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TitleTR4810_TOC
TagsTechnology Wellness Verification And Validation Sterilization (Microbiology)
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Page 1

2010

Technical Report No. 48
Moist Heat Sterilizer Systems:
Design, Commissioning,
Operation, Qualification and
Maintenance

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Page 2

Moist Heat Sterilizer Systems:
Design, Commissioning, Operation, Qualification and Maintenance Task Force

Kimberly Brown, PhD, Amethyst Technologies, LLC

Linda M. Graf, Pfizer, Inc.

Michael J. Guyader, Lonza

Matthew E. Hofacre, Steris Corporation

Richard E. Kettlewell, GlaxoSmithKline

Colin Meldrum, Ciba Vision Sterile Manufacturing

Ronald J. Nekula Sr., Bayer Healthcare

Anton Ponomarenko, Bayer Healthcare

Cody Riley, Amgen, Inc.

Christopher J. Smalley, PhD, Pfizer, Inc.

Victor Tsui, P.E., cGMP Associates, Inc.

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Page 3

Moist Heat Sterilizer
Systems:
Design, Commissioning,
Operation, Qualification
and Maintenance

Technical Report No. 48

ISBN: 978-0-939459-29-2

© 2010 Parenteral Drug Association, Inc.

All rights reserved.

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Page 4

Table of Contents

1.0 INTRODuCTION ...................................................4
1.1 Purpose / Scope ............................................... 4

2.0 GlOSSaRy OF TeRMS .........................................7

3.0 STeRIlIzaTION PROCeSSeS ..............................12
3.1 Saturated Steam Processes ............................ 12

3.1.1 Gravity Displacement Process ................. 13
3.1.2 Pre-Vacuum Process ................................ 13

3.2 Air Overpressure Processes ........................... 14
3.2.1 Steam Air Mixture Process and

Superheated Water Process .................... 14
3.3 Decontamination Processes ........................... 15
3.4 GMP and Non-GMP Sterilizers ........................ 16

4.0 COMPReHeNSIve STeRIlIzeR
SySTeM DeSIGN ................................................18
4.1 User Requirements Specifications .................. 19

4.1.1 Equipment Location, Installation, and
Maintenance Access Considerations....... 19

4.1.2 Assessing Process Requirements ............ 22
4.2 System Control ............................................... 23
4.3 Functional Requirements Specifications ......... 24
4.4 Detailed Design Specification ......................... 25

5.0 eQuIPMeNT veRIFICaTION
& QualIFICaTION ..............................................26
5.1 Commissioning ............................................... 26

5.1.1 Factory Acceptance Testing .................... 27
5.1.1.1 Leveraging the FAT ............................. 28
5.1.1.2 Software Tests ................................... 29

5.1.2 Site Acceptance Testing ........................... 29

5.2 Qualification ................................................... 30
5.2.1 Static Equipment Qualification or IQ ........ 30

5.2.1.1 Steam Quality Testing ......................... 30
5.2.1.1.1 Prerequisites to Physical,

Chemical and Endotoxin
Testing of Pure Steam .................. 30

5.2.1.1.2 Physical, Chemical and
Endotoxin Testing ........................ 31

5.2.2 Dynamic Equipment Qualification or OQ .. 31
5.2.2.1 Empty Chamber

Temperature Distribution .................... 31

6.0 CyCle DevelOPMeNT .......................................32

6.1 Preliminary System Testing ............................. 32
6.2 Thermal Measurement Test Equipment .......... 32
6.3 Sterilization Cycle Optimization ....................... 33

6.3.2 Pressure Vacuum (Pre-vacuum)
Cycle Development .................................. 42

7.0 ON-GOING CONTROl .........................................43

7.1 Sterilizer System Maintenance ....................... 43
7.2 Calibration ...................................................... 44

7.2.1 Calibration Records .................................. 45

8.0 DOCuMeNTaTION .............................................46

9.0 aPPeNDIx ..........................................................47

Appendix A: Design Considerations ..................... 47
Appendix B: Sterilizer Verification Activities ......... 58
Appendix C: Documentation ................................. 62

10.0 ReFeReNCeS .....................................................63

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Figure 1.1-1 validation life-Cycle
activities ................................. 6

Table 3.3-1 BioSafety levels and
Sterilizer Requirements ........ 15

Figure 3.3-1 Decontamination and
Standard Steam Flow
Cycle Comparison ................. 16

Table 3.4-1 GMP and Non-GMP
Comparison Chart ................. 17

Table 4.0-1 Design Qualification
example ................................ 18

Figure 4.1.1-1 Facility Design
example One ......................... 20

Figure 4.1.1-2 example of Dual
Wall Seals ............................. 21

Figure 4.1.1-3 example of Wall
Seal Facility Design .............. 21

Figure 5.1.1-1 Sterilizer Manufacture
and Testing ............................ 28

Figure 6.3-1 example of Heating uniformity
Problem During Initial
Development Study ............... 34

Figure 6.3-2 example of Heating uniformity
Progression During Cycle
Development Study ............... 34

Figure 6.3-3 example of Heating uniformity
Progression During Cycle
Development Study ............... 35

Table 6.3-1 Cycle Optimization
Considerations Table............. 36

Figure a-1 example of Sterilizer
Chamber ................................ 47

Figure a-2 example of Sliding Door ....... 49
Figure a-3 example of Swing Door ........ 49
Figure a-4 example of active

Door Gasket .......................... 50
Figure a-5 example of Inlet air Filter ..... 52
Figure a-6 example of Typical liquid

Ring vacuum Pump ............... 52
Figure a-7 example of Sterilizer Control

Panel with HMI ..................... 53
Figure a-8 example of electric

Steam Generator ................... 55
Figure a-9 example of air

Differential Seal .................... 57
Figure a-10 example of Biological

Safety Seal ............................ 57
Figure C-1 Documentation ...................... 62

FIGuReS aND TaBleS INDex

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Page 6

4 © 2010 Parenteral Drug Association, Inc. Technical Report No. 48

1.0 Introduction

Moist Heat Sterilization is a process that uses moist heat as the lethal agent to render liquid and po-
rous/hard goods items free of viable microorganisms. There are two main types of processes used
in moist heat sterilization: saturated steam sterilization and air overpressure sterilization. Saturated
steam sterilization is used primarily for porous, hard goods loads, while air overpressure is used for
liquid loads.

Sterilizers are used to sterilize many types of articles, including:

Porous/hard goods, e.g., equipment, tools, laboratory glassware, product components, packaging, •
or devices

Product components that are not part of a porous or liquid load, e.g., vials and syringes•

Cleaning materials and product intermediates•

Product in final containers (terminal sterilization)•

Heat labile media•

Biological solutions and products, equipment, tools •
Air over-pressure applications are used to minimize destruction or distortion of plastic containers or
syringes containing liquids.

The primary objective of the task force was to develop a science-based technical report on moist
heat sterilizers that may be used in all regulatory environments and can be used by organizations to
develop their own program for equipment qualification. To this end, prescription has been avoided,
and region-specific regulatory expectations are not always addressed. This report should be considered
a guide and is not intended to establish standards for sterilization systems. It is intended to be a single-
source overview that complements existing documents listed in the reference section. References
to appropriate and up-to-date scientific publications, international regulatory documents, journal
articles, technical papers and books are used where more detail and supportive data can be found.

The task force was composed of European and North American industry professionals to ensure the
methods, terminology and practices of sterilization science presented reflect sound science and can
be used globally. This technical report was disseminated in draft for public review and comment.

1.1 Purpose / Scope
This Technical Report addresses moist heat sterilizers intended for use in the pharmaceutical, medical
device and biotechnology industries. This technical report focuses on the design and operation of
moist heat sterilizers, from the development of User Requirements Specifications (URS) through
equipment qualification (Installation Qualification (IQ)/Operational Qualification (OQ)) and
culminating with ongoing maintenance requirements. The focus of this report does not include
Performance Qualification (PQ). The reader is directed to PDA Technical Report No. 1: Validation of Moist
Heat Sterilization Processes Cycle Design, Development, Qualification and Ongoing Control for discussion of
load cycle development and process Performance Qualification. (1)

This technical report addresses:

Setting User Requirements and Specifications•

Design Qualification (DQ)•

Equipment and Control System Design•

Functional Requirements for the moist heat sterilizer and expectations for utilities supporting the •
sterilizer

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