FHR1-50-LAF

LAMINAR FLOW SHIELDED HOOD FOR HANDLING MEDIUM ACTIVITY

TD_FHR1-50-LAF_R10_ENG – 07/11/19

ISO 9001 & ISO 13485 Certified Quality System

PLEASE NOTE
The total or partial reproduction of this document, using any means, without the permission of
Comecer S.p.A., is forbidden.

PLEASE NOTE
The photos and images provided are purely informative. Consequently, they cannot represent the
type of equipment specifically installed.
 TD_FHR1-50-LAF_R10_ENG – 07/11/19

INDEX

1 OVERVIEW.....................................................................................................................................................................................4
1.1 REFERENCE STANDARDS........................................................................................................................................................................... 4

2 CONSTRUCTIONAL FEATURES..................................................................................................................................................5
2.1 DESCRIPTION OF MAIN COMPONENTS............................................................................................................................................... 5
2.2 SHIEDINGS LAYOUT..................................................................................................................................................................................... 7
2.3 MACHINE STRUCTURE................................................................................................................................................................................ 8
2.3.1 MATERIALS USED................................................................................................................................................................................... 8
2.3.2 STRUCTURE.............................................................................................................................................................................................. 8
2.3.3 SHIELDED CRYSTAL............................................................................................................................................................................... 8
2.4 WORK AREA..................................................................................................................................................................................................... 8
2.5 VENTILATION.................................................................................................................................................................................................. 9

3 TECHNICAL DATA..................................................................................................................................................................... 10
3.1 OVERALL DIMENSIONS.............................................................................................................................................................................11

4 ACCESSORIES............................................................................................................................................................................ 12
4.1 STANDARD SUPPLY....................................................................................................................................................................................12
4.2 ACCESSORY DESCRIPTION .....................................................................................................................................................................12
4.2.1 LED LAMPS FOR LIGHTING..............................................................................................................................................................12
4.2.2 TECHNICAL GAS CONNECTIONS...................................................................................................................................................12
4.2.3 BMI - SHIELDED SLIDING FRONT PROTECTION.......................................................................................................................13

5 CLEANING PROCEDURES........................................................................................................................................................ 14

6 VALIDATIONS - FAT/SAT PROTOCOLS.................................................................................................................................. 15

6.1 MAIN STEPS OF VALIDATION:.................................................................................................................................................................15
6.2 FAT (FACTORY ACCEPTANCE TEST)......................................................................................................................................................15
6.3 SAT (SITE ACCEPTANCE TEST)................................................................................................................................................................16
6.4 OPTIONAL......................................................................................................................................................................................................17
6.4.1 IQ & OQ (INSTALLATION QUALIFICATION & OPERATIONAL QUALIFICATION)............................................................17

7 AFTER-SALES SERVICE............................................................................................................................................................ 18
7.1 MAINTENANCE SERVICES........................................................................................................................................................................18
7.1.1 PREVENTATIVE MAINTENANCE......................................................................................................................................................18
7.1.2 ON CALL MAINTENANCE..................................................................................................................................................................18
7.2 REMOTE ASSISTANCE / HELP DESK......................................................................................................................................................18
7.3 TRAINING & CONSULTING.......................................................................................................................................................................18

8 INSTALLATION REQUIREMENTS............................................................................................................................................ 19
8.1 NOTES REGARDING INSTALLATION.....................................................................................................................................................19

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 TD_FHR1-50-LAF_R10_ENG – 07/11/19

1 OVERVIEW
The FHR1-50-LAF is a radiochemistry shielded hood for manipulations at medium activity with frontal sliding shielding and
shielding of the work area.

1.1 REFERENCE STANDARDS

This product is manufactured in compliance with the following EU Directives:
• Machinery Directive - Directive 2006/42/EC on machinery
• EMC Directive - Directive 2004/108/EC on the approximation of the laws of the Member States relating to electromagnetic
compatibility
And, for what applicable, with the harmonized standards:
• EN ISO 12100:2010 Safety of machinery - General principles for design - Risk assessment and risk reduction
• EN 60204-1:2006 Safety of the machinery - Electrical Equipment of the machine - Part 1: General requirements

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 TD_FHR1-50-LAF_R10_ENG – 07/11/19

2 CONSTRUCTIONAL FEATURES

2.1 DESCRIPTION OF MAIN COMPONENTS

2
5
3

Ref. Description
1 Pneumatic valve air outlet
2 Upper technical compartment (air filtration system)
3 Technical gas valve control
4 Shielded glass window
5 Control panel
6 Lower technical compartment (electrical panel)

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 TD_FHR1-50-LAF_R10_ENG – 07/11/19

1
2 3

6
7

9
8

10

Ref. Description
1 Pneumatic valve air outlet
2 Filter output stage II (activated carbon filter)
3 Filter output stage I (absolute filter)
4 Laminar Flow Fan
5 Laminar flow absolute filter
6 Technical gas connections
7 Anemometer sensor
8 Laminar flow air intake deflector
9 Electric sockets
10 Electrical panel

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 TD_FHR1-50-LAF_R10_ENG – 07/11/19

2.2 SHIEDINGS LAYOUT

B B
1
2
4

SEC. A-A A

4 5

1 SEC. B-B

Thickness
Ref. Description Material
(mm)
1 Rear shielding Pb 50
2 Work bench shielding Pb 50
3 Shielded glass window Lead glass 50*
4 Sliding shielded mobile protection Pb 50
5 Side shielding Pb 50

* Value equivalent to a hypothetical thickness of lead

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 TD_FHR1-50-LAF_R10_ENG – 07/11/19

2.3 MACHINE STRUCTURE

2.3.1 Materials used

Building the machine completely in AISI 304 stainless steel allows for fast removal of external contamination and durability.

2.3.2 Structure

Support 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.

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.

2.3.3 Shielded crystal

High lead content glass (density ≥ 4.8 g/cm3) and is perfectly transparent. The glass is mounted in a shielded frame to
guarantee the continuity of the shielding at the points where it joins the surface of the door.

2.4 WORK AREA

The front opening of the hood is partially covered by two hinged Plexiglas panels that can be opened, moving the mobile
protection, thus allowing for the entire front wall to be open with the exception of the space occupied by the protection
itself.

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 TD_FHR1-50-LAF_R10_ENG – 07/11/19

2.5 VENTILATION
The upper wall contains two absolute HEPA filters (99.995% rms -) (Ref. 3) that cover the entire work area (laminar flow area).
The complete internal space of the hood is continuously washed with an air flow in parallel currents and minimum velocity
gradient (Ref. 4).
The air mass is moved by two fans that recirculate air through the HEPA absolute filters.
The flow is directed downwards in a vertical direction and then returns to the fans through the air plenum.
Air is drawn through a grid on the base of the front hood (Ref. 1), passes under the work bench (key 2) and is introduced into
the working chamber after passing through the HEPA filter.
A small fraction of the air mass (30%) is extracted from the chamber through a fan.
The outgoing air (Ref. 5) is filtered through one absolute filter and one activated carbon filter.
The state of filter clogging is still monitored by pressure gauges equipped with clogging alarm systems on the control panel.

3 5

The particle content in the air complies with the ISO 14644-1 and EEC-cGMP requisites.
For Class A “At rest” (EEC-cGMP III Ed):
• 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 (Class A) in accordance with the EEC-cGMP
Directive: 0.45 m/sec ± 20%.

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 TD_FHR1-50-LAF_R10_ENG – 07/11/19

3 TECHNICAL DATA
Frame material AISI 304 - Scotch-BriteTM
Working chamber material AISI 316L - Mirror-Bright
Electrical panel protection rating IP 54
Lead purity % Pb ≈ 98%+ Sb ≈ 2%
Weight kg 2300
Overall dimensions mm 1500 x 906 x 2925 (l x w x h)
Work area dimensions mm 1294 x 647 x 616 (l x w x h)
For Europe
Main power supply 230V (1Ph+N+PE) | 50/60Hz | 16A TN-S
& similar
For North
Main power supply America & 208/120V (2Ph+N+PE(GRD)) | 60Hz | 15A
similar

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 TD_FHR1-50-LAF_R10_ENG – 07/11/19

3.1 OVERALL DIMENSIONS

200
B

2925 +5-0 MAX OVERALL DIMENSION

A A

2560
616

647

SECTION B-B
B

906 +5-0 MAX OVERALL DIMENSION 1500 +5-0 MAX OVERALL DIMENSION

1294

SEZIONE A-A

1214

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 TD_FHR1-50-LAF_R10_ENG – 07/11/19

4 ACCESSORIES
The machine is provided with a complete supply of accessories

4.1 STANDARD SUPPLY

• LED lamps for lighting
• Filter clogging control pressure gauges
• Three connection lines for technical gases in AISI 316 1/8” steel with on-off ball valves with control hand-wheels that have
a gas identification label
• One connection line for technical gas in AISI 316 6mm steel with on-off ball valves with control hand-wheels that have a
gas identification label
• Protected electrical power supply sockets with external and individual control
• Anemometer for Class A laminar flow chambers
• BMI - Shielded sliding front protection

4.2 ACCESSORY DESCRIPTION

4.2.1 LED lamps for lighting

The entire work area is lit by energy saving LED lamps .

4.2.2 Technical gas connections

Every chamber is equipped with 1/8” (3.175 mm) AISI 316 stainless steel gas
supply line with ball shut-off valves equipped with command handwheels and
a gas identification plate and with one 6 mm AISI 316 stainless steel gas supply
line with ball shut-off valves equipped with a command handwheel and a gas
identification plate.
The respective manual valves, used to control the technical gas passage, are at
the front of the machine.
NOTE: the number of connections can vary according to the configuration of
the machine.

4.2.3 BMI - Shielded sliding front protection

This front protection shielded with lead is specifically designed to protect

operators when they perform manual operations. It is equipped with a shielded
glass window.
When not in use, BMI protection can be placed internally on the side of the front
opening.

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 TD_FHR1-50-LAF_R10_ENG – 07/11/19

5 CLEANING PROCEDURES
The cleaning procedures are an integral part of machine use.
A specific tested and validated kit for cleaning the surfaces of the isolator is a valid help to reduce microbiological
contamination inside the work chamber.
The machine is supplied complete with 1 cleaning kit.

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 TD_FHR1-50-LAF_R10_ENG – 07/11/19

6 VALIDATIONS - FAT/SAT PROTOCOLS

According to the GMP requirements (Good Manufacturing Requirements), each manufacturer has the task to identify the
validation steps which are necessary in order to prove that the critical aspects of his particular operation are under control.

6.1 MAIN STEPS OF VALIDATION:

• URS - User Requirement Specification (by User)
• DQ-Design Qualification (standard supply, can be covered in normal design reviews)
• FAT-Factory Acceptance Test (standard supply)
• SAT-Site Acceptance Test (standard supply)
• IQ-Installation Qualification (optional supply)
• OQ-Operation Qualification (optional supply)
• PQ-Performance Qualification (by User).
Comecer supply FAT (Factory Acceptance Test) validation protocols for every Hot Cell/Dispensing system/Isolator. Comecer
perform SAT (Site Acceptance Test) and supply if requested IQ & OQ protocols (Installation Qualification & Operational
Qualification). The validation protocols comply to the following standards:
• ISO 14644 (Clean-rooms and associated controlled Environments)
• ISO 10648 (Containment enclosures)
• EEC-GMP (Good Manufacturing Practice - Annex 1 Manufacture of sterile Medicinal Products)
• PDA -TR Nr 34 (Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products).

6.2 FAT (FACTORY ACCEPTANCE TEST)

The complete validation test for the equipment will be performed at Comecer’s site. The FAT protocol will include the
following tests:
• Test Instrument Data (Calibration Certificates of the reference instruments)
• System Documentation Verification (documents list for the equipment qualification)
• Construction Design Verification (“As Built drawings and schemes”)
• Main Equipment Specification Verification (correspondence with the design)
• Functionality/Interlocks Verification (Mechanical & Software)
• Glove Breach Test (only where gloves provided)
• Unidirectional Air Flow Verification (Smoke pattern test - only with Laminar flow)
• Air Change Rate
• Air Velocity Verification (only with Laminar flow)
• Filter Leakage (Integrity test)
• Leak tightness Test (only if applicable)
• Non Viable Particle Counts (Air classification).

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 TD_FHR1-50-LAF_R10_ENG – 07/11/19

Fig. 1 Laminar Flow Air Velocity Fig. 2 Filter Leakage Fig. 3 Unidirectional Air Flow Verification
(Smoke pattern test)

Fig. 4 Glove Breach Test Fig. 5 Leak Tightness Test Fig. 6 Particle Counting Test (Air
Classification)

6.3 SAT (SITE ACCEPTANCE TEST)

The SAT will include the following tests:
• Finishing Visual check
• Main components visual check
• Internal box pressure and ventilation setting
• Utilities functionality and setting check
• Functionality/Interlocks Verification (Mechanical & Software)
• Hot test for dispensing systems (activity source supplied by Customer)
• Dose calibrator verification (activity source supplied by Customer)
• Safety devices and interlocks check
• Operator’s training
• Delivery of the performed FAT protocol and documentation package including:
•• Performed FAT Protocol
•• Maintenance and User’s manual
•• Recommended spare parts list
•• Certificate of compliance
•• As built technical drawings (electrical, mechanical, pneumatic & process schemes)
•• Materials certificates/data sheets
•• Main equipments data sheets
•• Instruments calibration certificates
•• Welding Processes qualification.

6.4 OPTIONAL
6.4.1 IQ & OQ (Installation Qualification & Operational Qualification)
If requested, as an optional service , Comecer can perform IQ-OQ validation at customer’s site. The IQ-OQ validation will be
performed by qualified technicians (Comecer Validation Dept.) using calibrated instruments and the protocol will include
the complete tests list as performed during the FAT, repeated again at customer’s site.

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 TD_FHR1-50-LAF_R10_ENG – 07/11/19

7 AFTER-SALES SERVICE

7.1 MAINTENANCE SERVICES

7.1.1 Preventative Maintenance

Prevent the failure of equipment before it actually occurs and preserve and enhance equipment reliability by replacing worn
components before they actually fail.

7.1.2 On Call Maintenance

Diagnosis: the process of corrective maintenance begins with a failure and a diagnosis of the failure. The diagnostic process
can include a physical inspection of a system, the use of a diagnostic computer to evaluate the system, interviews with
system users. It is important to determine what caused the problem in order to take appropriate action.
Action: on site or by remote access (only for automatic systems). Inspection of the equipment to identify the reason for the
failure and the action to be taken to eliminate or reduce the frequency of future similar failures.
Testing: technician verifies that the fix problem has been fixed by testing the system.

7.2 REMOTE ASSISTANCE / HELP DESK

The service allows connecting to the Comecer computer to access directly all machine functions and verify their proper
operation.
Maintenance Contracts offer
Standard: preventive maintenance + ON CALL (secured lead time).
Full Risk: preventive maintenance + ON CALL (secured lead time) + Spare parts.

7.3 TRAINING & CONSULTING

Additional training for users.
Level 1 maintenance training.
Helping the customer to find the best solution ensuring that both operational and economical needs are optimally met.

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 TD_FHR1-50-LAF_R10_ENG – 07/11/19

8 INSTALLATION REQUIREMENTS
The customer is require to provide a number of pre-arrangements to install the equipment: for details refer to the specific
demo drawing for the configuration in question, provided separately.

8.1 NOTES REGARDING INSTALLATION

The photo below represents an example of the COMECER cells standard installation, as seen from the front side.
The external covering cases are not attached to the ceiling, as it can be seen from the photo. (A).

On customer request, COMECER will close the cells up to the ceiling.

On customer request the cell is made in order to ensure the air tightness between the laboratory and the technical area.

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 TD_FHR1-50-LAF_R10_ENG – 07/11/19

The photo represents an example of the COMECER cells standard installation, as seen from the back side

C
B

A Parts supplied by COMECER: STANDARD FRONT COVERINGS

for the extraction of air, COMECER provides an air
B Parts supplied by COMECER:
extraction fan for every cell;
The connection of the radiofluids lines to the
C Parts not supplied by COMECER
COMECER cell valves is made by the customer;
The hidden parts of the cells (e.g. rear part) are not
D Parts not supplied by COMECER
covered by stainless steel coverings
If the cells are not against the wall, an access door is
E Parts supplied by COMECER on customer request
made in the rear area.

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NOTES:
©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