Standard
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AS 4273-1999
[Current]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.
Published: 05/03/1999
Pages: 18
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
PREFACE
FOREWORD
1 SCOPE
2 OBJECTIVE
3 REFERENCED DOCUMENTS
4 DEFINITIONS
5 DESIGN PRINCIPLES
5.1 General
5.2 Internal surfaces
5.3 Work space
5.4 Air change rate
5.5 Isolator pressure differentials
5.6 HEPA filter frames
5.7 HEPA filter testing facility
5.8 Transfer system
5.9 Air supply to a fixed transfer device
5.10 Radiopharmaceuticals
5.11 Change facility for exhaust filters
5.12 Discharge and exhaust air treatment
5.13 Exhaust blower system
5.14 Leak test
5.15 Sample ports
5.16 Pressure differential monitoring
5.17 Airflow monitoring
5.18 Alarms
5.19 Breach of containment
5.20 Transfer containment
6 PERFORMANCE
7 LABELLING
8 SITING OF ISOLATORS
8.1 Siting of isolator
8.2 Background environment
9 PHYSICAL, OPERATOR AND ENVIRONMENTAL CONTROL AND MONITORING
9.1 General
9.2 Commissioning program
9.3 Filter installation integrity
9.4 Air velocity
9.5 Pressure differentials
9.6 Isolator leak test
9.7 Glove and sleeve leak test
9.8 Routine monitoring
9.9 Cleaning and decontamination
9.10 Airborne particle counts
9.11 Time factors
Appendix A
Appendix B
Appendix C
C.1 GENERAL
C.2 APPLICATION
C.3 HAND WASHING TECHNIQUES AND PROTECTIVE CLOTHING
C.4 GLOVES AND GAUNTLETS
C.5 TRANSFER SYSTEM
C.6 CLEANING
C.7 ASEPTIC TECHNIQUE
C.8 WORKING WITHIN THE ISOLATOR
C.9 VALIDATION
Appendix D
D.1 GENERAL
D.2 GAUNTLETS
D.3 GLOVE/SLEEVE SYSTEM
Appendix E
Cited references in this standard
[Current]
High efficiency particulate air (HEPA) filters — Classification, construction and performance
[Superseded]
Cleanrooms, workstations, safety cabinets and pharmaceutical isolators — Methods of test, Method 25: Determination of gas tightness of outer shell of biological safety cabinets and pharmaceutical isolators
[Current]
Air filters for use in general ventilation and airconditioning, Part 2: Methods of test
Content history
[Current]
[Withdrawn]
[Superseded]
DR 98018
AS/NZS 4273(Int)-1995