AS 4273-1999

1 - AS 4273-1999 DESIGN, INSTALLATION AND USE OF PHARMACEUTICAL ISOLATORS
4 - PREFACE
5 - CONTENTS
6 - FOREWORD
7 - 1 SCOPE
7 - 2 OBJECTIVE
7 - 3 REFERENCED DOCUMENTS
8 - 4 DEFINITIONS
8 - 4.1 Alarm
8 - 4.2 Background environment
8 - 4.3 Clean environment
8 - 4.4 Controlled work space
8 - 4.5 Docking device
8 - 4.6 Exhaust filter
8 - 4.7 High efficiency particulate air (HEPA) filter
8 - 4.8 Isolator
8 - 4.9 Radiation protection system
8 - 4.10 Sanitization
8 - 4.11 Supply air
8 - 4.12 Transfer device
9 - 4.13 Type 1 Isolator
9 - 4.14 Type 2 Isolator
9 - 4.15 Unidirectional flow
9 - 4.16 Work site
9 - 5 DESIGN PRINCIPLES
9 - 5.1 General
9 - 5.2 Internal surfaces
9 - 5.3 Work space
9 - 5.4 Air change rate
10 - 5.5 Isolator pressure differentials
10 - 5.6 HEPA filter frames
10 - 5.7 HEPA filter testing facility
10 - 5.8 Transfer system
10 - 5.9 Air supply to a fixed transfer device
10 - 5.10 Radiopharmaceuticals
10 - 5.11 Change facility for exhaust filters
10 - 5.12 Discharge and exhaust air treatment
10 - 5.13 Exhaust blower system
10 - 5.14 Leak test
10 - 5.15 Sample ports
11 - 5.16 Pressure differential monitoring
11 - 5.17 Airflow monitoring
11 - 5.18 Alarms
11 - 5.19 Breach of containment
11 - 5.20 Transfer containment
11 - 6 PERFORMANCE
11 - 7 LABELLING
11 - 8 SITING OF ISOLATORS
11 - 8.1 Siting of isolator
11 - 8.2 Background environment
12 - 9 PHYSICAL, OPERATOR AND ENVIRONMENTAL CONTROL AND MONITORING
12 - 9.1 General
12 - 9.2 Commissioning program
13 - 9.3 Filter installation integrity
13 - 9.4 Air velocity
13 - 9.5 Pressure differentials
13 - 9.6 Isolator leak test
13 - 9.7 Glove and sleeve leak test
13 - 9.8 Routine monitoring
13 - 9.9 Cleaning and decontamination
13 - 9.10 Airborne particle counts
13 - 9.11 Time factors
19 - APPENDIX A - PURCHASER-SUPPLIER LIAISON
20 - APPENDIX B - STATUTORY AUTHORITIES FOR RADIATION SAFETY
22 - APPENDIX C - GUIDELINES FOR OPERATOR TRAINING
22 - C1 GENERAL
22 - C2 APPLICATION
22 - C3 HAND WASHING TECHNIQUES AND PROTECTIVE CLOTHING
22 - C4 GLOVES AND GAUNTLETS
22 - C5 TRANSFER SYSTEM
22 - C6 CLEANING
22 - C7 ASEPTIC TECHNIQUE
22 - C8 WORKING WITHIN THE ISOLATOR
22 - C9 VALIDATION
23 - APPENDIX D - GLOVES AND GAUNTLETS
23 - D1 GENERAL
23 - D2 GAUNTLETS
23 - D3 GLOVE/SLEEVE SYSTEM
24 - APPENDIX E - SUMMARY CERTIFICATE OF COMMISSIONING AND ROUTINE RECERTIFICATION TO AS 4273

Provides design requirements and guidance for the construction of pharmaceutical isolators, recommendations for the environment in which they are to be used, performance requirements and guidance on their installation and use.

This Standard gives design requirements and guidance for the construction of pharmaceutical isolators, recommendations for the environment in which they are to be used, performance requirements and guidance relating to their installation and use. It does not refer to flexible film or hybrid isolators or to devices intended to be used for handling of pathogenic organisms.NOTE: Appendix A provides guidance on information that should be discussed between purchaser and supplier.

Draft Amendment 1 see DR 00012 CP First published as AS/NZS 4273(Int):1995.Revised and designated AS 4273-1999. First published as AS/NZS 4273(Int):1995. Revised and designated AS 4273-1999. Originated as AS/NZS 4273(Int):1995. Revised and designated AS 4273-1999. Reissued incorporating Amendment No. 1 (May 2000).