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STERIS VHP® DC-A

DECONTAMINATION CHAMBER ATMOSPHERIC


APPLICATION
STERIS VHP® DC-A Decontamination Chamber Atmospheric
is designed for VHP® biodecontamination of materials during
transfer from an area of lower classification to an area of a
higher classification. The Unit is especially suitable for GMP
regulated pharmaceutical companies manufacturing drugs
aseptically.

DESCRIPTION
A typical application of the STERIS VHP® DC-A
Decontamination Chamber Atmospheric is surface
biodecontamination of pre-sterilized material packages, such
as vial stopper bags, wrapped components and syringes.
The DC-A features:
• STERIS's non-condensing vaporized hydrogen peroxide
technology that ensures 6-log reduction of bioburden
(Typical - details may vary.)
• Unique process for reducing particulates on transferred
materials Following on-site installation, STERIS application specialists
also provide on-site acceptance testing and validation support
• Short cycle time with proven biodecontamination result
services ensuring easy and time-saving procedures for
throughout chamber
validation of the process and equipment for the application
• Completely independent system that is easy to install and environment and requirements.
validate
• 21 CRF Part 11 compatibility STANDARDS
• Automated controlled process environment STERIS VHP® DC-A Decontamination Chamber Atmospheric
• No toxic process by-products and products are designed and manufactured to meet CE mark
• Excellent material compatibility and applicable sections of the following European Union
directives:
• Maximized throughput in pre-designed high quality
stainless-steel chamber • Machinery Directive 2006/42/EC
• Low Voltage Directive 2014/35/EU
• Feasibility testing and full load Cycle development tests
with Customer product loads available as an option • Electromagnetic Compatibility (EMC) 2014/30/EU
Common standards used during the design, manufacturing and
• Complete IQ/OQ testing of equipment at factory testing
testing of the biodecontamination chamber is as follows:
area prior to shipment
• EN 60204-1
• Factory Acceptance Test (FAT) in the state of art testing
facility at the factory • IEC 60204-1

The Selections Checked Below Apply To This Equipment


CHAMBER/UNIT SIZES* OPTIONS OPTIONS (Cont’d)
❑ 669 (0.37 m3) ❑ Mirror Construction, Chamber Right Side ❑ Unloading Side Operator HMI Touch Panel
❑ 6612 (0.49 m3) ❑ Trim Panel Set (Each Side) (Enables Full CFR21 Part 11 Compatibility)
❑ 999 (0.80 m3) ❑ Chamber Tracks ❑ FAT Procedures and Results
❑ 9912 (1.06 m3) ❑ Sterilant Room Monitor ❑ Extended Control System Validation
❑ 92115 (2.9 m3) ❑ Two-Piece Construction (Split Crating) Documentation
❑ Air Differential Sterile Seal ❑ Customer Attended FAT (3 Days)
❑ 92118 (3.4 m3)
❑ Load Side ❑xUnload Side ❑ Manufacturing Procedures Documentation
❑ 92121 (4 m3)
❑ Seismic Restraints and Calculations ❑ Ethernet Connection
❑ 92124 (4.5 m3)
❑ Enclosure Side Panels ❑ Particulates Monitoring and Control System
❑ 122115 (3.8 m3) ❑ Right Side ❑xLeft Side ❑ Additional Copy of User’s Manual or Document
❑ 122118 (4.5 m3) ❑ Loading Cart File
❑ 122121 (5.2 m3) ❑ Chamber Surface Finish Inspection Report
❑ 122124 (6 m3) ❑ Spare Parts Kit
❑ Transfer Trolley (Sizes 669-9912) Item ________________________
Location(s)___________________
* Double Door Standard
____________________________

SD1056 (06/01/18)
STERIS quality system has been certified to meet the standard
ISO 9001:2008 Quality Management Systems. Features Benefits
STERIS follows the GAMP 5, A Risk-Based Approach to Factory Acceptance Fully tested at factory according to FAT
Compliant GxP Computerized Systems. Test (FAT) procedures.
STERIS develops, documents and enforces policies and
Standard Safety Redundant door interlock systems, Emergency
procedures ensuring the security of electronic records and
Systems Stop and pneumatic deactivation key switch are
signatures according to 21 CFR Part 11. Together with our
provided to ensure operator safety
Customers, STERIS helps implement and enforce Part 11-
compliant solutions involving validation, audit trails and Secure Access User access levels are password protected for
security of our computer systems. For DC-A Unit, CFR Part secure access to the control
11 option is available. With this option, system includes
Independent of An easily installed and validated system that is
electronic records, electronic signatures, electronic batch
Facility HVAC completely independent from facility HVAC
reports and audit trails. STERIS provides more details as
requested. CFR 21 Part 11 Choosing an optional unloading side Operator
Compatibility HMI, a full CFR 21 part 11 compatibility is
FEATURES achieved

STERIS VHP® DC-A Decontamination Chamber Atmospheric


is designed VHP® biodecontamination of materials prior to
CYCLE DESCRIPTION
transfer from an area of lower classification to an area of a
STERIS VHP® DC-A Decontamination Chamber Atmospheric
higher classification. The system is developed, manufactured
Sterilizer Biodecontamination Cycle consists of three phases:
and tested with the following features:
1. Pre-Conditioning
Features Benefits 2. Biodecontamination
3. Post-Conditioning
STERIS Patented Dry Provides consistent hydrogen peroxide
Vapor Process biodecontaminant for repeatable 6-log reduction PRE-CONDITIONING
of bio-burden. (6-log reduction of a known
Pre-Conditioning phase removes excess moisture and
population of Geobacillius stearothermophilus.)
reduces particles from chamber and load. Pre-conditioning
Low Temperature Allows surface biodecontamination of heat is essential to reduce chamber humidity to enable a
and/or radiation sensitive materials successful hydrogen peroxide biodecontaminant exposure
phase. Too high humidity in chamber leads to low
Non-Toxic Water and oxygen are the only byproducts of
concentration of hydrogen peroxide vapor and suboptimal
Byproducts the process
biodecontamination.
Complete Cycle Surface biodecontamination and aeration can Both chamber and load are flushed with an air flow created
be completed in one process by an internal fan during pre-conditioning. The powerful fan
Particle Reduction Provides a particle reduction method that is located above chamber false ceiling creates a highly
part of standard Biodecontamination Cycle turbulent air flow that effectively loosens particulates off load
and conducts them to HEPA filter. With particulate monitoring
Particle Measurement Optional particle measurement inside chamber and controlling option, amount of particulates inside chamber
to protect integrity of higher classification is measured. At the same time, high air flow though dryer
clean room rapidly removes chamber moisture. Programmable dampers
Chamber Manufactured from AISI 316L stainless steel above false ceiling can be used to further enhance this
process by creating varying air flow patterns inside chamber.
Chamber Sterilant Chamber inlet design provides uniform
Inlet biodecontaminant distribution HYDROGEN PEROXIDE STERILANT EXPOSURE
(BIODECONTAMINATION)
Chamber Validation One dedicated port is provided for sensing and
Ports validation purposes Biodecontamination Phase consists of two distinctive steps:
Room Monitoring Optional hydrogen peroxide biodecontaminant 1. Conditioning Step where vaporized hydrogen peroxide
room monitoring sensor(s) provided to detect sterilant concentration is brought to desired level.
even minimal hydrogen peroxide 2. Hydrogen Peroxide Sterilant Exposure Step where
biodecontaminant presence in the room. desired sterilant vapor concentration is maintained for a
required period of time.
PLC Control Standard, commercially available, PLC control
• CONDITIONING Step
system platform
Hydrogen Peroxide sterilant vapor from a vaporizer is
Operator Interface Color touch screen with Cycle parameters, circulated inside chamber by a fan. Vaporizer flash
alarms and component status vaporizes aqueous hydrogen peroxide solution and
disperses it to airstream in a controlled manner. This step
is used to increase concentration inside enclosure as

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quickly as possible to a level slightly below point of Door Interlock allows only one door to be opened at a time,
saturation. Concentration is gradually increased inside and during processing, prevents either door from being
chamber until correct level has been reached. opened until Cycle is complete.
• EXPOSURE Step Dräger Sensor for biodecontaminate monitoring, sensor
Exposure biodecontamination step begins when optimal interlocked with door ensures door cannot be opened before
Hydrogen Peroxide sterilant concentration inside chamber biodecontaminate concentration inside chamber is below
has been reached. Exposure step holds a concentration predetermined safety level.
inside enclosure just under saturation point until desired CONSTRUCTION
level of bioburden reduction has been achieved. Hydrogen
Peroxide injection rate depends on load configuration, Chamber is manufactured from AISI316L stainless steel. As
temperature, materials and chamber size. Exact exposure standard chamber doors are manufactured from PE-HD. All
time depends also on load qualities such as material and chambers are designed and manufactured in accordance to
packing density and needs to be validated for each load application requirements.
type separately.
Double door is standard chamber configuration, as it provides
POST-CONDITIONING a pass-through from NS loading side and opens to ST
unloading side after Cycle.
During this phase, load is aerated by circulating air and
hydrogen peroxide sterilant vapor through HEPA filter to Note chamber net size is 300 mm smaller in height compared
remove vapor from load and chamber prior to cycle end. to nominal chamber size for ceiling fan assembly. For
Vapor is converted into water and oxygen by using a built-in example, 92115-chamber size has 91815 net size and volume.
catalytic converter system. The amount of residual hydrogen STERIS VHP® DC-A Decontamination Chamber Atmospheric
peroxide sterilant is measured by gas sensors. Safe opening has following mechanical features:
of chamber door is ensured by both time limitation (before • Chamber is rectangular design with applicable radius in
opening door is possible) and concentration measurement. corners.
NOTE: Post-conditioning time depends on load configuration, • Doors are sealed to chamber by active non-lubricated door
materials (adhesives, plastic type, etc.) and load temperature
gaskets driven by air pressure.
/ humidity conditions.
• Electric safety key lock feature for doors provides a safety
SAFETY FEATURES lock system for disabling all chamber functions during
service and cleaning operations.
Emergency Stop Button, located on both sterile (ST) and
non-sterile (NS) sides of the Unit, returns valves to safe • As standard, inner chamber walls and doors are
condition and halts Cycle processing when pressed. Once mechanically polished to minimum Ra 0.6 µm or better.
pressed, operator chooses to either abort or continue Cycle • All chamber welds are ground smooth.
operation. • All gaskets used for connections are of pharmaceutical
User Lever Password Administration prevents access of grade PTFE (Teflon), silicone or EPDM.
unauthorized users to critical operational modes. Three
MOUNTING ARRANGEMENT
access levels are available:
1. Operator Level: Allows operator to select and start Cycle, Biodecontamination chamber is designed for freestanding or
view Cycle parameters and order control to print limited recessed mounting through one or two walls. All unit
reports. components are integrally mounted within footprint (refer to
2. Service Level: Allows operator to select and start Cycle, Equipment drawing). Each biodecontamination chamber is
view Cycle parameters, print reports, calibrate instruments equipped with adjustable leveling legs.
and activate/deactivate inputs and outputs, edit common
settings, change date/time and view service diagnostics. OPTIONS
3. Administrator Level: Allows operator to select and start
Cycle, view Cycle parameters, print reports, calibrate Mirror Construction reverses standard positioning of
instruments and activate/deactivate inputs and outputs, sterilizer chamber and maintenance area. Standard
edit common settings, change date/time, view service configuration is chamber on left and maintenance space is
diagnostics and edit passwords. on right side when looking at unit from loading/main side of
Acknowledge Button with a Key Lock for doors provides a use. In Mirror construction, this arrangement is reversed and
safety lock system for disabling all chamber functions during a Chamber is on Right Side and maintenance space on left.
service and cleaning operations. This feature has two safety Trim Panel Set (Each Side) are provided for sealing gap
functions: acknowledge button needs to be pressed each between Unit fascia panels and facility wall opening for
time before Cycle is initiated (acknowledge button placement recessed one or two wall installations. Panels are
forces user to ensure visually that it is safe to start Cycle; manufactured of AISI 304 stainless steel. Select this option
during maintenance or cleaning, key can be removed by a when other sealing methods such as dry wall installation or
person doing maintenance ensuring unit cannot be started on-site sheet metal fabrication are not available. Customer’s
inadvertently. room layout drawing is required for designing the trim panels.

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Enclosure Side Panel (Right Side) is installed on the right throughput. Product details need to be provided to optimize
of Unit framework as specified to conceal internal piping, and design of load pattern, size and weight. Some typical features
unit mechanical and electrical components. This stainless- include:
steel panel may be needed if unit is installed as recessed one • Stainless-steel frame design
wall installation with a need to cover equipment (for example:
• Cart size (chamber net size) is 300 mm lower in height to
installation into left -hand corner of room).
nominal size (e.g., 92115 cart and chamber size is 91815)
Enclosure Side Panel (Left Side) is installed on the left of • Equipped with four fixed wheels
Unit framework as specified to conceal internal piping, and
• Multiple carts can be provided depending on chamber
unit mechanical and electrical components. This stainless-
size to help facilitate loading and minimize weight. Note
steel panel may be needed if unit is installed as recessed one
standard arrangement is one cart for sizes 669-92115, two
wall installation with a need to cover equipment (for example:
carts for 122118 and four carts for larger size chambers.
installation into right -hand and corner of room).
Any different cart arrangement from this standard must be
Seismic Restraints and Calculations provide Unit with quoted separately a SSQ.
seismic anchorage designed to meet seismic zone four
• Cart(s) are supplied with shelves depending on product
requirements. Angle brackets and frame mounting hardware
load configuration. Materials are typically stainless steel or
are manufactured from AISI 304 stainless steel and are
polymer based and are compatible with
provided by STERIS. The Hilti type, or equivalent, floor anchors
biodecontaminant. Shelves are customized for each
are provided and embedded (not by STERIS) into the concrete
project and product via the SSQ system.
floor. Calculations are per latest California UBC as standard
and certified by a California registered Engineering Company. • Transfer trolley is available as standard option for unit sizes
Other calculations are available upon request and may require 669-9912. Other sizes available upon request (e.g., when
additional cost. Seismic calculations are located in the independent trolley loading and unloading is required to
Manufacturing Documentation. have carts without wheels).

Two-Part Construction (Split Crating) design allows unit to Tracks in chamber are installed to guide the cart(s) during
be delivered in two pieces. Chamber part and maintenance loading and unloading procedures. Tracks are AISI #316L
space skid are separated for easier hauling in tight building stainless steel. A transfer trolley is required with this option if
corridors etc. the unit is not pit mounted (91515 size chamber only).

Air-Differential Seal (Sterile Side) is provided at sterile end Biodecontaminant Room Monitor is used to detect even
of Unit to maintain pressure difference between Unit service very low concentrations of hydrogen peroxide
area and classified area. Seal is fabricated from AISI 304 biodecontaminant in area. Monitor alarms if
stainless steel. Silicone caulking is used to seal panels within biodecontaminant levels exceed acceptable limits (> 1 ppm).
Unit frame. Adjustable interface panels are provided at top, Customer Attended FAT option enables execution of FAT
bottom and both sides with a silicone gasket to seal system document with Customer attendance. Document is provided
to facility structure. Air differential seal on both sides is a in as-built documentation package. Includes Customer
Special Sales Quotation (SSQ) offer. attended FAT time. Travel expenses not included.
Air Differential Seal (Non-Sterile Side) is provided at non- Unloading Side Operator HMI (Human Machine Interface)
sterile end of Unit to maintain pressure difference between Touch Panel for control is provided on sterile side instead of
Unit service area and classified area. Seal is fabricated from just standard indicator light. HMI touch panel (sterile side) is
AISI 304 stainless steel. Silicone caulking is used to seal used for selecting and starting Cycles and displaying real-
panels within Unit frame. Adjustable interface panels are time process data and alarms. This option needs to be
provided at top, bottom and both sides with a silicone gasket selected if full CFR 21 Part 11 compatibility is required.
to seal system to facility structure. Air differential seal on both Ethernet With SCADA List and NAT Device option provides
sides is a SSQ offer. a SCADA list. For easy setup and maintenance of IP
Chamber Tracks are mounted in chamber floor to guide addresses, a Siemens Scalance Series NAT device is
loading cart system. included.
Spare Parts Kit containing selected mechanical and Particulates Monitoring and Control System option adds
electrical components is provided to fulfill two-years normal two sensors for particulate monitoring and controlling
maintenance and operation of unit. Components typically purposes. Reduction of particulates inside chamber is
provided are valve rebuild kits, solenoid valve, temperature measured with a Sintrol S303 Dust Monitor sensor located in
sensor, pressure sensor, door gaskets and other applicable duct before HEPA filter. Load and chamber are flushed with
components. Additional parts may be required for other HEPA filtered air until pre-programmed cleanliness level is
features. reached. Particulates control system enables user to set
Loading Cart System is custom designed and used to chamber impurity level to match exactly target clean room
support and convey assorted products in loading, area conditions.
biodecontaminating and unloading process. Loading HEPA filter integrity is continuously monitored by an on-line
equipment is a critical component for unit process and measurement with Sintrol A1+ Snifter sensor. Sensor causes
an alarm in case of HEPA filter malfunction.

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Extended Control System Validation Documentation Manufacturing Procedures Documentation includes:
Package adds the following material to the standard package: • Manufacturing Procedures Documentation binder
• Software Design Specification provides the following internal procedures:
• Hardware Specification » Mechanical Grinding and Polishing Procedure (SOP
• Software Test Documentation T-6012)
» Pickling and Passivation Procedure (SOP T-6013)
• PLC Change Control Documentation
» Surface Roughness Measuring of Vessels Procedure
NOTE: Validation and Customer defined requirements remain
(SOP L-8001)
the sole responsibility of the Customer.
• Chamber Surface Finish Inspection Report option. As
FAT Procedures and Results were developed for the
standard, the procedure for inspection of the Chamber
purpose of providing written qualification procedures that can
surface finish is by random inspection during
be implemented into a Customer's validation plan for FAT
manufacturing by the Quality Assurance (QA) department.
Testing. Procedures and Results Package integrates detailed
With this option, the instrument documentation and data
written procedures and test plans into the FAT report. This
of the surface finish measurements are provided with the
material may then be used as a basis for the Customer's
Manufacturing Documentation.
Standard Operating Procedures (SOPs) used to complement
the Customer IQ/OQ requirements during Site Acceptance • Vessel documentation includes:
Test (SAT). » Surface Finish Measurement Points
With this option, blank forms are provided on a USB Memory » Measuring Data
Stick (MS Word format). » Ra-Reference Piece Calibration Certificate
FAT Procedures and Results package adds following NOTE: Surface finishes are documented as Ra-values in
standard package: micrometers (µm).
• Specification reference source NOTES
• Testing Pre-requisites
• Installation Checks procedures1 1. The VHP® biodecontamination options are to be used by
trained and certified Applicators who have successfully
• Operational Checks procedures1 completed both the STERIS Training and Certification
Each test procedure or report is segmented with the following Course for applicators of Vaprox Hydrogen Peroxide
information fields: Sterilant and the VHP pertinent Sterilization System
Operator Course. Certification must be active and in force
• Document title for all Applicators of Vaprox Hydrogen Peroxide Sterilant.
• Alphanumeric test reference identification
2. Consult Vaprox Hydrogen Peroxide Sterilant SDS, label
• Test objective and package insert for information regarding storage and
• Additional test comments block handling of Cartridges.

• Results block (pass/fail) 3. Refer to equipment drawings showing all utility and space
requirements for actual installation specifications.
1 Unambiguous step-by-step procedures or protocols (step/action) for each Clearances shown are minimum required for servicing
test performed with individual acceptance criteria and comprehensive
description of anomalies with corrective actions to resolve any deviations.
equipment. Floor surface must be hard and level.

Additional Copy of User's Manual or Document File option.


An additional hard copy of the complete documentation set CUSTOMER IS RESPONSIBLE FOR COMPLIANCE WITH
is provided, including the user's manual, FAT documentation, APPLICABLE LOCAL AND NATIONAL CODES AND
REGULATIONS.
as well as the manufacturing and control system
documentation (standard and optional). Manufacturer's
booklets and CDs for installation, operation and maintenance
for control systems, instrumentation and components are
excluded. The base language of this document is
Load Cycle Development Services and testing is ENGLISH. Any translations must be made
from the base language document.
encouraged to be part of the FAT for new applications. This
development test is to ensure a Cycle can be run with a full
load in chamber and is a starting point for Cycle optimization
or Performance Qualification (PQ) activities. This testing is
expected to be conducted over a 7-14 day period and is
performed after FAT document is executed. Refer to quotation
for specific number of days included for this testing. Customer
is expected to provide support during test period. Travel
expenses are not included with this option.
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UTILITY REQUIREMENTS/ENGINEERING DATA
Refer to equipment drawing for installation details and specifications.

Utility Pressure Remarks


Vaprox® Hydrogen Peroxide Sterilant N/A Cartridge Fill (950 mL)

Instrument Air 5-8 bar


(73 - 116 psig)

Electricity Variance Not to Exceed + 10% of Nominal 3 PH / 50 Hz / 400 Vac


(Main Unit) Supply Voltage. 3 Phase (PH) + PE + N Are 3 PH / 60 Hz / 480 Vac
Required for Unit Cabling. 3 PH / 60 Hz / 220 Vac
3 PH / 60 Hz / 600 Vac

Chamber (Load) Size Unit Outer Dimensions


Usable Volume
Unit (W x H x D) (W x H x D)
(m3)
(mm) (mm)
669 650 x 620 x 921.5 1327 x 2144 x 1040 0.37

6612 650 x 620 x 1221.5 1327 x 2144 x 1340 0.49

999 950 x 920 x 921.5 1627 x 2144 x 1040 0.80

9912 950 x 920 x 1221.5 1627 x 2144 x 1340 1.06

92115 950 x 1919 x 1578 1974 x 2781 x 2032 2.88

92118 950 x 1919 x 1878 1974 x 2781 x 2332 3.42

92121 950 x 1919 x 2178 1974 x 2781 x 2632 3.97

92124 950 x 1919 x 2478 1974 x 2781 x 2932 4.52

122115 1250 x 1919 x 1578 2274 x 2781 x 2032 3.79

122118 1250 x 1919 x 1878 2274 x 2781 x 2332 4.50

122121 1250 x 1919 x 2178 2274 x 2781 x 2632 5.22

122124 1250 x 1919 x 2478 2274 x 2781 x 2932 5.94

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For Further Information, contact:

STERIS Corporation
5960 Heisley Road
Mentor, OH 44060-1834 • USA
440-354-2600 • 800-548-4873
www.STERISLifeSciences.com

This document is intended for the exclusive use of STERIS Customers, including
architects or designers. Reproduction in whole or in part by any party other than
SD1056 ©2018, STERIS Corporation. All rights reserved. (06/01/18) a Customer is prohibited.