Standard
Track updates
AS 2252.5:2017
[Current]Controlled environments, Part 5: Cytotoxic drug safety cabinets (CDSC) — Design, construction, installation, testing and use
The objective of this Standard is to specify the basic requirements for cytotoxic drug safety cabinet (CDSC) design, construction, installation, testing and use.
Published: 27/07/2017
Pages: 34
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
Foreword
1 Scope
2 Application
3 Referenced documents
4 Definitions
5 General requirements
5.1 Classification of physical containment
5.2 Risk factors in assessing hazards
5.3 Primary barrier design
5.3.1 Work zone
5.3.2 Viewing window
5.3.3 Air barrier and containment of hazardous material within the CDSC
5.3.4 Controls
5.3.5 Design ergonomics and human factors
5.4 Secondary barrier design (Room)
5.4.1 Room requirements
5.4.2 Treatment of CDSC and room exhaust
6 Construction requirements for a CDSC
6.1 Outer shell
6.2 Work zone
6.2.1 General
6.2.2 Work access opening
6.2.3 Testing cover
6.2.4 Work zone illumination
6.2.5 Work floor
6.2.6 Working surface height
6.2.7 Sump
6.2.8 Grilles
6.2.9 Knee and foot space
6.3 Filters and filter installations
6.3.1 General
6.3.2 Prefilters
6.3.3 HEPA filters
6.3.4 Activated carbon filters
6.4 Blowers and alarm systems
6.4.1 Blowers
6.4.2 Blower monitoring and alarm systems
6.4.3 Access panels
6.4.4 Electrical services
6.5 Marking
7 Performance requirements for a CDSC
7.1 General
7.2 Critical performance tests for cabinet function
7.2.1 Filter installation integrity
7.2.2 Containment at the aperture
7.2.3 Work zone integrity
7.2.4 Air velocity and uniformity in the work zone
7.2.5 Alarm operational adjustment
7.2.6 Particle counts
7.3 Tests related to operator comfort and safety
7.3.1 General
7.3.2 Vibration
7.3.3 Sound level
7.3.4 Lighting
7.3.5 Ultraviolet radiation
8 Design and construction of a controlled environment for compounding cytotoxic drugs
8.1 General
8.2 Cleanroom enclosure
8.3 Facility layout
8.4 Dedicated HVAC services
8.4.1 General
8.4.2 Air filters
8.5 Cleanroom specifications
8.5.1 Room classifications
8.5.2 Temperature and humidity
8.5.3 Air change rates
8.5.4 Room pressures
8.6 Commissioning
8.7 Monitoring
8.8 Maintenance
8.8.1 General
8.8.2 Removal of HEPA filters
9 Operational use of a CDSC
9.1 Pre-operational measures
9.2 Vacuum equipment
9.3 Housekeeping and cleaning
9.3.1 General operations
9.3.2 Cleaning details
9.3.3 Contaminated waste collection and disposal
9.3.4 Spillage
9.3.5 Inactivators
9.3.6 Protective garments
9.3.7 Decontamination of equipment
9.4 Operation of a CDSC within a controlled environment
9.4.1 General
9.4.2 Unexpected failure of cabinet operation or in response to an alarm
Appendix A
A1 Scope
A2 Procedure
Appendix B
B1 Scope
B2 Procedure for cleaning a small spill within the CDSC
B3 Procedure for cleaning a large spill within the CDSC
Appendix C
C1 Scope
C2 Prions
C3 CDSC Safety improvements
C4 CDSC Usage
C5 Exhaust air discharge
C6 Performance requirements
C7 Cabinet cleaning
C8 Contaminated HEPA filter disposal
Appendix D
D1 General
D2 Cytotoxic drug safety cabinet quotation request (Purchaser to complete)
D3 Vendor response (Vendor to complete)
Cited references in this standard
[Superseded]
Cleanrooms, workstations, safety cabinets and pharmaceutical isolators — Methods of test, Method 26: Determination of air barrier containment of laminar flow safety cabinets — Potassium iodidediscus test
[Current]
Approval and test specification — General requirements for electrical equipment
[Current]
Acoustics — Recommended design sound levels and reverberation times for building interiors
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