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