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AS 1807:2021
[Current]Separative devices — Biological and cytotoxic drug safety cabinets, clean workstations and pharmaceutical isolators — Methods of test
Specifies requirements and test methods for the testing of separative devices, comprising biological and cytotoxic drug safety cabinets, clean workstations and pharmaceutical isolators. Applies to manufactured products that meet the requirements of AS 2252 Parts 1 to 6 and AS 4273. KEYWORDS: Separative device, drug safety cabinet, clean workstation
Published: 01/04/2021
Pages: 47
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
Introduction
1 Scope and general
1.1 Scope
1.2 Application
1.3 Normative references
1.4 Terms and definitions
2 General provisions
2.1 Time estimates
2.2 Precautions against contamination for users
2.3 Ongoing testing
3 Apparatus
3.1 Defining the equipment
3.2 Calibration and documentation
3.3 Anemometer
3.3.1 General
3.3.2 Vane anemometer
3.3.3 Thermal anemometer
3.4 Manometers
3.5 Restrictive air flow devices
3.6 Ammeters
3.7 Aerosol photometers
3.8 Aerosol photometer probe tips
3.8.1 General
3.8.2 Photometer probe tip for filter integrity testing
3.9 Aerosol generator and fittings
3.10 Aerosol test liquid
3.11 Aerosol delivery hose
3.12 Aerosol barrier test discharge fitting
3.13 Connection fittings
3.14 Light meters
3.14.1 Illuminance meter
3.15 Ultraviolet meter
3.16 Sound level meter
3.16.1 General
3.16.2 Acoustic calibrators
3.17 Vibration meters
3.18 Apparatus for particle counts
4 Methods of test
4.1 Test method 1: Determination of air velocity and uniformity of air velocity
4.1.1 Scope
4.1.2 Principle
4.1.3 Apparatus
4.1.4 Procedure
4.1.5 Report
4.2 Test method 2: Determination of fan blower performance under loaded filter conditions, alarm adjustment and energy use
4.2.1 Scope
4.2.2 Principle
4.2.3 Test criteria
4.2.4 Apparatus
4.2.5 Procedure
4.2.6 Report
4.3 Test method 3: Determination of work zone integrity
4.3.1 Scope
4.3.2 Principle
4.3.3 Test criteria
4.3.4 Aerosol test liquid
4.3.5 Apparatus
4.3.6 Procedure
4.3.7 Report
4.4 Test method 4 — Determination of integrity of HEPA filter installation
4.4.1 Scope
4.4.2 Principle
4.4.3 Aerosol test liquid
4.4.4 Apparatus
4.4.5 Installed filter system leakage tests
4.4.5.1 General
4.4.5.2 Procedure — Terminally mounted HEPA filters
4.4.6 Replacement of HEPA filters
4.4.7 Report
4.5 Test method 5: Determination of illuminance
4.5.1 Scope
4.5.2 Principle
4.5.3 Apparatus
4.5.4 Procedure
4.5.5 Report
4.6 Test method 6: Determination of vibration
4.6.1 Scope
4.6.2 Principle
4.6.3 Apparatus
4.6.4 Procedure
4.6.5 Determination of root mean square (r.m.s.)velocity
4.6.6 Report
4.7 Test method 7: Determination of sound levels
4.7.1 Scope
4.7.2 Principle
4.7.3 Apparatus
4.7.4 Procedure
4.7.5 Report
4.8 Test method 8: Determination of inward air velocity of Class I biological safety cabinets
4.8.1 Scope
4.8.2 Principle
4.8.3 Apparatus
4.8.4 Procedure
4.8.5 Report
4.9 Test method 9: Determination of air barrier containment of Class II biological and cytotoxic drug safety cabinets
4.9.1 Scope
4.9.2 Principle
4.9.3 Aerosol test liquid
4.9.4 Apparatus
4.9.5 Procedure
4.9.6 Report
4.10 Test method 10: Determination of intensity of radiation from germicidal ultraviolet lamps
4.10.1 Scope
4.10.2 Principle
4.10.3 Apparatus
4.10.4 Procedure
4.10.5 Report
4.11 Test method 11: Determination of leak detection of outer shell of biological safety cabinets and pharmaceutical isolators
4.11.1 Scope
4.11.2 Principle
4.11.3 Apparatus
4.11.4 Reagents
4.11.5 Procedure
4.11.6 Report
4.12 Test method 12: Determination of air barrier containment in biological safety cabinets and cytotoxic drug safety cabinets — Potassium iodide “KI” discus test
4.12.1 Scope
4.12.2 Principle
4.12.3 Test requirements
4.12.4 Reagents
4.12.5 Apparatus
4.12.6 Preparation for tests
4.12.7 Procedure
4.12.8 Check procedure
4.12.9 Calculations
4.12.10 Test report
4.13 Airflow visualization for CDSC exhaust
4.13.1 General
4.13.2 Test criteria
4.13.3 Apparatus
4.13.4 Procedure
4.13.5 Report
Appendix A
Appendix B
B.1 Acquired infections
B.2 Brucella spp
B.3 Typhoid: salmonella typhi and salmonella para typhi
B.4 Neisseria meningitidis
Appendix C
Appendix D
Bibliography
Cited references in this standard
[Current]
Cleanrooms and associated controlled environments, Part 1: Classification of air cleanliness by particle concentration
AS 2252 (series
Controlled environments
[Current]
High efficiency particulate air (HEPA) filters — Classification, construction and performance
Content history
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