Standard

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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

AS 1807.26-2004

[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

AS/NZS 3100:2022

[Current]

Approval and test specification - General requirements for electrical equipment

AS 60529-2004

[Current]

Degrees of protection provided by enclosures (IP Code)

AS/NZS 2107:2016

[Current]

Acoustics — Recommended design sound levels and reverberation times for building interiors

AS/NZS 2243.3:2022

[Current]

Safety in laboratories, Part 3: Microbiological safety and containment