As 2639-1994 Laminar Flow Cytotoxic Drug Safety Cabinets - Installation and Use
As 2639-1994 Laminar Flow Cytotoxic Drug Safety Cabinets - Installation and Use
Australian Standard
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Australian Standard
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PREFACE
This Standard was prepared by the Joint Australia / New Zealand Standards Committee on
Controlled Environment to supersede AS 2639— 1983, Cytotoxic drug safety
cabinets—Installation and use. It satisfies the need for a guide to the installation and use
of the cytotoxic drug safety cabinets specified in AS 2567, Laminar flow cytotoxic drug
safety cabinets .
The Standard recognises four stages of physical containment provided by the following
barriers:
(a) Primary barriers provide immediate containment at the source. In this Standard, the
cytotoxic drug safety cabinet is the primary barrier.
(b) Secondary barriers provide containment in the event of failure of the primary barrier
or a spill outside the primary barrier. An example of a secondary barrier is the room
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(and its support facilities) within which the primary barrier is located.
(c) Tertiary barriers are buildings in which the secondary barriers are housed.
(d) Quaternary barriers are the geographical sites for buildings constituting the tertiary
barriers. An example of a quaternary barrier is an island.
Further advice and recommendations about practices relating to laminar flow cytotoxic
drug safety cabinets may be found in the Therapeutic Goods Administration’s Bulletin
No. 3. To obtain copies of this bulletin contact the Therapeutic Goods Administration, PO
Box 100, Woden, ACT.
This edition is essentially an update reflecting current technology and policies with
editorial amendments to refer to other current Standards and authorities.
The terms ‘normative’ and ‘informative’ have been used in this Standard to define the
application of the appendix to which they apply. A ‘normative’ appendix is an integral
part of a Standard, whereas an ‘informative’ appendix is only for information and
guidance.
CONTENTS
Page
FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
APPENDICES
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BIBLIOGRAPHY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
AS 2639— 1994 4
FOREWORD
(e) Protection of the surrounding environment and of those personnel not involved in
the preparation and use of these drugs.
Cabinet installations, which provide a lesser degree of environmental and containment
control than that specified in this document, may not provide an adequate level of
protection for personnel and drug products. In particular, the air barrier at the cabinet
work opening is vulnerable to disruption by air movements produced by personnel near
the cabinet, room ventilation systems, and the opening and closing of doors. Such air
movements can cause temporary failure of the cabinet to contain aerosols of drug
products. Additionally, operation of the cabinet in a room which does not provide Class
350 air cleanliness may result in premature blockage of the cabinet exhaust filter and a
reduced level of personnel and product protection.
The Australian concept of cabinets which operate independently of other air-handling
systems is in contrast to that of some other countries, where the cabinet exhaust may be
directly connected to a ducted system that discharges to atmosphere. However, direct
connection in this way can allow the exhaust system to influence cabinet airflows, with
consequent failure of air barrier containment. This Standard specifies a means of
entraining cabinet exhaust air into the room exhaust system without a direct connection,
thereby minimizing any external influence on cabinet performance.
5 AS 2639 — 1994
STANDARDS AUSTRALIA
Australian Standard
Laminar flow cytotoxic drug safety cabinets—Installation and use
1 SCOPE This Standard sets out recommended practices for the installation, operation,
maintenance, decontamination and inspection of open-fronted laminar flow cytotoxic drug
safety cabinets as specified in AS 2567.
NOTE: Although the cabinets are intended specifically for handling injectable cytotoxic drugs,
they may have wider application in the handling of other hazardous drugs and materials. These
applications may require additional precautions.
Standard:
AS
1324 Air filters for use in air conditioning and general ventilation
1339 Code of practice for manual handling of materials
1386 Cleanrooms and clean workstations
1386.1 Part 1: Principles of clean space control
1386.3 Part 3: Non-laminar flow cleanrooms—Class 350 and cleaner
1470 Health and safety at work— Principles and practices
1807 Cleanrooms, workstations and safety cabinets—Methods of test
1837 Ergonomics in factory and office work
2013 Cleanroom garments
2013.1 Part 1: Product requirements
2567 Laminar flow cytotoxic drug safety cabinets
4 SECONDARY BARRIER
4.1 General The secondary barrier shall be a cleanroom set aside exclusively for
housing the cytotoxic cabinet.
This room shall be designed to facilitate asepsis in the handling and preparation of
cytotoxic drugs. The room shall also be designed to provide containment of cytotoxic
drugs particularly in the event of the failure of the cytotoxic drug safety cabinet or a
spillage outside the cabinet. A suitable arrangement of the room is shown in Figure 1.
4.2 Asepsis To facilitate asepsis, the room housing the cytotoxic drug safety cabinet
shall be a Class 350 cleanroom in accordance with AS 1386.3 as varied by the
requirements of this Standard.
Asepsis is facilitated by the following:
(a) The maintenance of pressure differentials between the room and the anteroom, and
the anteroom and the adjacent areas which minimizes the passage of air and hence
airborne particulate matter from the adjacent areas into the room.
COPYRIGHT
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