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AS 1386.1-1989

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Cleanrooms and clean workstations - Principles of clean space control
Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

03-30-2023

Language(s)

English

Published date

01-01-1989

Preview

1 - AS 1386.1-1989 CLEANROOMS AND CLEAN WORKSTATIONS - PRINCIPLES OF CLEAN SPACE CONTROL
4 - PREFACE
5 - CONTENTS
6 - FOREWORD
7 - 1 SCOPE.
7 - 2 REFERENCED DOCUMENTS.
7 - 3 DEFINITIONS.
7 - 3.1 Anteroom
7 - 3.2 Cleanroom
7 - 3.3 Clean space
7 - 3.4 Clean workstation
8 - 3.5 Critical work object
8 - 3.6 Design conditions
8 - 3.7 Final filter
8 - 3.8 First air
8 - 3.9 FRED room
8 - 3.10 HEPA filter
8 - 3.11 Laminar airflow
8 - 3.12 Laminar flow cleanroom
8 - 3.13 Main filter
8 - 3.14 Non-laminar flow cleanroom
8 - 3.15 Operational conditions
8 - 3.16 Outdoor air
8 - 3.17 Prefilter
8 - 3.18 Primary air
8 - 3.19 Safety cabinet
8 - 3.20 Secondary air
8 - 3.21 Secondary filter
8 - 3.22 ULPA filter
11 - 3.23 Work zone
11 - 4 CLASSES OF AIR CLEANNESS.
13 - 5 DESIGN CRITERIA AND GENERAL PRINCIPLES OF CLEAN SPACE CONTROL.
13 - 5.1 Airborne particles.
13 - 5.2 Particulate control.
14 - 5.3 Air pattern control.
20 - 5.4 Pressurization / outdoor air.
20 - 5.5 Temperature control.
20 - 5.6 Humidity control.
20 - 5.7 Lighting.
20 - 5.8 Sound level.
20 - 5.9 Room construction.
20 - 5.10 Management of filters.
21 - 5.11 Testing.
22 - 5.12 Anterooms.
22 - 5.13 Cleanroom garments.
23 - APPENDIX A - GUIDELINES FOR ACHIEVING AIR CLEANNESS CLASSES

Introduces a classification of air cleanness and explains the principles of clean space control. Six classes of air cleanness are specified for the work zone of clean spaces under operational conditions. The Standard complements the specific requirements set out in other parts of the series.

This Standard sets out the principles of clean space control. Six classes of air cleanness are specified and guidelines are given for the selection of airflow patterns, control of temperature and humidity, regulation of air pressure, materials and construction techniques, as well as operating procedures. The clean spaces may be achieved in rooms, or in workstations or safety cabinets within a room.NOTES:1. The designs of cleanrooms illustrated in this Standard are typical of existing installations which consistently demonstrate satisfactory performance. However, the principle criterion for room design is the achievement of the desired class of air cleanness. Alternative designs, such as those of large dimensions or, those constructed to protect specialized equipment and processes but which attain the same level of air cleanness as specified in the Standard, are acceptable within the limits of AS 1386.2, AS 1386.3 or AS 1386.4, as applicable. The ultimate test of the performance of clean space systems is that components processed within the facilities they serve economically comply with the manufacturing standards imposed upon them.2. Specific requirements for laminar flow cleanrooms, non-laminar flow cleanrooms, and clean workstations are specified in AS 1386.2, AS 1386.3, AS 1386.4 and AS 1386.5. Similarly, AS 1386.6 and AS 1386.7 specify requirements for operation and inspection of cleanrooms and installation and use of workstations. Requirements for safety cabinets are specified in AS 2252.1, AS 2252.2, AS 2567, AS 2639 and AS 2647. Separate specifications and related documents cater for certain vital components, e.g. air filters.

Committee
ME-060
DocumentType
Standard
ISBN
0 7262 5689 7
Pages
18
PublisherName
Standards Australia
Status
Superseded
SupersededBy
Supersedes

Uncer Revision see DR 01303 CP

AS 1386.5-1989 Cleanrooms and clean workstations - Clean workstations
AS 2639-1994 Laminar flow cytotoxic drug safety cabinets - Installation and use
AS 1386.3-1989 Cleanrooms and clean workstations - Non-laminar flow cleanrooms - Class 350 and cleaner
AS 1324-1973 Air filters for use in air conditioning and general ventilation
AS 1386.2-1989 Cleanrooms and clean workstations - Laminar flow cleanrooms
AS 1386.4-1989 Cleanrooms and clean workstations - Non-laminar flow cleanrooms - Class 3500
AS 1386.7-1989 Cleanrooms and clean workstations - Installation and use of clean workstations
AS 1132.5-1973 Methods of test for air filters for use in air conditioning and general ventilation Arrestance efficiency, average arrestance efficiency, dust-holding capacity, and dust-holding capacity per unit of effective face area for test dusts Nos 1, 2 and 3
AS 2567-2002 Laminar flow cytotoxic drug safety cabinets
AS 2013.1-1989 Cleanroom garments - Product requirements
AS 2013.2-1989 Cleanroom garments - Processing and use
AS/NZS 2647:2000 Biological safety cabinets - Installation and use
AS 1386.6-1989 Cleanrooms and clean workstations - Operation and inspection of cleanrooms
AS 2252.1-2002 Biological safety cabinets - Biological safety cabinets (Class I) for personnel and environment protection
AS 2252.2-2004 Biological safety cabinets - Laminar flow biological safety cabinets (Class II) for personnel, environment and product protection

AS 1807.4-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Determination of performance of laminar flow cleanrooms under loaded filter conditions
AS 1807.11-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Determination of airflow parallelism in laminar flow cleanrooms
AS 1807.6-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Determination of integrity of terminally mounted HEPA filter installations
AS/NZS 4273(INT):1995 Guidelines for the design, installation and use of pharmaceutical isolators
AS 1807.15-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Determination of illuminance
AS 1094-1993 Medical equipment - Single-use syringes (sterile) for general medical use
AS 4273-1999 Design, installation and use of pharmaceutical isolators
AS 2639-1994 Laminar flow cytotoxic drug safety cabinets - Installation and use
AS 1807.24-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Determination of recovery times of cleanrooms
AS/NZS 2869:1998 Tampons - Menstrual
AS 3787.1-1997 General requirements for single-use, sterile, plasticized polyvinyl chloride (PVC) packs for human blood - Single blood packs
AS 1807.23-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Determination of intensity of radiation from germicidal ultraviolet lamps
AS 1807.7-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Determination of integrity of HEPA filter installations not terminally mounted
AS 1077-1992 Single-use syringes (sterile) for the injection of 100 units per millilitre insulin (U-100)
AS 1807.1-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Determination of air velocity and uniformity of air velocity in clean workstations, laminar flow safety cabinets and pharmaceutical isolators
AS 1807.16-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Determination of sound level in cleanrooms
AS 2013.2-1989 Cleanroom garments - Processing and use
AS 3787.2-1997 General requirements for single-use, sterile, plasticized polyvinyl chloride (PVC) packs for human blood - Multiple blood pack systems
AS 4187-1994 Code of practice for cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities
AS 1807.10-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Determination of air pressure of cleanrooms and pharmaceutical isolators
AS 1807.2-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Determination of performance of clean workstations, laminar flow safety cabinets and pharmaceutical isolators under loaded filter conditions
AS 1807.17-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Determination of vibration in cleanrooms
AS/NZS 2869:1995 Tampons - Menstrual
AS 1386.4-1989 Cleanrooms and clean workstations - Non-laminar flow cleanrooms - Class 3500
AS 1807.13-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Determination of relative humidity in cleanrooms
AS 1807.0-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test List of methods and apparatus
AS 1386.5-1989 Cleanrooms and clean workstations - Clean workstations
AS 1807.21-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Determination of inward air velocity of Class I biological safety cabinets
AS 1807.9-1989 Cleanrooms, workstations and safety cabinets - Methods of test Particle counting in cleanrooms by microscopic sizing and counting
AS 1807.20-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Determination of sound level at installed workstations, safety cabinets and pharmaceutical isolators
AS 1807.12-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Determination of temperature in work zones
AS 1807.3-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Determination of air velocity in laminar flow cleanrooms
AS 1807.5-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Determination of work zone integrity
AS 1807.19-1989 Cleanrooms, workstations and safety cabinets - Methods of test Sizing and counting of particulate contaminants in and on cleanroom garments
AS 2869-2008 Tampons - Menstrual
AS 1807.18-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Determination of vibration in workstations, safety cabinets and pharmaceutical isolators
AS 1386.7-1989 Cleanrooms and clean workstations - Installation and use of clean workstations
AS 3787.2-1992 General requirements for single-use, sterile, plasticized polyvinyl chloride (PVC) blood packs for whole blood and blood components - Multiple blood pack systems
AS 1807.22-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Determination of air barrier containment of laminar flow safety cabinets
AS 1807.8-2000 Cleanrooms, workstations, safety cabinets and pharmaceutical isolators - Methods of test Particle counting in work zone by automatic particle counter
AS 1386.3-1989 Cleanrooms and clean workstations - Non-laminar flow cleanrooms - Class 350 and cleaner
AS 1386.2-1989 Cleanrooms and clean workstations - Laminar flow cleanrooms

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