AS 1386.1-1989
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Cleanrooms and clean workstations - Principles of clean space control
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
30-03-2023
English
01-01-1989
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.
Committee |
ME-060
|
DocumentType |
Standard
|
ISBN |
0 7262 5689 7
|
Pages |
18
|
PublisherName |
Standards Australia
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
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.
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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