AS 4273—1999

(Incorporating Amendment No. 1)

AS 4273

Australian Standard™
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Design, installation and use of

pharmaceutical isolators
 This Australian Standard was prepared by Committee ME/60, Controlled
Environment. It was approved on behalf of the Council of Standards Australia on
31 December 1998 and published on 5 March 1999.

The following interests are represented on Committee ME/60:

Air-Conditioning & Refrigeration Equipment Manufacturers
Auckland Regional Chamber of Commerce
Australian Chamber of Commerce and Industry
Australian Contamination Control Society
Australian Industry Group
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Australian Institute of Refrigeration Air Conditioning and Heating

Australian Pharmaceutical Manufacturers Association
Australian Society for Microbiology
Commonwealth Department of Health and Family Services
CSIRO — Division of Animal Health
Department of Human Services, Vic.
Medical Industry Association of Australia
Ministry of Health, New Zealand
National Association of Testing Authorities Australia
N.S.W. Health Department
Society of Hospital Pharmacists of Australia

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This Standard was issued in draft form for comment as DR 98018.

 AS 4273—1999
(Incorporating Amendment No. 1)

Australian Standard™
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

Design, installation and use of

pharmaceutical isolators

Originated as AS/NZS 4273(Int):1995.

Revised and designated AS 4273 — 1999.
Reissued incorporating Amendment No. 1 (May 2000).

COPYRIGHT
© Standards Australia International
All rights are reserved. No part of this work may be reproduced or copied in any form or by
any means, electronic or mechanical, including photocopying, without the written
permission of the publisher.
Published by Standards Australia International Ltd
PO Box 1055, Strathfield, NSW 2135, Australia
ISBN 0 7337 2510 4
 AS 4273 — 1999 2

PREFACE

This Standard was prepared by the Joint Standards Australia/Standards New Zealand
Committee ME/60, Controlled Environment to supersede AS/NZS 4273(Int):1995,
Guidelines for the design, installation and use of pharmaceutical isolators. This Standard
is the result of a consensus among representatives on the Joint Committee to produce it as
an Australian Standard.
This Standard incorporates Amendment No. 1 (May 2000). The changes required by the
Amendments are indicated in the text by a marginal bar and amendment number against
the clause, note, table, figure, or part thereof affected.
This Standard provides design requirements and guidance for the construction of
pharmaceutical isolators, recommendations for the environment in which they are to be
used, performance requirements and guidance on their installation and use. Possible uses
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of isolators include the preparation of products which require a high level of assurance of
protection from contamination and the preparation of products which are agents presenting
a potential hazard to the operator and the environment.
This document has its origins in one prepared by a working party formed by the Regional
Quality Control Pharmacists Subcommittee of the Regional Pharmaceutical Offices (UK).
Permission to utilize this document is gratefully acknowledged.
The term ‘informative’ has been used in this Standard to define the application of the
appendix to which it applies. An ‘informative’ appendix is only for information and
guidance.
 3 AS 4273 — 1999

CONTENTS
Page

FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1 SCOPE . . . . . . . . . . . . . . . . . ........................ . . . . . . . . . . . . 5
2 OBJECTIVE . . . . . . . . . . . . . ........................ . . . . . . . . . . . . 5
3 REFERENCED DOCUMENTS ........................ . . . . . . . . . . . . 5
4 DEFINITIONS . . . . . . . . . . . ........................ . . . . . . . . . . . . 6
5 DESIGN PRINCIPLES . . . . . . ........................ . . . . . . . . . . . . 7
6 PERFORMANCE . . . . . . . . . ........................ . . . . . . . . . . . . 9
7 LABELLING . . . . . . . . . . . . ........................ . . . . . . . . . . . . 9
8 SITING OF ISOLATORS . . . . ........................ . . . . . . . . . . . . 9
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9 PHYSICAL, OPERATOR AND ENVIRONMENTAL CONTROL

AND MONITORING . . . . . . . ........................ . . . . . . . . . . . . 10

APPENDICES
A PURCHASER-SUPPLIER LIAISON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
B STATUTORY AUTHORITIES FOR RADIATION SAFETY . . . . . . . . . . . . . 18
C GUIDELINES FOR OPERATOR TRAINING . . . . . . . . . . . . . . . . . . . . . . . 20
D GLOVES AND GAUNTLETS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
E SUMMARY CERTIFICATE OF COMMISSIONING AND
ROUTINE RECERTIFICATION TO AS 4273 . . . . . . . . . . . . . . . . . . . . . . . 22
 AS 4273 — 1999 4

FOREWORD

Pharmaceutical isolators are designed to allow individual aseptic transfers to be conducted

in a Class 3.5 environment without direct access by the operator and without contact with
their external environment. Pharmaceutical isolators potentially provide the equivalent of
a laminar flow cabinet operating within a controlled secondary environment. Thus they
remove the need for operators to wear sterile cleanroom garments and introduce the
possibility of a lower standard of environment in the room in which the device is sited.
Type 1 Pharmaceutical isolators are designed primarily for protection of the product, for
example sterile infusions. Type 2 Pharmaceutical isolators are designed for protection of
the product, such as cytotoxic drug injections, but are also intended to provide
protection —
(a) to the operator;
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(b) to the environment; and

(c) to isolator service personnel to an extent equivalent to that provided by devices
complying with AS 2567, Laminar flow cytotoxic drug safety cabinets.
The type of isolator, the class of transfer device and the intended application will
influence the degree of cleanness of the background environment in which the isolator
should be located. This Standard addresses this issue. In addition, when selecting or
designing, locating, installing and using an isolator, consideration should be given to
safety aspects of the handling of starting materials and components, surface disinfection
of components and disposal of waste generated during use. The vendor should classify the
isolator according to type and the purchaser should locate it according to end use.
The major advantage of isolators is that they constitute a self-contained working
environment with annexed transfer facilities. Another advantage is that they can be
custom-built for a defined purpose or service. Customization can include variations in
size, configuration, materials of construction, inbuilt devices, air flows and pressure
differentials. For this reason a highly detailed specification for their construction is
impractical and would be restrictive. The present Standard therefore avoids this detail.
 5 AS 4273 — 1999

STANDARDS AUSTRALIA

Australian Standard
Design, installation and
use of pharmaceutical isolators

1 SCOPE This Standard gives design requirements and guidance for the construction
of pharmaceutical isolators, recommendations for the environment in which they are to be
used, performance requirements and guidance relating to their installation and use. It does
not refer to flexible film or hybrid isolators or to devices intended to be used for handling
of pathogenic organisms.
NOTE: Appendix A provides guidance on information that should be discussed between
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purchaser and supplier.

2 OBJECTIVE The objective of this Standard is to contribute to the safety of patients,

operators, the environment and the integrity of materials handled by providing an isolated
Class 3.5 controlled work space for individual aseptic transfers which is connected to
suitable transfer facilities, located in an appropriate immediate environment and which
utilizes appropriate containment principles where hazardous substances are being handled.

3 REFERENCED DOCUMENTS The following documents are referred to in this

Standard:
AS
1324 Air filters for use in general ventilation and airconditioning
1324.2 Part 2: Methods of test
1386 Cleanrooms and clean workstations
1386.1 Part 1: Principles of clean space control
1807 Cleanrooms, workstations and safety cabinets — Methods of test
1807.1 Part 1: Determination of air velocity and uniformity of air velocity in
clean workstations and laminar flow safety cabinets
1807.2 Part 2: Determination of performance of clean workstations and laminar
flow safety cabinets under loaded filter conditions
1807.5 Part 5: Determination of work zone integrity
1807.6 Part 6: Determination of integrity of terminally mounted HEPA filter
installations
1807.7 Part 7: Determination of integrity of HEPA filter installations not
terminally mounted
1807.8 Part 8: Particle counting in work zone by automatic particle counter
1807.10 Part 10: Determination of air pressure of cleanrooms
1807.15 Part 15: Determination of illuminance
1807.20 Part 20: Determination of sound level at installed workstations and safety
cabinets
1807.24 Part 24: Determination of recovery times of cleanrooms
1807.25 Part 25: Determination of gas tightness of outer shell of biological safety
cabinets
2567 Laminar flow cytotoxic drug safety cabinets
2639 Laminar flow cytotoxic drug safety cabinets — Installation and use

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AS 4273-1999, Design, installation and use of

pharmaceutical isolators
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