) in order to
follow up the jamming status (For further information, please refer to the P&ID layout attached).
When the ventilation is started-up for the first time and after each single filter replacement, the operator is to record the
value shown by the relevant pressure gauges and keep them monitored periodically.
On the basis of instructions available in the datasheets of installed filters, it is recommended to replace them when they are
jammed.
By a way of example, the replacement of a filter can be scheduled when the value read on the differential pressure gauge is
double than the value originally recorded.
Description Function
U15 absolute filter Main chamber unidirectional/laminar air flow filtering
U15 absolute filter Main chamber air filtering in return
U15 absolute filter Pre-chamber air filtering in return
U15 absolute filter Pre-chamber unidirectional/laminar air flow filtering
Pag. 63/176
4.7 MANAGING OUTGOING ENABLING SIGNALS FROM THE MACHINERY
CAUTION
Connection between COMECER electrical wiring and other devices for sending and/or receiving
enabling signals must be carried out by an authorised technician. Before proceeding with any
operation, contact Comecer.
The machine is designed for sending enabling signals to customer as per wiring diagrams enclosed.
The enabling signals the machine is located inside the electrical panel.
They are:
• Isolator status
INFORMATION
For more information, refer to the wiring diagrams provided in the annex.
4.8 CONNECTION TO THE ENERGY SOURCES
4.8.1 Power Supply
In order to ensure proper installation and smooth operation, the equipment must be supplied with a power line as follows:
For Europe
& similar
4.8.2 Pneumatic power supply
In order to ensure proper installation and smooth functioning, it is necessary to set up a line of compressed air for the main
pneumatic supply.
The equipment has pressure reducers with relative pressure gauges, which regulate the pressure of the primary and
secondary pneumatic lines.
Minimum pneumatic supply 25 nL/min | 6 bar | 1/2”G female

Compressed air quality Class 1.4.1 or higher (ISO 8573-1)
INFORMATION
The absence of compressed air is signaled by the relevant alarm.
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5 PRECISION ADJUSTMENTS AND SET-UP
When installed, the machine is fully adjusted and does not require any further adjustments.
ATTENTION
Do not edit the parameters set by Comecer technicians.
Incorrect settings can cause the equipment to malfunction, with consequent risks for the operator.
If necessary, request COMECER after-sales assistance for any adjustments or regulations not included
in this chapter.
Pag. 65/176
6 OPERATING RULES
6.1 OPERATOR POSITION
The following illustration shows the positions that the operator must be in during the work cycle, for his own safety.
Pag. 67/176
6.2 DESCRIPTION OF CONTROL PANELS, COMMANDS AND INDICATOR LIGHTS
6.2.1 Operator Panel
The equipment has one or more 9” touch screen operator control panels
suitable for use with gloves.
The operator control pane allows for the traceability of critical system
parameters both at rest and in operation.
The control panel further allows for equipment management avoiding the
use of buttons and switches, allowing for a surface which can be entirely
decontaminated and sterilised.
Particular elements of the system include the use of large icons and pages
dedicated to single critical parameters, notwithstanding the possibility of
continually viewing a panorama of parameters to be controlled on the front
page.
The control panel can simultaneously monitor more than 100 parameters with
relevant warnings and alarms for complete control of the equipment and its
components.
Up to 8 password levels with different privileges can be entered and up to 21

operators with dedicated Usernames and Passwords can be set, in order to
trace the operations performed.
The operator panel allows you to save all the logs in an internal memory buffer.
ATTENTION
The customer’s SOP (Standard Operating Procedure) is in charge of managing passwords for user
level access.
ATTENTION
Each operator must log out at the end of their working operations or before leaving the machine to
prevent uncontrolled access or safety system bypassing by unauthorised personnel.
INFORMATION
For further information, see the attached operator panel manual.
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6.2.1.1 User levels
There are four user levels:

• Users: Basic use of the equipment;
• Maintenance: User Authorisations + Equipment parameter changes;
• Administrator: Maintenance Authorisations+ Creation of users.
• Comecer Administrator: Administrator Authorisation + Changes to “Setup” page.
INFORMATION
ATTENTION
level access.
ATTENTION
Pag. 69/176
6.2.2 Data transfer
Critical data can be exported according to the following modes:

1- standard: USB port at the front of the equipment - side (see fig).
2- on request: Ethernet connection from PLC for transferring instantaneous
values; the reception and storage of these values must be carried out from the
customer’s system (PC, SCADA, etc.).
As for the second mode, Comecer can provide:

• PLC Ethernet connection (switch ETH)
• Software export data
• Documents with data interconnection specifications.
Comecer does not supply:
• Ethernet cable
• Data acquisition external system
Pag. 70/176
6.2.2.1 Data transfer mode lay-out
ETHERNET cable
USB cable
B
PLC
C
HMI
D
E
A
F
1 2
Ref. Description
A USB key (not supplied)
B USP port
C HMI internal memory
D Ethernet Port on PLC
E Switch ETH
F External Computer (responsibility of the customer)
Pag. 71/176
6.3 PRELIMINARY OPERATIONS
6.3.1 Normal start-up
The isolator and the VPHP generator are equipped with independent power supplies and each has its own electrical switch.
To power both pieces of equipment:
ON
To power the equipment, turn the electrical switch to “ON”.
ON
Make sure that the electrical maintenance switch for the VPHP generator is set
to “ON”.
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6.4 NORMAL STOP
Through the operator panel stop the actuators and the instrumentation that may be installed inside the machine.
Switch off all control PCs, if any.
To cut off power to both pieces of equipment:
To disconnect the equipment, turn the electrical switch to “OFF”. OFF
INFORMATION
The circuit breaker is red with yellow background because it also serves as an emergency switch.
By turning the circuit breaker, the power supply to the machine is cut off by an electro-mechanical
actuation.
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6.5 EMERGENCY STOP
The machine is equipped with one or more emergency buttons that stop the equipment safely.
Pressing the emergency buttons stops:

• Distribution of peroxide, if the sterilisation process is enabled.
ATTENTION
The operator must press the emergency button only to safely stop the VPHP generator in the event of
an emergency.
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6.6 USING THE EQUIPMENT
As owner of the system, the Customer is to define the internal procedures for the proper management of the entire batch of
production.
In this chapter we are describing the instructions for the proper functioning of single parts which the machine/line is made
up of.
WARNING
The instructions described below do not replace customer internal procedures (SOP) for the
management of inward material and to avoid machinery contamination.
6.6.1 Ventilation
To activate/deactivate the internal ventilation, use the relative controls on the touch screen operator panel.
INFORMATION
6.6.2 Lighting
To activate/deactivate the internal lighting, use the relative controls on the touch screen operator panel.
INFORMATION
6.6.3 Decontamination
INFORMATION
For further information, see the attached VPHP generator user and maintenance manual.
Pag. 75/176
6.6.4 Opening/Closing doors
6.6.4.1 Front doors
Manually opening
To open the door, use the relative handle after the deflation of the gasket through the control panel.
INFORMATION
Manually closing
Use the special handle to close the door and control gasket inflation from the operator panel.
ATTENTION
Be careful not to trap your gloves when closing the door.
If they are damaged, you will need to replace them, as described in the chapter on “Gloves replacement”.
6.6.4.2 Internal communication door
Manually opening
Use the handle to open the door after deflating the gasket from the operator panel.
INFORMATION
Manually closing
Use the special handle to close the door and control gasket inflation from the operator panel.
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6.6.5 Liquid waste compartment
6.6.5.1 Insertion and connection of liquid waste containers
Proceed as follows to insert containers in the liquid waste compartment:

To open the door, use the relative handle.
Position the liquid waste container on the trolley.

Near the machine, lower the carrying handle, releasing the relative locking pin.
Insert the trolley inside the specific compartment.
Connect the pipe with the corresponding quick coupling.
Close the door.
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6.6.5.2 Extracting liquid waste
CAUTION
The equipment is not fitted with sensors and indicators that detect and report the fill status of the
liquid waste container.
Therefore, the operator must visually check the fill status of the container and dispose of the waste
when necessary, to prevent it from overflowing.
The container for liquid waste must be extracted and replaced following the instructions described in the Customer’s SOP
(Standard Operating Procedure).
To dispose of liquid waste, follow the instructions in the SOP (Standard Operating Procedure) of the Customer.
Proceed as follows to extract waste:
To open the door, use the relative handle.
Disconnect the quick coupling of the pipe.
Remove the trolley.

Lift the carrying handle, releasing the relative locking pin to facilitate handling.
CAUTION
Do not dispose of pollutants into the environment. Dispose of the materials in compliance with the
relevant regulations in force.
Close the door.
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6.7 STATUS OF THE EQUIPMENT
The status of the equipment (normal status or alarm status) is indicated on the touch-screen operator panel.
INFORMATION
6.7.1 Light indicator with buzzer to press internally
The equipment is fitted with a buzzer to acoustically and visually signal the pressure status inside the chamber.
6.7.1.1 Green light
The steady green light indicates that the machine works regularly: the doors are
closed, operating pressure is in the intended range, no anomaly/alarm is active
and chamber is sterile (when the VPHP generator is present).
The blinking green light indicates: machine in preparation, e.g. sterilization

cycle in execution (when the VPHP generator is present).
6.7.1.2 Yellow light
The steady yellow light indicates: Chambers in faulty condition or presence of

an alarm not connected with operator safety . Control and/or intervention by
operator necessary to restore the correct operation.
INFORMATION
For more information on the current status of the machine, refer to the operator panel.
6.7.1.3 Red light
The blinking red light means: Emergency – Dangerous condition for which
immediate action by the operator is required.
INFORMATION
For more information on the current status of the machine, refer to the operator panel.
Pag. 79/176
7 MAINTENANCE
CAUTION
All the maintenance interventions not included in this chapter are to be performed by an authorised
COMECER technician.
ATTENTION
The electrical panel is equipped with a lock; the key should be held by the person in charge of
maintenance, who must lock it again after completing the maintenance operations.
7.1 WARNINGS REGARDING MAINTENANCE
Production managers and operators in charge of maintenance must comply with all the prescriptions issued by the Safety
Bodies when carrying out the specific operations listed in this chapter.
Maintenance, cleaning and removal of equipment components and devices must only be carried out by specialists.
It is good practice to use only original spare parts for repairs to ensure the safe operation of the equipment. Should additional
instructions be required or particular problems arise, do not hesitate to contact the manufacturer. To prevent malfunctions
that could directly or indirectly create serious accidents, injuries to persons and damage to materials, it is important to
comply with all instructions described on the equipment, on the layouts and in this document.
Make sure that the tools available are suitable for use; prevent any misuse of the tools or equipment.
7.1.1 General information
Maintenance must only be performed by the following persons:

A. operator who performs general inspections and cleaning operations;
B. maintenance technician who performs adjustments and replaces parts;
C. manufacturer’s after-sales assistance who performs special maintenance (COMECER).
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7.1.2 Precautions and setting the machine in maintenance mode
The maintenance personnel must be aware that maintenance operations can pose risks. It is therefore necessary to respect
all instructions found in this use and maintenance manual starting from general instructions concerning the preparation of
the equipment for maintenance.
It is of fundamental importance:
A. To avoid any physical contact with the moving parts;
B. Unskilled and unauthorised personnel cannot access the work area when the equipment is under maintenance;
C. The maintenance operations that require the presence of electric power, such as troubleshooting in the electric
boxes, must be carried out only by authorised personnel, who must follow the safety procedures in force within the
establishment;
D. Maintenance operations above 2 m from the ground are carried out using suitable and standard means (ladder, helmet,
etc.);
E. Use the required personal protective devices are used;
F. All equipment maintenance operations must be carried out:
F.1 Only in the absence of electric/pneumatic power based on the type of intervention.
F.2 When the area is well lit. In case of maintenance in areas that are not sufficiently lit, use portable lighting devices
and avoid cones of shade that could hinder or reduce visibility in the area of operation or in the surrounding areas
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7.2 ISOLATING THE MACHINE FROM ENERGY SOURCES
The equipment requires connection to different energy sources. Based on the maintenance operation to be carried out, it
may be necessary to isolate the equipment from one or more energy sources, according to the instructions provided in this
manual.
ATTENTION
Prior to carrying out any maintenance job, carefully read the instructions contained in the manual.
7.2.1 Electrical supply sectioning
OFF
To disconnect the equipment, turn the electrical switch to “OFF”.
INFORMATION
actuation.
OFF
For maintenance operations on the VPHP generator, it is possible to proceed

with local disconnection by means of the relative on-board electrical switch.
Pag. 83/176
7.2.2 Disconnecting the pneumatic supply
To disconnect the pneumatic supply close the inlet valve.
Refer to the pneumatic diagram to manually deflate the inflatable gaskets.
Pag. 84/176
7.2.3 Locking device for maintenance
The devices used to cut out power installed on the equipment and described in this instructions manual were designed to
allow the insertion of lockout and tagout devices in the “safe” or “off” position.
The images provided here below are application examples of such devices.
The Lockout-Tagout (LOTO) procedures must be provided for by the employer.
These procedures must indicate the location of the lockout (tagout) device in each power cut-out device, so that the latter
and the controlled equipment cannot be used until the lockout has not been removed.
The lockout and tagout devices must be applied to the individual power cut-out devices by authorised personnel
(maintenance technicians).
DANGER
Lockout devices and tagout devices provided by the employer shall be suitable for the purpose (e.g.
shall be singularly identified, shall be capable of withstanding the environment to which are exposed,
shall be standardized within the facility, shall be substantial enough to prevent inadvertent or
accidental removal, shall indicate the identity of the employee applying the device(s), etc.).
1 2
Pag. 85/176
7.2.4 Dissipation of residual energies
After isolating the equipment, the maintenance technician has to make sure there are no risks deriving from residual energy
(e.g., pressurised circuits, condensers, inertias and suspended loads, hot parts, etc.).
For this aspect, please refer to the paragraph on residual risks of this manual
If necessary, prior to proceeding the maintenance technician must wait for this residual energy to be discharged or arrange
for discharging it directly (for example, by discharging the pressure according to the instructions found in the pneumatic
diagram).
7.2.5 Verification of the safe state (isolation)
Prior to starting work on machines or equipment that have been locked out or tagged out, the authorized employee shall
verify that isolation and deenergization of the machine or equipment have been accomplished.
7.2.6 Release from lockout or tagout
Before lockout or tagout devices are removed and energy is restored to the machine or equipment, procedures shall be
followed and actions taken by the authorized employee(s) to ensure that:
• The work area shall be inspected to ensure that nonessential items have been removed and to ensure that machine or
equipment components are operationally intact;
• The work area shall be checked to ensure that all employees have been safely positioned or removed.
7.2.7 Temporary removal of the Lock-out devices
If the Lock-out devices must be temporarily removed to verify equipment or system operation and then applied once again,
it is important to:
1) Move materials and instruments used away from the equipment and/or system;
2) Check that all personnel is in safe position, away from any moving and/or live parts when the equipment and/or system
are re-activated;
3) Remove the lock-out devices.
4) Re-power and check equipment and/or system operation.
5) Isolate the power sources.
6) Re-apply the lock-out devices.
7) Continue with maintenance activities.
7.2.8 Interventions over several work shifts
If maintenance extends over several work shifts, the work supervisor, who applied the Lock-out procedure in the first place,
during his shift, must transfer the responsibility of the procedure to the supervisor of the incoming shift. The latter must then
place his own lock-out device on the isolating/disconnection devices and update the relative personnel and the incoming
personnel. This procedure must always be implemented every time there are shift changes and/or the assigned or relative
personnel changes.
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7.3 PERIODIC CHECKS
ATTENTION
COMECER declines all liability due to lack of maintenance of the equipment, as shown in the table of
periodic inspections.
INFORMATION
“XXX” generally signifies a component which belongs to the type identified by the TAG. Please refer to
the P&ID supplied with the machine for further details.
7.3.1 Every day and before starting the processing cycle
Activity description Person in charge

Verify that there are no alarms on the HMI. In the presence of alarms, proceed according to the
Operator
“Alarms list” chapter in the operator panel manual
Before carrying out any internal processing operations, make sure that the red or yellow light
Operator
on the luminous indicator is OFF
Check the filling state of the liquid waste container. If necessary, empty it. Operator
If present, visually check that the installed gloves are in good condition and that there are no
Operator
cuts or damage. Also make sure they are positioned correctly on their respective flanges.
Proceed with a leak test to verify that the chambers maintain the insulation. Verify that the leak
Operator
test is performed before each sterilisation cycle.
Clean the inside of the chambers with suitable products. For more information, please refer to
Operator
the “Cleaning” chapter in this manual.
Check that the instruments installed inside the chambers are on and functional and no alarm
Operator
signal is present.
Verify on the panel/pressure gauge that the pressure ranges inside the chamber are as
expected. In case significant variations are noted with respect to working pressure (ΔP>10 Pa),
proceed as follows: Operator/Maintenance
technician/Comecer to
1. Check pressure parameters for proper setting on the HMI; replace and calibrate
2.Check filters for clogging; instruments
3.Check transmitters/pressure gauges for proper operation and calibration.
7.3.2 Weekley

Check proper operation of the luminous/sound indicator Operator
Operator/Maintenance
Check the integrity of the gloves using the special glove tester.
Engineer
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7.3.3 Every month

Make sure the light bulbs installed inside the chambers work correctly. Replace them, if Operator/Maintenance
required. technician
Verify the air flow inside the chamber with a suitable calibrated external anemometer and
compare the reading with that of the anemometer installed inside the chamber (Ref. P&ID - SE
“XXX” / ST “XXX”).
- If the values differ, contact Comecer to have the anemometer calibrated. Operator/Maintenance
technician/Comecer for
- If the values are not within the accepted range for LAF chambers (0.45 ± 20 % m/s, according
calibration
to EU GMP Annex, verify:
1. the parameters set on HMI
2. the clogging and integrity of the filters.
Verify the temperature and humidity inside the chamber with a suitable calibrated external
Operator/Maintenance
instrument and compare the reading with that of the temperature/humidity sensor installed
technician/Comecer for
(Ref. P&ID MTE or TE or GE “XXX” / MTT or GTT “XXX”) inside the chamber. If the values differ,
calibration
contact Comecer to have it calibrated.
Use a suitable calibrated external instrument to verify that the ranges of pressure inside the
chambers are in line with that indicated by the pressure gauges/transmitters.
- If the values differ, contact Comecer to have the pressure gauges/transmitters calibrated;
- Proceed as follows if significant variations are noted with respect to the working pressure Operator/Maintenance
(AP>10 Pa): technician/Comecer for
1. verify the set pressure parameters on the HMI; calibration
2. verify filter clogging;

3. verify that the pressure gauges/transmitters work correctly and are calibrated properly. (Ref.
P&ID - PDT 01301; PDT 03301)
Check that the connections to the liquid waste container Maintenance technician
Check that the connections to the particle monitoring tools are in good condition (Ref. P&ID -
Maintenance technician
QT 01801 / QE 01801).
7.3.4 Every three months

Verify that the door closing sensors work correctly by performing simulations on the control
Operator
panel.
Visually check the level of liquid inside the water separator of the air treatment unit in the
Operator
pneumatic panel
Visually check the condition of the inflatable gaskets on the machine and make sure there are Operator/Maintenance
no cuts, wear and/or friction. technician
Verify the integrity of the machine’s electrical disconnection device. Maintenance technician
Visually check the condition and proper operation of the VPHP recirculation pumps (Ref. P&ID
- M 01601; M 01801; M 01901). In case of anomalies contact Comecer.
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7.3.5 Every six months

Verify that the control panel and USB/ethernet ports work correctly Operator
Visually check that the parts of the isolator that deteriorate (e.g. doors, alpha doors, gaskets, Operator/Maintenance
hinges, gas handles and springs) are in good condition. technician
Verify the integrity of the filters with DOP test (ref. “DOP test” in pneumatic scheme) Maintenance technician
Visually check that the electric cables, pneumatic pipes and the components inside the
electrical and pneumatic panels are in good condition.
Check for proper operation of the emergency button . Maintenance technician
Maintenance technician/
Check and calibrate the Dräger sensor for VPHP (Rif. P&ID - AT 03312 / AE 03312)
Comecer
7.3.6 Every 1000 hours of operation, and in any case, every year

Replace all of the filters. After replacing the filters perform the DOP test (Ref. “DOP main
chamber” in the pneumatic diagram)
7.3.7 Yearly or as indicated in the user manuals of the instruments

Calibrate the temperature/humidity sensors (Ref P&ID MTE or TE or GE “XXX” / MTT or GTT
Comecer
“XXX”).
Calibrate the pressure transmitter (Ref. P&ID PDT “XXX”) Comecer
Calibrate the particle counters (Ref. P&ID - QT 01801 / QE 01801) Comecer
Calibrate the anemometers (Ref. P&ID - SE “XXX” / ST “XXX”) Comecer
Maintenance Technician/
Check and calibrate the ATI sensor for VPHP (Ref. P&ID - AT 03301 / AE 03301)
Comecer
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7.3.8 Every year

Verify that the pictograms on the line and the tags within the electrical and pneumatic panels
are still present and legible.
Verify that the laminar flow works properly (e.g. Air Speed Test, Smoke Test)
Comecer
Verify the air quality inside the chambers with suitable external instruments and compare the Maintenance technician/
readings with those of instruments for particle monitoring (Ref. P&ID - QT 01801 / QE 01801). Comecer
Verify that the cooling fans inside the electrical panel work, if present and if necessary, clean or Maintenance technician/
replace the filters. Comecer
Replace the filters inside the pneumatic panel Comecer
Check proper operation of automatic valves (Ref. P&ID - AV “XXX”; XV “XXX”; FCV “XXX”) and of
Comecer
the corresponding positioning sensors (Ref. P&ID - XV “XXX”; ZS “XXX”).
Check correct operation of the outlet fans (Ref. P&ID - M 01031; M 03031). Comecer
Check correct operation of the LAF fans (Ref. P&ID - M 01081; M 01082; M 01083; M 03081). Comecer
Contact Comecer for routine maintenance. Comecer
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7.4 DESCRIPTIONS OF ADDITIONAL PERIODIC CONTROLS
7.4.1 Verify the calibration of the measuring systems installed, and calibrate if necessary
Refer to the user manuals of the individual instruments for such operations.
7.4.2 Filter integrity testing - DOP test
To enable execution of the integrity checks of the filters, COMECER provides “DOP TEST” outlets.
These connections allow sampling in areas otherwise inaccessible and must be connected to the “UP STREAM” or “DOWN
STREAM” lines of the photometer (not supplied).
The “UP STREAM” line allows reading the concentration of aerosol upstream of the filter that the instrument uses as an
internal reference of 100% of the aerosol.
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7.4.3 Verification of glove tightness via “on board” AGT
The system allows you to test an individual glove for each cycle.
Plug in the AGT system as shown in the figure.
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Position the flange of the AGT on the glove to be tested and command inflation
of its inflatable gasket by pressing the button on the flange.
Position the flange of the AGT on the glove to be tested and command inflation of its inflatable gasket by pressing the button
on the flange.a.
Enter the glove ID on the operator panel to identify the glove to be tested.
Press START on the operator panel. The ABORT button is disabled during the test.
The glove begins to inflate following positive pressure created around it until it reaches a preset value.
If the pressure value remains stable, the instantaneous pressure of the glove is recorded and a timer starts automatically.
After a preset amount of time, the instantaneous pressure of the glove is compared with the pressure of the glove recorded
previously:
· if the pressure drop is less than the preset value, the leak test is passed
· if the pressure drop is greater than the preset value or the initial pressure inside the glove has not stabilised, the leak test
is failed.
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7.4.4 Check the liquid level of the water separator of the air handling unit of the pneumatic board
Visually check the level of liquid inside the container for the collection of condensation from the water separator on the air
handling unit. Empty the container if necessary.
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7.5 COMECER REMOTE SUPPORT NETWORK ENABLING
If necessary, Comecer offers remote machine assistance.

By means of a coded key, the Customer can control and enable access via internet to Comecer technicians on the local
system.
To enable access, turn the key “ON”; to disable access, turn the key “OFF”.
Pag. 95/176
7.6 REPLACING THE FILTERS
DANGER
It is important to clean the interior of the equipment work chamber before performing any
maintenance (disable the product) in order to prevent the maintenance personnel from running the
risk of contamination. They must always use disposable non-woven fabric lab coats with a hood, a
cartridge face mask or with forced carbon filtered air intake, gloves and disposable overshoes. Specific
cleaning materials and accessories must be used.
INFORMATION
After the filters are removed from the equipment, they must be placed in double enclosure systems
to be sealed hermetically (for example using a heat sealer), considered as toxic-harmful, must be
deactivated and then disposed of.
Gloves, overshoes and overalls used for maintenance must be removed in the same room where the
equipment is installed and must also be disposed of as toxic-harmful waste.
At the end of the operation, restart the machine and wait a few seconds so that optimal conditions of
the chambers can be re-established.
Make sure there are no other alarms left.
7.6.4.1 Inlet filters
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Proceed as described below to replace the filter:

Access the technical cabinet where the component is housed.
DANGER
Before starting any operation, disconnect electrical power supply.
For more information, consult the chapter “Isolation of the equipment from energy sources”.
Unscrew the fastening screws of the frame.
Remove the support frame.
Remove the filter.
Replace the filter.
Reassemble that described above in the inverse order.
Pag. 97/176
7.6.1 LAF filters

Access the relative chamber (main chamber, pre-chamber, etc.) housing the component.
INFORMATION
For further information, please refer to the chapter “Door Opening/Closing” in this manual.
DANGER
Disconnect the power supply.
For more information consult the chapter on “Isolating the equipment from energy sources”.
If present, remove the rod with hooks;
Pag. 98/176
Lift up the air diffuser and pull it;
Remove the air diffuser;
Unscrew the fastening nuts of the filter support flange;
Remove the filter support flange;
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Remove the used filter;
Replace the filter.
Insert the new filter;
Insert the filter support flange;
Screw the clamping nuts of the filter support flange;
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Place the air diffusor into its supports;
Lift up the air diffusor to its locked position;
Insert the rod with hooks.
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7.6.2 Air intake filters
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Access the relative chamber (main chamber, pre-chamber, etc.) housing the component.
DANGER
Disconnect the power supply.
For more information consult the chapter on “Isolating the equipment from energy sources”.
If present, remove the shelves.
Remove the deflector by loosening the relevant screws.
Remove the filter.
Replace the filter.
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7.7 REPLACING THE LAMPS
Pag. 104/176
Proceed as described below to replace the lamp:
DANGER
Unscrew the screws to remove the light holder, taking care not to break the
power supply cable.
Unscrew the lamp from its holder.

Disconnect the connector and replace the lamp.
Change the bulb.
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7.8 CHANGING THE GAS SPRING
Pag. 106/176
To replace the gas spring, open the relative door (from operator panel or control panel) and proceed as described
below:
ATTENTION
The operations described below require the participation of at least two operators.
Operator “A” opens the door.
While operator “A” holds the door open, operator “B” removes the old spring by
unscrewing the relative clamps.
Change the gas spring.
WARNING
For the correct assembly of the gas springs check that they are positioned as represented in the
previous images.
Pag. 107/176
7.9 REPLACING THE GLOVES
The gloves are fixed with flanges, for replacement, proceed as follows:
Unscrew the screws on the outer flange
Remove the outer flange
Remove the inner flange on which is mounted the glove
Pag. 108/176
Replace the glove, making sure that the seal of the glove is correctly mounted in its housing
Reposition the flange (with the glove mounted) into the hole on the inside of the door
Reposition the outer flange and screw into the holes, the 10 screws using a torque wrench (5Nm MAX)
ATTENTION
A force greater than that specified (5nm MAX) may result in the breakage of the flange
Make sure that all parts are properly assembled and that the mounting hole for
the gloves extender is positioned in upper
ATTENTION
Before proceeding, verify that the gloves are in good condition and have no cuts or incisions and make
sure they are in the correct position on the respective grooves.
Insert your hands into the gloves free from any item that could slit them (rings, watches, bracelets,
etc.)
7.10 REPLACING THE GLOVE FLANGES
To replace the flanges, follow the same replacement procedure as the gloves.
Pag. 109/176
7.11 REPLACING THE INFLATABLE GASKETS
Deflate the gasket that is to be replaced via the designated controls on the
control panel, then lift the inflatable gasket using the tip of a screwdriver,
paying attention not to damage the gasket seat;
Use your hands to pull the gasket from its housing and remove the valve,
disconnecting the rilsan air supply pipe.
Rub sandpaper over the entire gasket seat, in a way to eliminate any glue
residues and in a way to obtain a certain porosity of the base.
Accurately clean the housing of the gasket with a liquid thinner to remove any
trace of grease.
After a few minutes, clean the housing of the gasket with a dry cloth.
CAUTION
Do not use tools that could damage the inflatable gasket seat.
A B
Use your fingers to apply a layer of BOSTIK POLIMAX MS-POLIMER (A) silicone
inside the seat (B), paying attention to do so properly even at the corners of the
base (C);
Pag. 110/176
CAUTION
It is important that NO silicone is on the walls as this would hinder the correct gasket deformation,
resulting in incorrect air tightness.
Connect the air supply rilsan pipe to the valve of the new inflatable gasket;
insert the inflatable gasket valve in its hole
Divide the gasket into four parts, inserting first the 4 corners in the seat and 1
leaving the part of the gasket that runs along the sides “detached from the seat” 4 2
(Ref. 1,2,3,4) 3
Pag. 111/176
Press the gasket with your hands, starting from the upper part, then the sides
(right and left) and lastly, the lower part, to insert it perfectly avoiding uncovered
parts of the of the seat;
Use the rear part of the screwdriver to press along the perimeter of the inflatable
gasket for perfect insertion.
CAUTION
Before using the equipment and once this assembly is complete, close/insert the relative chamber
door/panel and let is set for approximately two hours for the inflatable gasket to adhere perfectly.
Pag. 112/176
7.12 CLEANING
ATTENTION
Different cleaning procedures must be carried out depending on the component material and what
type of process the machine is intended for.
7.12.1 Recommended products
The following products are recommended for cleaning and disinfecting the work areas:
• Klercida-CR Biocidal product A: filtered quaternary ammonium salts and biguanide-based bactericidal/fungicidal agent
• Klercida-CR Biocidal product B: filtered stabilised chlorine dioxide and quaternary ammonium salt-based sporicidal
agent
• KlerAlcohol IPA 70%: filtered sanitiser based on isopropyl alcohol blended with deionised water
• Klerwipe Wipe: sterile, slow particle release wipes made of polyester/cellulose, 100% polyester or polyurethane foam
INFORMATION
Biocides A and B have been tested in terms of microbiological efficacy on the following surfaces:
steel, glass, Plexiglas, melamine laminate and PVC. We recommend using Biocide A for daily or
frequent cleaning and Biocide B for periodical cleaning (weekly or every two weeks).
Isopropyl alcohol (IPA) is generally used for quick and non-critical sanitation (eg, sanitation of the
outer packaging of sterile consumables before being introduced inside the cell, quick cleaning of the
surface immediately before the work cycle starts, sanitation in the event of accidental spillage of
product onto the surfaces, etc.)
According to that indicated, the use of Biocides A and B, and IPA when required, must always be
followed by rinsing cycle using sterile water.
ATTENTION
For a correct use of the products, refer to the indications provided by the manufacturer.
Always pay attention to the material of the surface onto which each product is used.
In some cases, it has been noticed that the use of IPA on Plexiglas surfaces can cause deterioration
over time, even breaking the material, if it is not immediately removed after the application and/or
without rinsing with sterile water.
INFORMATION
To purchase the products listed above, please contact COMECER.
Alternatively to the products listed above, you can use products with the following compositions (referred to 100 ml of
product):
• BIOCIDE A: 0.5 ml of N-Alkyl (C12-16)-N, N-dimethyl-N-benzylammonium chloride and 0.2 ml of poly(hexa-
methylenebiguanide)-Hydrochloride in deionised water
• BIOCIDAL PRODUCT B: 0.92 ml of sodium chlorite and 0.29 ml of didecyldimethylammonium chloride in deionised water
• IPA: 70 ml of isopropyl alcohol in deionised water
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7.12.2 Stainless steel
It is advisable to clean the stainless steel with specific products and a soft cloth in order not to compromise the original
brightness. Do not use any product that might cause incisions or cracks, which are difficult to decontaminate.
Do not use:
• Steel wool
• Brushes
• Abrasive discs made from other metals or alloys (e.g. common steel, aluminium, brass, etc.)
• Tools that have previously processed or cleaned other metals and alloys, which, besides scratching the surface, can
contaminate the area and result in unpleasant marks.
Do not use:
• Abrasive detergents that can damage the appearance and surface finish.
• Substances to clean silver
• Hydrochloric acid (commercial muriatic acid)
ATTENTION
Any components made of any material other than steel, assembled with a steel item, must be removed
or protected before the washing process.
7.12.3 Plastic material
Neutral soap is the most suitable detergent for washing plastic materials (Plexiglas, Lexan, inflatable gaskets and plastic in
general); this must be used in an aqueous solution, applying the concentration values shown on the package. The maximum
temperature of the cleaning solution used to clean the items is 30°C. Do not use alkaline, acidic, basic or benzene solutions.
Do not use the autoclave.
ATTENTION
Do not use abrasive products or solvents (like acetone) to clean components made of Plexiglass/
Lexan, as they can make them opaque and jeopardise visibility.
Do not use products containing: Denatured ethyl alcohol, solvents in general, benzene and
trichlorethylene
CAUTION
NEVER spray the detergent directly onto the surfaces that are to be cleaned; use cloths dampened with
the cleaning solution.
7.12.4 Glass
Do not use abrasive products or solvents (such as acetone) to clean the glass; use specific glass products.
ATTENTION
Do not use abrasive products or solvents (like acetone) to clean the windows, as they can make them
opaque and jeopardise visibility.
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8 DEMOLITION AND DISPOSAL
8.1 GENERAL INSTRUCTIONS
The equipment is made from materials which do not present, when disposed of, particular dangers for the operator.
The operator or persons in charge of disposal must take into consideration that the equipment is constructed with:
• Steel: Body of the equipment, mechanical parts, electrical system parts, electrical panel, pneumatic system parts.
• Anodised aluminium: Solenoid valves, pneumatic systems components, accessory components.
• Plastic: Electrical cable covering, plastic parts of the electric components, pneumatic system pipes, protection panels,
sealing panels.
• Rubber: Gaskets, sealing components.
• Copper: Electrical cables and parts of the electrical system, electric motors.
INFORMATION
Given the complex nature of the equipment, it is advisable to contact COMECER for dismantling
operations.
In compliance with CE Directives and the laws in force in the country of installation, the user must:
1) Dispose of and eliminate the materials of the equipment to protect the environment.
2) Before demolishing the equipment, inform the manufacturer of all the data on the identification plate.
In the case of scrapping of the equipment or any of its parts, all necessary safety precautions must be taken in order to avoid
risks connected to the dismantling operations.
Special precautions must be taken during the following stages:
3) Disassembly of the equipment.
4) Transport and handling.
5) Dismantling.
6) Separation of the materials.
For the separation of the materials and their recycling or disposal, please refer to National or Regional Laws regarding the
disposal of solid industrial waste and toxic or harmful waste products. The user must, therefore, transport the waste products
(or have them transported) to the waste sorting sites set up by the local authorities or deliver the waste to the retailer
(COMECER).
8.2 DISPOSAL OF ELECTRIC AND ELECTRONIC EQUIPMENT
Components bearing the symbol indicated in the figure meet the requirements
set forth in the new standards (2011/65/CE (RoHs 2) - 2012/19/UE) introduced
to protect the environment and concerning electrical and electronic equipment
that must be appropriately disposed of at the end of their life cycle.
Contact local authorities for information regarding WEEE disposal areas.
Disposing of WEEE appropriately allows preventing potential negative
consequences. The equipment consists of non-biodegradable parts and
substances that can pollute the environment if not disposed of appropriately.
Moreover, part of these materials can be recycled, thereby preventing pollution.
It is everyone’s duty to protect the environment.
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9 ATTACHMENTS

• Specific manuals for the installed components (attached separately)
• Operator Panel Manual (attached separately)
• VPHP generator operation and maintenance manual (attached as an appendix)
This manual is completed with additional attached documentation, especially the strict requirement to use the product
correctly and safely:
• CE Declaration (attached separately)
• List of spare parts (attached separately)
• Wiring diagram (attached separately)
• Pneumatic diagram (attached separately)
• P&ID (attached separately)
Pag. 117/176
10 ATTACHMENT: VPHP GENERATOR USE & MAINTENANCE MANUAL
10.1 GENERAL INFORMATION
Read this manual and attachments carefully before performing any operation on the equipment
delivered to the final user.
INFORMATION
· Operator Panel User Manual (attached separately).
· Specific manuals for the installed components (attached separately).
This manual is completed with additional documentation listed in chapter “ATTACHMENTS”.
All of the attached documentation is strictly required to use the product correctly and safely.
10.1.1 Reference Standards
This product is manufactured in compliance with the following EU Directives:

• Directive 2006/42/EC on machinery, and amending Directive 95/16/EC (Machinery Directive)
• Directive 2014/30/EU relating to electromagnetic compatibility (EMC)
And, to the extent applicable, with the harmonized standards:
• EN ISO 12100:2010 Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO
12100:2010)
•• (following the ISO TR 14121-2:2012 - Safety of machinery - Risk assessment - Part 2: Practical guidance and examples
of methods)
• EN 60204-1:2006 Safety of machinery - Electrical equipment of machines - Part 1: General requirements (IEC 60204-
1:2005 (PEQ)
• EN 61000-6-2:2005 - Electromagnetic compatibility (EMC) Part 6-2: Generic standards - Immunity for industrial
environments (IEC 61000-6-2:2005)
• EN 61000-6-4:2007 - Electromagnetic compatibility (EMC) Part 6-4: Generic standards: Emission for industrial environments
(IEC 61000-6-4:2006)
And with the following standards and technical specifications:
• ISO 10648-1:1997 Containment enclosures - Part 1: Design principles
• ISO 10648-2:1994 Containment enclosures - Part 2: Classification according to leak tightness and associated checking
methods
The product was designed in compliance with the following requirements:
• Eudralex - Volume 4 Good Manufacturing Practices (GMP) Guidelines.
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10.1.2 Manufacturer and machine identification data
The manufacturer and appliance identification data are printed on an adhesive plate:
A. Manufacturer identification.
B. Model of the equipment.
C. Type of equipment.
D. Designation of the equipment.
E. Serial number.
F. Electrical and/or pneumatic power supply.
G. Year of manufacture.
D C
G F
INFORMATION
The equipment is defined as a partly completed machine in accordance with the Machinery Directive
2006/42/EC.
Occasionally, the equipment may be erroneously called “machine” in this manual.
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10.2 TECHNICAL SPECIFICATIONS
10.2.1 Overview
Comecer VPHP (Vapor Phase Hydrogen Peroxide) GENERATOR is a system designed to decontaminate closed chambers. It
uses dry hydrogen peroxide as a sterilising agent. The vapour distributed is created by “flash vaporization”.
The generator’s standard configuration is that of a closed loop while the open loop configuration should be considered as
a custom.
Being a device integrated to the equipment to be decontaminated, it has the following characteristics:
• It cannot operate alone and as an open system
• It allows to perform a ’leak test’ along with the chamber to be sterilised
• It is operated via the control panel (HMI) of the equipment to which it is linked
The generator can be integrated to equipment each with chambers that are configured for dry VPHP injection.
Through HMI, it is possible to select the decontamination cycles and monitor all important parameters for each phase.
The reports of the executed cycles can be exported to verify the operating parameters.
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10.2.2 Overview of the main components
7 2
8 5
9
C
6
10
A
B
11
Pag. 122/176
A
14
12
13
Ref. Description
1 Dehumidifier air outlet
2 VPHP input from the equipment to which it is connected
3 VPHP output toward the equipment to which it is connected
4 Emergency stop button
5 Technical cabinet access door
6 Front door
7 Electrical board
8 Solenoid valve for air inlet to the filter
10 Air extraction fan from dehumidifier to absolute filter
11 Drainage container
12 Predisposition for inlet Customer’s safety signals
13 Socket for electrical connection
14 Ethernet connection for data exchange with the equipment to which it is connected
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B 7 8
2
9
3 4
Pag. 124/176
Ref. Description
1 Liquid H2O2 (hydrogen peroxide) container
2 Electrical switch for maintenance
3 Loading cell (scale)
4 Secondary container for pump calibration
5 Clamp flange for filter replacement
6 Laboratory safety sensor for H2O2 (hydrogen peroxide solution)
7 Fittings for DOP test on filter
8 Solenoid valve for managing liquid hydrogen peroxide entry
9 Pump for managing liquid hydrogen peroxide entry
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1
12
3
11
4
10
5
9
8
7
Pag. 126/176
Ref. Description
1 Manual valve for VPHP outlet
3 Clamp flange for heating plate maintenance
4 Absolute filter housing
5 Calibrated disc for air from absolute filter to heating plate
6 Air extraction fan from dehumidifier to absolute filter
7 Dehumidifier
8 Air inlet fan from catalyst to dehumidifier
9 Disk calibrated for dehumidifier exhaust air
10 Fan for waste air extraction from the dehumidifier
11 Catalyzer
12 Manuale valve for VPHP inlet
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10.2.3 Kit supplied with the equipment
Two disposable kits are supplied for hydrogen peroxide solution dispensing:
• Pump Tract Kit
Composed of:
A) 2 male luer lock terminals
B) Pharmed 19F elastomer pipe
• Dispensing Pipes Kit
Composed of:
A) 2 PVC pipes with male Luer lock terminal
B) 1 PVC pipe without terminals
C) 3 PVC pipes with female Luer lock terminals
Pag. 128/176
10.2.4 Overall dimensions
480 857.5
1255
1149.5
1428.7
1097
717 591
INFORMATION
For further information on the dimensions, please refer to the attached documentation.
Pag. 129/176
10.2.5 Description of the equipment
10.2.5.1 Construction specifications
Supporting frame
Support frame made of tubular AISI steel with outer Scotch-BriteTM surface finishing. The joints are welded with TIG welding
in an argon gas atmosphere; the weld seams are ground and smoothened.
Coverings
All external coverings are realised completely in AISI 304 stainless steel with Scotch-Brite TM finishing.
10.2.6 Equipment structure
The Comecer VPHP GENERATOR consists of the following main components:

• Catalytic converter
• Dehumidifier
• Generator
• Ventilation system
• Command and control system
VPHP inlet VPHP outlet VPHP inlet VPHP outlet

ISOLATOR CHAMBER ISOLATOR CHAMBER
“Closed” loop “Open” loop

Hydrogen Rigeneration Hydrogen Rigeneration
peroxide air peroxide air
Generator Dryer Catalyst Generator Dryer Catalyst
Lab air HVAC
“Closed” loop “Open” loop
The generator’s internal configuration can be schematized in the two over-represented ways that the generator works in
“closed” loop (standard) or “open” loop (custom).
Pag. 130/176
10.2.6.1 Catalytic converter
The catalyst is a system specially designed to reduce the concentration of hydrogen peroxide (H2O2). The airflow containing
vaporized peroxide is reduced to water (H2O) and oxygen (O2) when it goes through the catalytic layer.
10.2.6.2 Dehumidifier
The dehumidifier has been designed for efficient air dehumidification. The unit
desiccant rotor absorbs humidity and is made with high efficiency composite
material to attract and retain water vapour. During the pre-conditioning
phase, it is used to reach a preset HR% value, while during the conditioning/
decontamination phase it is used to keep the physical parameters of the cycle,
stable.
The dehumidifier requires a“regeneration airflow”to maintain the dehumidifying
power over time: the unit then provides a fresh air intake (taken from the
lab itself ) and provides an output line (usually connected to the HVAC). The
air coming from the regeneration outlet line will be hot and humid and may
contain a small residue of hydrogen peroxide solution.
Ref. Description
1 Dry air
2 Regeneration air
3 Process air
4 Humid air
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10.2.6.3 Generator
The generator is able to quickly evaporate the liquid hydrogen peroxide during the conditioning and decontamination
phase by means of a heated internal plate on which the liquid peroxide is injected. This way a “flash vapourisation” of the
liquid sterilising agent is obtained. The continuous airflow generated by the generator’s internal fans allows the distribution
within the generated vapour chamber.
10.2.6.4 Ventilation system
The process air flow can be set between 30 m3/h and 70 m3/h, and the pressure of the chamber to be decontaminated
is automatically adjusted by the system throughout the cycle. An internal valve allows an automatic leak test between
the chamber and the generator. The following devices are mounted and controlled by the equipment on which the VPHP
generator is connected: The valves that isolate the chamber, the valves to open/close the branches of the VPHP and the
distribution system with which it can be possible to choose which room to sterilise in case of multiple environments. VPHP
input/output is connected to the equipment via 1 ½“ tubes equipped with clamps. The regeneration air outlet can be
connected to the HVAC via a 2“ pipe clamp. Connection features:
• For safety reasons, they should not be exchanged
• They must be sealed
• When they are not connected to the equipment (for example if the system is not working during transport), they must be
plugged in with the appropriate clamp plugs
10.2.6.5 Dose area
Inside the bottle compartment and the pump there is a 2 litre container of
sterilising agent solution placed on the loading cell that monitors the weight. At
the beginning of the cycle, the system automatically checks if there is enough
quantity in the bottle to successfully complete the selected cycle.
Pag. 132/176
10.2.6.6 Safety sensor for H2O2 (hydrogen peroxide solution)
On the front crankcase there is a low-electrochemical sensor to detect any

leakage in the outside environment that generates an alarm resulting in a
shutdown of the system, if the set threshold is exceeded. Unless otherwise
specified, the alarm level is set to 1ppm.
DANGER
ATTENTION
of the risk.
INFORMATION
When the Dräger sensor detects a value higher than the set threshold (VPHP>1ppm), the system goes
into an alarm status and blocks production of VPHP (Vapor Phase Hydrogen Peroxide)
For further details refer to the paragraph “VHP PRECAUTIONS FOR USE” and “ACTIVATION OF DRÄGER
SENSOR”
INFORMATION
The equipment is set up to be connected with external safety devices, e.g. hydrogen peroxide (H2O2)
sensors installed by Customer in the laboratory.
INFORMATION
Pag. 133/176
10.2.7 Optional accessories
10.2.7.1 Chemical and biological indicators
Package to validate VPHP cycles including:

• pack of 100 Biological Indicators (BI)
• pack of 100 Broth culture.
• pack of 100 Chemical Indicators (CI)
It might be required the use of multiple packs to run Cycle Development and PQ.
INFORMATION
Biological Indicator = Unit containing microorganisms with a concentration and resistance that are
known and certified. Geobacillus Stearothermophilus (ATCC 12980 or 7953) is used for VPHP
cycling validation, usually with a population greater than 106. They are placed directly inside the
chamber at the most critical points to reach with the vapour and serve as proof of the efficiency of the
sterilisation process.
Cultural Edge = Means where BI is grown after decontamination to verify its microbiological
inactivation.
Chemical Indicators = They are placed directly inside the chamber at the most critical points and serve
as proof of a good and homogeneous vapour distribution through visual inspection.
INFORMATION
In order to be able to use an isolator in an aseptic process, all the internal surfaces, all the tools and
the material brought into the chamber must be decontaminated. Verification of a correct sterilisation
cycle is carried out by using a sufficient number of CI and BI, which are then used as a statistical test of
the proper distribution of the vapour and its effectiveness.
10.2.8 VPHP generator technical data
VPHP generator weight kg 300

External dimensions mm 480 x 858 x 1322 (l x w x h)
Flow rate m /h
3
from 30 to 70
Tank capacity H2O2 L 2
Disinfectant type H2O2 hydrogen peroxide 30-35%
Injection speed g/min from 1 to 18
Pre-conditioning system absorption rotor with self-regeneration
Dual phase
Catalyst
(Platinum/Aluminium Oxide or Iron Oxide)
VPHP Connections mm Clamp 1.5”
Regeneration air connection mm Clamp 2.5”
≥90 m3/h
Regeneration air
hot and humid air
Absorbed current A 12
Pag. 134/176
10.2.8.1 Required supplies and connections
For Europe
& similar
For North
Main power supply America & 208/120V (2Ph+N+PE(GND)) | 60Hz | 15A
similar
CAUTION
The final user must ensure the following:
· all the supplies of power/energy must be stable and compliant with values defined in the present
manual;
· the electrical supplies must be provided within the ranges defined by the applicable standards (as
example, par. 4.3 of EN 60204-1 (IEC 60204-1) and NFPA 79);
· cycles of switch-off and switch-on of short duration and/or repeated at short intervals must be
avoided;
Failure to observe the specifications above may cause malfunctions and damages.
The Comecer VPHP GENERATOR must be used to sterilise only isolated and closed environments.
Features of the environments to be decontaminated:
• volume up to 10m3
• made with compatible VPHP materials
• no electric device inside (if not explicitly designed for decontamination cycles with VPHP)
• no open chemical product inside
• qualified as “sealed” (reference ISO 10648-2)
Features of the sterilising agent:
• hydrogen peroxide solution at 30% or 35% (stored in the fridge and protected from light)
10.2.9 Area of use
The equipment is designed in order to be used within a pharmaceutical environment or similar. This means it is assumed
the equipment is protected from open air weather conditions and is used within enclosed rooms such as laboratories or
technical areas, with appropriate management of cleanness and the environmental parameters.
It is assumed that no liquid or dusty contaminants are present in the environment, for example suspended powdres, mists,
aerosols and similar.
The equipment is designed to be used between ambient air temperatures of 10°C and 30°C and relative humidity between
30% and 70% (noncondensing).
The maximum design altitude is 1000 m above sea level.
The equipment must be used in an ambient with suitable light conditions to ensure health and safety for operators, both in
normal use and during maintenance, considering light levels, light sources position and orientation, glares or other.
The equipment is not designed to be used in areas with significant vibration, shock and bump.
The equipment is not designed to be used in areas with potentially explosive and/or flammable atmospheres.
Pag. 135/176
10.3 SAFETY AND DAMAGE PREVENTION
10.3.1 Pictograms
10.3.1.1 Safety and information signs
Equipment identification plate.
Danger - High voltage
Danger of burns
Danger of corrosions or chemical burns
It is compulsory to read the manual carefully and to use PPE
Pag. 136/176
10.3.1.2 Position of signs
Make sure that the signs are legible; otherwise, clean them or replace them, setting them in their original place.
A B
Pag. 137/176
10.3.2 Residual risks - Obligations - Prohibitions
10.3.2.1 Ergonomic danger
When using the equipment, the operator may be exposed to risks of an ergonomic nature, such as: overloading or unsuitable
positions.
We recommend assessing the ergonomic risk in relation to the actual work tasks performed by the operator using the
COMECER equipment.
DANGER
Danger of overloading the upper limbs and/or musculoskeletal disorders.
Before using the equipment, assess the ergonomic risk.
Work procedures and/or postures other than those indicated by COMECER may increase the risk factor.
10.3.2.2 Danger of corrosions or chemical burns
The disinfectant used in the VPHP Generator is a 30% to 35%

solution of hydrogen peroxide.
DANGER
A hydrogen peroxide solution from 30% to 35% can cause chemical burns if it comes into contact with
the skin.
There is the risk of fire in contact with flammable substances.
ATTENTION
Attention must be paid to enclosed information sheets for security risks.
ATTENTION
For safety purposes, all of the liquid inside the gas generator must be treated with reasonable care as
if it were H2O2 (hydrogen peroxide) at the liquid status.
10.3.2.3 Danger of burns
During the processing phases, the vaporizer reaches high

temperatures, which means that it is likely to cause burns if
touched by hand.
Pag. 138/176
10.3.2.4 Gas leak hazard
The system is equipped with a Dräger sensor to detect hydrogen peroxide leaks nearby.
INFORMATION
DANGER
ATTENTION
If one of the sensors installed by COMECER detects VPHP (Vapor Phase Hydrogen Peroxide) leaks, the
equipment will automatically activate the air extraction cycle.
ATTENTION
of the risk.
In addition to the sensors supplied with the equipment and/or generator, the final user is authorised to install further sensors
inside the laboratory to enhance safety and to prevent the dangers caused by leakage of VPHP (Vapor Phase Hydrogen
Peroxide).
To install the aforesaid additional sensors, please refer to the qualified expert for an assessment of the most suitable position.
INFORMATION
The installation of other safety sensors for H2O2 in the laboratory is the customer’s responsibility.
ATTENTION
In case of VPHP (Vapor Phase Hydrogen Peroxide) leaks signalled by the laboratory sensors installed
by the customer, immediately stop the generator by pressing the emergency button and proceed
of the risk.
Pag. 139/176
10.3.2.5 Dangers resulting from the use of chemical agents
While using the system, the operator could be exposed to the risk of falling due to possible liquid leakage on the floor.
DANGER
It is forbidden to use the equipment if it causes VPHP (Vapor Phase Hydrogen Peroxide) to be released
into the environment where other people may come into contact with it or inhale it.
In case of liquid leaks in the laboratory, treat them as if they were H2O2 (hydrogen peroxide) in the
liquid status.
ATTENTION
H2O2 (hydrogen peroxide) is corrosive and can cause permanent damage to eyes and burns.
May be fatal if inhaled.
H2O2 (hydrogen peroxide) is not flammable, but the oxygen released when it is broken down may
sustain combustion. Extinguishing Media: water
Use PPE, do not use contaminated clothing and wash hands before touching other objects, especially
food or drink;
Check the expiry date of the peroxide before use. Do not use products that have expired.
INFORMATION
In case of leaks, dilute with water (at least 20 parts of water to one part peroxide, prior to recovery,
using PPE).
10.3.2.6 Residual risks for handling
Before handling the equipment, make sure that the brakes of the swivel wheels are properly released.
Be careful not to leave any objects along the path established for passage of the equipment.
Always use the relevant handles to move the equipment, making sure that your hands or those of any collaborators in the
vicinity are not crushed accidentally.
Move the equipment slowly as it is very heavy and it could be difficult to stop it immediately, if required.
DANGERS
While moving the equipment, be careful not to place your foot in front of its wheels.
Accidental crushing could damage the operator’s lower limbs.
10.3.2.7 Residual risk of tripping
Once the equipment has been positioned, make sure that the castor wheels are
turned inwards to avoid the risk of the operator tripping over them.
Pag. 140/176
10.3.2.8 Mandatory use of PPE (personal protective equipment)
It is mandatory to wear appropriate PPE (Personal Protective

Equipment), such as safety goggles, gloves, shoes, mask
and protective clothing for maintenance operations, such
as changing the kit or the filter and filling up the peroxide
container.
10.3.2.9 Mandatory safety shoes use
During machinery movement or any of its parts inside the

laboratory, safety shoes must be used.
10.3.2.10 Prohibitions
It is forbidden to:
- Remove or tamper with any type of protection or safety
device supplied with the machinery;
- Climb on the machinery
DANGER
The failure to observe the prohibitions in this chapter can cause severe damage to the equipment and
at the same time put the operator and people in the surrounding area at great risk.
Pag. 141/176
10.4 HANDLING AND INSTALLATION INSTRUCTIONS
ATTENTION
During all handling and installation operations, it is mandatory to comply with the relevant standards
in force regarding safety in the workplace.
ATTENTION
COMECER declines all liability for damage caused by incorrect operations, operations performed by
unqualified personnel or use of unsuitable means.
10.4.1 Hose connections
The system is placed on a fixed frame, equipped with wheels to facilitate maintenance. It can be placed in the laboratory or
inside the technical cabinet.
ATTENTION
For safe decontamination, the chamber to be decontaminated and the connections between the
chamber and the generator must be sealed.
Connections are at the top of the equipment.

For safety reasons and for proper operation, connections must not be interchanged.
The entrance has a female flange and the exit has a male flange. The hoses have the counterparts.
ATTENTION
It is important to lock the flanges to prevent possible escape of H2O2 hydrogen peroxide.
If the VPHP generator is not in operation and is separated from the hoses, e.g. for transport, protected caps must be inserted
on the flanges.
Pag. 142/176
10.4.2 Managing incoming and outgoing enabling signals to the equipment
CAUTION
Connection between COMECER electrical wiring and other devices for sending and/or receiving
enabling signals must be carried out by an authorised technician. Before proceeding with any
operation, contact Comecer.
ATTENTION
Input and output signals are available to the Customer.
The Customer is responsible for managing the consent signals correctly to secure the operators and
the workplaces.
The machine is designed for sending enabling signals to customer as per wiring diagrams enclosed.
The enabling signals the machine is located inside the electrical panel.
They are:
• Signal on the operating status of the generator.
INFORMATION
The equipment is designed for receiving enabling signals from the customer as per wiring diagrams enclosed.
The enabling signals of the equipment are located inside the electrical panel.
They are:
• Signals coming from external safety devices, e.g. hydrogen peroxide (H2O2) sensors installed by Customer in the
laboratory
INFORMATION
10.4.3 Connection to the energy sources
10.4.3.1 Power supply
For Europe
& similar
For North
Main power supply America & 208/120V (2Ph+N+PE(GND)) | 60Hz | 15A
similar
INFORMATION
The final user must have a power cable that is long enough to allow the generator to be moved away
from its working position in order for maintenance to be carried out.
Pag. 143/176
10.5 PRECISION ADJUSTMENTS AND SET-UP
When installed, the machine is fully adjusted and does not require any further adjustments.
ATTENTION
Do not edit the parameters set by Comecer technicians.
Incorrect settings can cause the equipment to malfunction, with consequent risks for the operator.
If necessary, request COMECER after-sales assistance for any adjustments or regulations not included
in this chapter.
10.6 OPERATING STANDARDS
10.6.1 Operator position
The following illustration shows the positions that the operator must be in during the work cycle, for his own safety.
Key:
1) Operator’s normal position
2) Operator’s position during maintenance operations
Pag. 144/176
10.6.2 Description of control panels, commands and indicator lights
10.6.2.1 Operator maintenance manual - Optional
The VPHP generator can be equipped with an operator panel for maintenance
and for the modification of operating parameters.
The navigation pages are an extract of the operator panel of the equipment to
which it is connected.
In case the optional control panel is provided, the generator is equipped with a coded key. The key enables the control panel
on the generator (maintenance) or on the equipment to which it is connected (normal operation).
ATTENTION
Key management is delegated to the SOP (Standard Operating Procedure) of the customer.
The keys will be delivered only to qualified personnel and previously informed.
CAUTION
Make sure that the keys supplied are not left unattended.
User levels
There are four user levels:
• Users: Basic use of the equipment;
• Maintenance: User Authorisations + Equipment parameter changes;
• Administrator: Maintenance Authorisations+ Creation of users.
• Comecer Administrator: Administrator Authorisation + Changes to “Setup” page.
INFORMATION
ATTENTION
level access.
ATTENTION
Pag. 145/176
10.6.2.2 Data transfer
Critical data can be exported according to the following modes:

1- standard: USB port at the front of the equipment.
2- on request: Ethernet connection from PLC for transferring instantaneous values; the reception and storage of these values
must be carried out from the customer’s system (PC, SCADA, etc.).
As for the second mode, Comecer can provide:
• PLC Ethernet connection (switch ETH)
• Software export data
• Documents with data interconnection specifications.
Comecer does not supply:
• Ethernet cable
• Data acquisition external system
Data transfer mode lay-out
ETHERNET cable
USB cable
B
PLC
C
HMI
D
E
A
F
1 2
Ref. Description
A USB key (not supplied)
B USP port
C HMI internal memory
D Ethernet Port on PLC
E Switch ETH
F External Computer (responsibility of the customer)
Pag. 146/176
10.6.3 Normal start-up
The isolator and the VPHP generator are equipped with independent power supplies and each has its own electrical switch.
To power both pieces of equipment:
ON
To power the equipment, turn the electrical switch to “ON”.
ON
Make sure that the electrical maintenance switch for the VPHP generator is set
to “ON”.
Pag. 147/176
10.6.4 Normal stop
Through the operator panel stop the sterilization cycle if any, and bring the equipment in stand-by condition
To cut off power to both pieces of equipment:
To disconnect the equipment, turn the electrical switch to “OFF”. OFF
INFORMATION
actuation.
OFF
For maintenance operations on the VPHP generator, it is possible to proceed
with local disconnection by means of the relative on-board electrical switch.
Pag. 148/176
10.6.5 Emergency stop
There could be an emergency button on the front casing making it possible

to safely block the sterilization cycle by stopping the production of VPHP (the
heating plate and the peristaltic pump are stopped); the internal fans continue
to work anyway for a rapid disposal of VPHP present in dedicated circuits.
ATTENTION
The emergency button must not be used to stop the equipment under normal circumstances.
The improper use of this device can cause malfunctioning.
Pag. 149/176
10.6.6 Using the equipment
INFORMATION
The VPHP generator is controlled from the operator panel of the equipment which it is connected to -
for more information see the attached operator panel manual.
10.6.6.1 Container with hydrogen peroxide solution
A 2.0 litre container with 30% to 35% of H2O2 (hydrogen peroxide) solution is located behind the front door.
At the beginning of the cycle, the generator automatically checks if there is enough hydrogen peroxide solution in the vial.
The consumption can be calculated by knowing the decontamination period and the dosage rate.
If the content of the vial is insufficient for a complete cycle, a fault-message will be shown on the display.
The system cannot be started before the vial has not been refilled sufficiently with hydrogen peroxide solution.
10.6.6.2 Pump tract kit assembly
To assemble the pump tract kit, proceed as follows:
Open the front door (Ref.1). 1
2 3
Open the pump access door (Ref.2)

Position the section of the pipe (Ref.3) on the rotating head of the pump
Close the pump door back up again
Pag. 150/176
10.6.6.3 Dispensing pipes kit assembly
To assemble the dispensing kit, proceed as follows:
Connect the two PVC pipes with LL fittings (Ref. A), to the two quick-fit connections located on the lids of the containers.
Unscrew the ring nuts from the fittings, place the pipes in the ring nuts and fit them onto the quick couplings, then screw the
ring nuts back on the fittings to lock the pipes on.
Connect the pipe without terminals (Ref. B) to the quick coupling fittings located on the lids of the containers.
Unscrew the ring nuts from the fittings, place the ends of the pipe in the ring nuts and fit them onto the quick couplings,
then screw the ring nuts back on the fittings to lock the pipes on.
Connect the three pipes with female Luer lock terminals (Ref. C).
C
C
C
B
A
A
Pag. 151/176
10.6.6.4 Dräger sensor start-up
At every equipment start-up, the Dräger detection sensor requires a polarisation time, before which it is not possible to
execute sampling.
The time is indicated on the instrument display and can vary depending on the time elapsed from the last use and type of
sensor installed (usually 30 minutes for Dräger sensor).
If the display cannot be seen, comply with the nominal values indicated in the sensor data sheet.
It is prohibited to start decontamination cycles before the time required for the sensor to heat up.
WARNING
Before using the sensor, wait for the time necessary for warming up.
INFORMATION
For more information, consult the manual and the Dräger sensor calibration procedure, supplied as
an attachment.
Pag. 152/176
10.6.6.5 Activation of Dräger sensor
The Dräger sensor is activated if there is a leak of VPHP from the generator or from the equipment it is connected to.
In this case:
• The Dräger sensor detects the presence of >1 ppm VPHP and triggers the alarm system;
• The production of VPHP is stopped (the alarm causes the peristaltic pump and the heating plate to be turned off
automatically);
• The emergency procedure for VPHP elimination starts automatically: The generator fans remain in operation and the
ventilation of the equipment is switched on for full extraction in order to eliminate VPHP from the extraction ducts;
• The laboratory must be made safe (all personnel present must leave the laboratory in accordance with the in-house
emergency procedures);
• Only trained personnel and experienced in the management of VPHP may have access to the laboratory, and only with
the use of PPE (mask, gloves, goggles, shoes and protective clothes);
• Staff may access the laboratory only when the Dräger sensor no longer reports a state of alarm. Personnel not trained and
inexperienced must not access the lab as long as the Dräger signals an alarm state;
• The customer must contact Comecer for the solution to eventual damage to the generator (failure of the leak test
performed after the equipment reset) or if the Dräger sensor continues to signal an alarm and safe conditions are not
restored in proper time.
ATTENTION
Only personnel trained and experienced in the management of VPHP (Vapor Phase Hydrogen Peroxide)
may have access to the laboratory in alarm state, and only with the use of PPE (mask, gloves, goggles,
shoes and protective clothes).
INFORMATION
Normal use of the generator includes the leak test before starting a new cycle of VPHP (Vapor Phase
Hydrogen Peroxide), to assess the effective resolution of the fault.
Pag. 153/176
10.6.6.6 Select chambers to be decontaminated
A distribution system integrated to the equipment makes it possible to choose the chamber to be decontaminated.
VPHP inlet
Generator Main 1
VPHP outlet
Pre 1
VPHP Main 2
distribution Auto
on/off
Flow
regulation
10.6.6.7 Sterilisation start
INFORMATION
The VPHP generator is connected to the corresponding machine.
Pag. 154/176
10.6.7 Operational functioning
Decontamination takes place through four distinct phases: the duration of each phase can be calculated and used as the
starting point to validate the cycle. The calculated times must be used as a starting guide since some hypothesis may not be
valid for all configurations.
The Comecer VPHP Generator work phases are:
• Dehumidification
• Conditioning
• Decontamination
• Ventilation
• .Phase 1 - Dehumidification Initial conditions required for decontamination are created in the chamber, adjusting the
relative humidity in order to reach a value that will be the standard for injecting hydrogen peroxide safely and to ensure
reproducibility of the cycle in future.
• Phase 2 - Conditioning: During this stage, the required concentration of hydrogen peroxide (H2O2) within the chamber,
necessary to ensure the killing effect, is reached. The goal at this stage is to get the most concentration of H2O2 possible
within the chamber, in the shortest time possible, rapidly reaching the level of bacterial reduction. The main parameters
to consider in this stage are: Dosing of liquid hydrogen peroxide (g/min), which is injected into the chamber, and the air
intake speed in the chamber (m/s).
• Stage 3 - Decontamination in this phase, within the chamber, the concentration of H2O2 is kept stable at the value
achieved during the conditioning phase for all the time necessary to reach the desired SAL value (usually SAL=10-6).
Therefore, the main parameters to consider at this stage are the dosage of liquid hydrogen peroxide (g/min) and the
duration of the same step (min). The effect of this stage is to maintain the stability of the bacterial reduction rate.
• Stage 4 - Ventilation: in this stage an H2O2 concentration is reached that ensures the safety of the personnel before
opening the chamber (also known as the Threshold Limit Value (TLV) and generally corresponding to H2O2 =1ppm)
and does not go to alter the quality of the tests and/or processes that need to be performed in the chamber. The main
parameter to consider at this stage is the duration of the phase itself (min). At this stage, a further phase of ventilation
(Stage 5) is usually followed by the equipment to be decontaminated to speed up the time at which the limit is reached.
Pag. 155/176
10.6.8 Generator status
INFORMATION
The VPHP generator is connected to the corresponding machine.
For further information, please refer to chapter “Equipment Status” in this manual
Pag. 156/176
10.7 MAINTENANCE
CAUTION
All the maintenance interventions not included in this chapter are to be performed by an authorised
COMECER technician.
ATTENTION
Before performing maintenance on the VPHP (Vapor Phase Hydrogen Peroxide) generator, make sure
there is no volatile H2O2 (hydrogen peroxide), using a portable sensor (not supplied by Comecer).
10.7.1 Warnings regarding maintenance
Production managers and operators in charge of maintenance must comply with all the prescriptions issued by the Safety
Bodies when carrying out the specific operations listed in this chapter.
Maintenance, cleaning and removal of equipment components and devices must only be carried out by specialists.
It is good practice to use only original spare parts for repairs to ensure the safe operation of the equipment. Should additional
instructions be required or particular problems arise, do not hesitate to contact the manufacturer. To prevent malfunctions
that could directly or indirectly create serious accidents, injuries to persons and damage to materials, it is important to
comply with all instructions described on the equipment, on the layouts and in this document.
Make sure that the tools available are suitable for use; prevent any misuse of the tools or equipment.
10.7.1.1 General information
Maintenance must only be performed by the following persons:

A. operator who performs general inspections and cleaning operations;
B. maintenance technician who performs adjustments and replaces parts;
C. manufacturer’s after-sales assistance who performs special maintenance (COMECER).
10.7.1.2 Precautions and setting the machine in maintenance mode
The maintenance personnel must be aware that maintenance operations can pose risks. It is therefore necessary to respect
all instructions found in this use and maintenance manual starting from general instructions concerning the preparation of
the equipment for maintenance.
It is of fundamental importance:
A. To avoid any physical contact with the moving parts;
B. Unskilled and unauthorised personnel cannot access the work area when the equipment is under maintenance;
C. The maintenance operations that require the presence of electric power, such as troubleshooting in the electric
boxes, must be carried out only by authorised personnel, who must follow the safety procedures in force within the
establishment;
D. Maintenance operations above 2 m from the ground are carried out using suitable and standard means (ladder, helmet,
etc.);
E. Use the required personal protective devices are used;
F. All equipment maintenance operations must be carried out:
F.1 Only in the absence of electric/pneumatic power based on the type of intervention.
F.2 When the area is well lit. In case of maintenance in areas that are not sufficiently lit, use portable lighting devices
and avoid cones of shade that could hinder or reduce visibility in the area of operation or in the surrounding areas
Pag. 157/176
10.7.2 Isolating the machine from energy sources
The equipment requires connection to different energy sources. Based on the maintenance operation to be carried out, it
may be necessary to isolate the equipment from one or more energy sources, according to the instructions provided in this
manual.
ATTENTION
Prior to carrying out any maintenance job, carefully read the instructions contained in the manual.
10.7.2.1 Electrical supply sectioning
OFF
To disconnect the VPHP generator, turn the electrical switch to “OFF”.
Pag. 158/176
10.7.2.2 Locking device for maintenance
The devices used to cut out power installed on the equipment and described in this instructions manual were designed to
allow the insertion of lockout and tagout devices in the “safe” or “off” position.
The images provided here below are application examples of such devices.
The Lockout-Tagout (LOTO) procedures must be provided for by the employer.
These procedures must indicate the location of the lockout (tagout) device in each power cut-out device, so that the latter
and the controlled equipment cannot be used until the lockout has not been removed.
The lockout and tagout devices must be applied to the individual power cut-out devices by authorised personnel
(maintenance technicians).
DANGER
Lockout devices and tagout devices provided by the employer shall be suitable for the purpose (e.g.
shall be singularly identified, shall be capable of withstanding the environment to which are exposed,
shall be standardized within the facility, shall be substantial enough to prevent inadvertent or
accidental removal, shall indicate the identity of the employee applying the device(s), etc.).
1 2
Pag. 159/176
10.7.2.3 Dissipation of residual energies
After isolating the equipment, the maintenance technician has to make sure there are no risks deriving from residual energy
(e.g., pressurised circuits, condensers, inertias and suspended loads, hot parts, etc.).
For this aspect, please refer to the paragraph on residual risks of this manual
If necessary, prior to proceeding the maintenance technician must wait for this residual energy to be discharged or arrange
for discharging it directly (for example, by discharging the pressure according to the instructions found in the pneumatic
diagram).
10.7.2.4 Verification of the safe state (isolation)
Prior to starting work on machines or equipment that have been locked out or tagged out, the authorized employee shall
verify that isolation and deenergization of the machine or equipment have been accomplished.
10.7.2.5 Release from lockout or tagout
Before lockout or tagout devices are removed and energy is restored to the machine or equipment, procedures shall be
followed and actions taken by the authorized employee(s) to ensure that:
• The work area shall be inspected to ensure that nonessential items have been removed and to ensure that machine or
equipment components are operationally intact;
• The work area shall be checked to ensure that all employees have been safely positioned or removed.
10.7.2.6 Temporary removal of the Lock-out devices
If the Lock-out devices must be temporarily removed to verify equipment or system operation and then applied once again,
it is important to:
1) Move materials and instruments used away from the equipment and/or system;
2) Check that all personnel is in safe position, away from any moving and/or live parts when the equipment and/or system
are re-activated;
3) Remove the lock-out devices.
4) Re-power and check equipment and/or system operation.
5) Isolate the power sources.
6) Re-apply the lock-out devices.
7) Continue with maintenance activities.
10.7.2.7 Interventions over several work shifts
If maintenance extends over several work shifts, the work supervisor, who applied the Lock-out procedure in the first place,
during his shift, must transfer the responsibility of the procedure to the supervisor of the incoming shift. The latter must then
place his own lock-out device on the isolating/disconnection devices and update the relative personnel and the incoming
personnel. This procedure must always be implemented every time there are shift changes and/or the assigned or relative
personnel changes.
Pag. 160/176
10.7.3 Periodic checks
ATTENTION
COMECER declines all liability due to lack of maintenance of the equipment, as shown in the table of
periodic inspections.
10.7.3.1 Every day and before starting the processing cycle

Check the level of peroxide in the calibration container and empty it every time the dispensing
Operator
container is filled.
Check the hydrogen peroxide level in the container and fill it if necessary Operator
Clean stainless steel surfaces. Remove all hydrogen peoxide splashes Maintenance technician
Make sure that the external connection hoses are connected firmly to the feeding hose Maintenance technician
10.7.3.2 Every month

Check the sealing of all inner hoses: Perform a leak test from the equipment operator panel,
including also the VPHP generator. Maintenance Technician
For more information see the operator panel manual.
Visually check for damage or corrosion Maintenance technician
Visually inspect the conditions of the VPHP collection container Maintenance technician
10.7.3.3 Every three months

Clean the dehumidifier air inlet filter (Ref. P&ID - FA103) Maintenance Technician
Visually check the inner connections hoses Maintenance technician
Clean the electrical panel filter Maintenance technician
10.7.3.4 Every six months

Visually inspect the conditions of the evaporation plate. Maintenance technician
Check all alarms. If necessary, adjust the thresholds. Maintenance technician
Check for proper operation of the emergency button . Maintenance technician
Check the scale for hydrogen peroxide (Ref. P&ID - WT301). If necessary, re-calibrate it.
Comecer
Check and calibrate the Drager sensor for VPHP (P & ID - AT900 / AE900)
Comecer
Pag. 161/176
10.7.3.5 Every 1000 hours of operation, and in any case, every year

Replace the absolute filter (Ref. P&ID - FA103) Maintenance technician
10.7.3.6 Yearly or as indicated in the user manuals of the instruments

Check proper operation and/or calibration of: Dehumidifier (Ref. P&ID - EQP201), Temperature/
humidity transmitter (Ref. P&ID - MTT102 and MTT103), Disk calibrated for regeneration air
Comecer
(Ref. P&ID - FO 103 and FO 201).
10.7.3.7 Every year

Replace the kits Maintenance Technician
Check all safety fuses and relays. Maintenance technician
Check the input and output cards Maintenance technician
Check the HEPA filter by means of the DOP test. Replace it, if required. Maintenance technician
Check the accuracy of the dosing pump for dispensing hydrogen peroxide Maintenance technician
Check the internal cleaning of the heater and remove any dirt deposits. Remove the limescale
Maintenance Technician
deposits on the evaporation plate.
Check the fans (M 101, M 102, M 201). Maintenance Technician
Check electric connections
Comecer
Check the heating elements in the hydrogen peroxide solution evaporation chamber. Replace
Comecer
them, if required.
Replace the dispensing nozzles Comecer
Check if there are residues within the inner and outer hoses. If necessary, replace the hoses. Comecer
Contact Comecer for routine maintenance. Comecer
10.7.3.8 Every two year

Replace the catalyzer Maintenance technician
Replace solenoid valve 3/2 (Ref. P&ID - XV301) Comecer
10.7.3.9 Every five years

Replace the inner and outer hoses Comecer
Pag. 162/176
10.7.4 Descriptions of additional periodic controls
10.7.4.1 Filter integrity testing - DOP test
Connect a photometer (not provided by COMECER) to the “UP STREAM” and “DOWN STREAM” lines.
With ventilation on: remove the cap below and introduce the smoke concentration inside the fan.
Close the cap.
If the value detected by the photometer is lower compared to the preset value, it has passed the test.
If the value detected by the photometer is higher compared to the preset value, it has failed the test and the filter should be
replaced.
Pag. 163/176
10.7.5 Calibration of peristaltic pump
Calibrate the pump using the specific function on the machine’s operator panel (for more information refer to the software
manual).
10.7.6 Calibration of the Drager sensor
ATTENTION
As specified in the periodic checks table, the calibration frequency is indicative and may vary
depending on different parameters, such as humidity, pressure, room temperature, and/or type of gas
with which the sensor comes into contact.
In order to set the most appropriate calibration frequency for the specific application, a more frequent calibration (every
month) is recommended for the first six months of use of the device, noting the difference between calibrations.
For calibration, refer to the specific attachment, and for more detail consult the Drager transmitter manual.
Contact Comecer to purchase a special calibration kit of for direct calibration of the product.
In order to calibrate high concentration sensor, it is highly recommended to request assistance from a specialised technician,
and the use of suitable materials (extractor hoods, PPI, etc.)
Contact Comecer for more details.
WARNING
Before calibrating, check that the sensor support filter does not contain drops of liquid or humidity.
This could signify that the sensor is worn and needs replacing.
WARNING
The use of worn, old or not calibrated sensors can cause criticality for processes inside the machinery
and for operator safety.
COMECER declines any responsibility caused by the use of worn sensors or sensors that have not been
suitably calibrated according to indications.
INFORMATION
For more information, consult the manual and the Dräger sensor calibration procedure, supplied as
an attachment.
Pag. 164/176
10.7.7 Replacement procedures
INFORMATION
At the end of the operation, restart the machine and wait a few seconds so that optimal conditions of
the chambers can be re-established.
Make sure there are no other alarms left.
10.7.7.1 Absolute filter replacement
Pag. 165/176
Proceed as described below to replace the absolute filter:
DANGER
2
Open the clamp flange (Ref.2) and remove the cap (Ref.3).
4
Unscrew and remove the filter (Ref. 4).
Replace the filter.
Pag. 166/176
10.7.7.2 Replacement of the H2O2 container
Proceed as described below to replace the container:
2 3
Disconnect the quick connectors (Ref.2) and (Ref.3) from the cover of the
container.
Follow the steps for filling the container, whilst working in a protected area with
the suction hood turned on.
Pag. 167/176
10.7.7.3 Dispensing pipes kit replacement
To replace the dispensing kit pipes, proceed as follows:
Disconnect the three pipes (Ref.C).

Disconnect the pipe without terminals (Ref. B) from the quick coupling fittings located on the lids of the containers.
Loosen the ring nuts from the fittings and remove the end of the pipe.
Disconnect the two pipes (Ref. A) from the two quick-fit connections located on the lids of the containers.
Unscrew the ring nuts from the connections and remove the pipes.
C
C
C
B
A
A
Pag. 168/176
Replace the pipes.
Reassemble all parts following the instructions at chapter “Dispensing Kit Installation”.
Pag. 169/176
10.7.7.4 Pump tract kit replacement
To replace the pump hose, proceed as follows:
2 3
Open the pump access door (Ref.2)

Remove the section of hose (Ref.3)
3 4
Unscrew the connections (Ref. 4) of the section of pipe (Ref. 3)

Replace the pipe section with a new one
INFORMATION
Comecer recommends that after each replacement of the pump kit is performed calibration of the
peristaltic pump.
See paragraph “Pump Calibration” and the machine software manual for more information.
Replace the pipe.
Reassemble all parts following, in reverse order, the instructions at chapter “Pump Tract Kit Installation”.
Pag. 170/176
10.7.7.5 Liquid collection container verification and emptying
Check the container for collection of washing liquids and/or possible leakage. If it has to be emptied, proceed as
follows:
Open the side door (Ref.1). 1
2 3
Disconnect the VPHP collection hoses (Ref. 2).

Remove the container (Ref. 3) from its seat.
Empty it following the safety procedures and environmental regulations in the
country of use.
Pag. 171/176
10.8 ATTACHMENTS

• Operator Panel Manual (attached separately)
• Specific manuals for the installed components (attached separately)
This manual is completed with additional attached documentation, especially the strict requirement to use the product
correctly and safely:
• List of spare parts (attached separately)
• Wiring diagram (attached separately)
• P&ID (attached separately)
Pag. 172/176
©2019 COMECER S.P.A. | ALL RIGHTS RESERVED - TUTTI I DIRITTI RISERVATI
Via Maestri del Lavoro, 90 - 48014 Castel Bolognese (RA) Italy
http://www.comecer.com - E-mail: comecer@comecer.com
tel. (+39) 0546 656375 - fax (+39) 0546 656353
Part of COMECERGROUP

1.4 Um Sterility-Isolator-Vphp-generator v18413 r1 Eng

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STERILITY ISOLATOR

MODULAR ISOLATOR FOR

Use and maintenance manual

Rev. Reason for revision Revision date

3 SAFETY AND DAMAGE PREVENTION................................................................................................................................... 49

4 HANDLING AND INSTALLATION INSTRUCTIONS.............................................................................................................. 57

5 PRECISION ADJUSTMENTS AND SET-UP............................................................................................................................ 65

8 DEMOLITION AND DISPOSAL.............................................................................................................................................. 115

10 ATTACHMENT: VPHP GENERATOR USE & MAINTENANCE MANUAL........................................................................... 119

10.4 HANDLING AND INSTALLATION INSTRUCTIONS.........................................................................................................................142

10.7.4 DESCRIPTIONS OF ADDITIONAL PERIODIC CONTROLS.....................................................................................................163

1.1 PURPOSE OF THE MANUAL

This manual is an integral and essential part of the equipment.

1.1.1 Graphic warning conventions

1.2.1 Operators for whom this manual is intended

MECHANICAL MAINTENANCE TECHNICIANS: Technicians trained and authorised to perform routine

1.3 WARRANTY AND EXCLUSION OF LIABILITY

1.4 REQUESTING TECHNICAL ASSISTANCE

1.5 MANUFACTURER AND MACHINE IDENTIFICATION DATA

The manufacturer’s and equipment’s identifying details are printed on a label:

1.6 REFERENCE STANDARDS

This product is manufactured in compliance with the following EU Directives:

2.1 GENERAL INFORMATION

2.1.1 Main groups

Prechamber material insertion

Technical compartment for liquid waste extraction

VPHP generator compartment

2.2 OVERVIEW OF THE MAIN COMPONENTS

2.2.1 Front view

Ref. Description Ref. Description

12 Pre chamber front door 25 Liquid waste disposal container

13 Lower technical compartment 26 Container movement trolley

2.2.2 Rear view

Ref. Description Ref. Description

8 VPHP recirculation pump compartement

2.2.3 Internal view

2.3 OVERALL DIMENSIONS

2.4 DESCRIPTION OF THE EQUIPMENT

2.4.1 Construction features

2.4.1.2 Air tight system

An inflatable gasket system, along the perimeter of the openings, guarantees

All inflatable gaskets of the doors are made of Bio-Guardian® silicone.

2.4.2.1 Position of the filters

Ref. Description Function

2.4.2.2 Ventilation system diagram

Decontamination can be actuated in different ways:

2.4.3.1 Decontamination system diagram

During the aeration phase (concentration of H2O2 within the

Ref. Description Ref. Description

1 Liquid waste container

Manual ball valve D Microbiological impactor setup

GVPHP VPHP generator

Three-way automatic valve H2O2 low-concentration detection sensor

IA Air inlet from laboratory

2.4.3.2 Vaporized hydrogen peroxide generator

2.4.4 Quality of the air

2.4.4.1 Main chamber

Ref. Description Function

LED Lamp Main chamber lighting

LED Lamp Pre-chamber lighting

2.4.6 Electrical and pneumatic panels layout

Electronic control panel

Pneumatic line arrival air handling unit

Secondary pneumatic panel