AS 1079.

1—1993

Australian Standard

Packaging of items (sterile) for

patient care
Accessed by EDITH COWAN UNIVERSITY LIBRARY on 20 Jun 2016 (Document currency not guaranteed when printed)

Part 1: Selection of packaging

materials for goods undergoing
sterilization
 This Australian Standard was prepared by Committee PK/18, Packaging of Sterile
Goods. It was approved on behalf of the Council of Standards Australia on
4 August 1993 and published on 15 November 1993.

The following interests are represented on Committee PK/18:

Appita
Australian Chamber of Commerce and Industry
Australian Institute of Packaging
Commercial Services Group, N.S.W.
Department of Health, Housing and Community Services (Commonwealth)
Health Department, W.A.
Medical Industry Association of Australia
Accessed by EDITH COWAN UNIVERSITY LIBRARY on 20 Jun 2016 (Document currency not guaranteed when printed)

National Council of Chemical and Pharmaceutical Industries

Packaging Council of Australia
Plastics Industry Association
Queensland Health
South Australian Health Commission
Sterilizing Research and Advisory Council of Australia (N.S.W. Branch)

Review of Australian Standards. To keep abreast of progress in industry, Australian Standards are subject
to periodic review and are kept up to date by the issue of amendments or new editi ons as necessary. It is
important therefore that Standards users ensure that they are in possession of the latest edit ion, and any
amendments thereto.
Full detail s of all Australian Standards and related publi cati ons wil l be found in the Standards Australi a
Catalogue of Publi cati ons; this informati on is supplemented each month by the magazine ‘The Australi an
Standard’, which subscribing members receive, and which gives details of new publi cati ons, new edit ions
and amendments, and of withdrawn Standards.
Suggesti ons for improvements to Australian Standards, addressed to the head offi ce of Standards Australi a,
are welcomed. Notif ication of any inaccuracy or ambiguit y found in an Australi an Standard should be made
without delay in order that the matter may be investigated and appropriate action taken.

This Standard was issued in draft form for comment as DR 89108.

 AS 1079.1—1993

Australian Standard

Packaging of items (sterile) for

patient care
Accessed by EDITH COWAN UNIVERSITY LIBRARY on 20 Jun 2016 (Document currency not guaranteed when printed)

Part 1: Selection of packaging

materials for goods undergoing
sterilization

First publi shed as AS 1079— 1971.

Revised and redesignated AS 1079.1 — 1981.
Second editi on 1993.

PUBLISHED BY STANDARDS AUSTRALIA

(STANDARDS ASSOCIATION OF AUSTRALIA)
1 THE CRESCENT, HOMEBUSH, NSW 2140
ISBN 0 7262 8479 3
 AS 1079.1 — 1993 2

PREFACE

This Standard was prepared by the Standards Australia Committee on Packaging of Sterile
Goods under the direction of the Joint Multitechnics Standards Policy Board to supersede
AS 1079.1—1981, Packaging of items (sterile) for patient care, Part 1: Guide to selection
of packaging materials for goods undergoing sterilization .
This Standard is one of the AS 1079 series, which deals with packaging of items (sterile)
for patient care. The other Standards in the series are as follows:
Part 2: Non-reusable papers—For the wrapping of goods undergoing sterilization in
health care facilities
Part 3: Paper bags—For single use in health care facilities
Part 4: Flexible packaging systems—For single-use in hospitals
Non-reusable, non-woven wrapping materials—For goods undergoing
sterilization in health care facilities.*
In the preparation of this Standard, the Committee was conscious of growing
environmental concerns about the disposal of packaging materials. Aspects such as
recycling or disposal of the packaging materials after use are becoming more of an issue in
the selection of such materials.
This Standard differs principally from the 1981 edition in the following respects:
Accessed by EDITH COWAN UNIVERSITY LIBRARY on 20 Jun 2016 (Document currency not guaranteed when printed)

(a) Requirements for packaging material for use with the chosen method of sterilization
are now included.
(b) There is more emphasis on the packaging design.

* In course of preparation

 Copyri ght STANDARDS AUSTRALIA

Users of Standards are reminded that copyri ght subsists in all Standards Austr alia publi cati ons and software. Except where the
Copyri ght Act all ows and except where provided for below no publications or software produced by Standards Austr alia may be
reproduced, stored in a retr ieval system in any form or transmitt ed by any means without prior permission in writ ing from
Standards Australi a. Permission may be conditi onal on an appropriate royalt y payment. Requests for permission and information
on commercial software royalt ies should be directed to the head offi ce of Standards Austr alia.
Standards Austr alia wil l permit up to 10 percent of the technical content pages of a Standard to be copied for use
exclusively in-house by purchasers of the Standard without payment of a royalty or advice to Standards Austr alia.
Standards Austr alia wil l also permit the inclusion of its copyright material in computer soft ware programs for no royalty
payment provided such programs are used exclusively in-house by the creators of the programs.
Care should be taken to ensure that materi al used is from the current editi on of the Standard and that it is updated whenever the
Standard is amended or revised. The number and date of the Standard should therefore be clearly identif ied.
The use of materi al in print form or in computer software programs to be used commercially, with or without payment, or in
commercial contracts is subject to the payment of a royalty. This policy may be vari ed by Standards Austr alia at any ti me.
 3 AS 1079.1 — 1993

CONTENTS

Page

1 SCOPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2 REFERENCED DOCUMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
3 DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4 GENERAL REQUIREMENTS FOR PACKAGING MATERIAL . . . . . . . . . . . . . . 5
5 GENERAL REQUIREMENTS FOR PACKAGES . . . . . . . . . . . . . . . . . . . . . . . . . 5
6 REQUIREMENTS FOR PACKAGING MATERIALS AND PACKAGES FOR
SPECIFIC STERILIZATION PROCESSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
7 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Accessed by EDITH COWAN UNIVERSITY LIBRARY on 20 Jun 2016 (Document currency not guaranteed when printed)
 AS 1079.1 — 1993 4

STANDARDS AUSTRALIA

Australian Standard
Packaging of items (sterile) for patient care

Part 1: Selection of packaging materials for goods

undergoing sterilization

1 SCOPE This Standard specifies sterilization-related performance requirements to be

considered in the selection of packaging materials and packages intended for sterilization.
Packaging materials for pharmaceutical goods are not covered by this Standard.
NOTE: This Standard is not a code of sterilization practice. Furthermore, packaging materials
may additionally be subject to the requirements of other relevant parts of AS 1079 (see Preface).

2 REFERENCED DOCUMENTS The following documents are referred to in this

Standard:
AS
1410 Sterilizers—Steam—Pre-vacuum
Accessed by EDITH COWAN UNIVERSITY LIBRARY on 20 Jun 2016 (Document currency not guaranteed when printed)

1714 Sterilizers—12/88 ethylene oxide—Hospital use

1862 Aeration cabinets (for use with ethylene oxide sterilizers)
2182 Portable electrically heated steam sterilizers (downward displacement pressure
steam type)
2192 Sterilizers—Steam—Downward displacement
2400 Packaging
2400.1 Part 1: Glossary of packaging terms
2487 Dry heat sterilizers (hot air type)

3 DEFINITIONS For the purpose of this Standard, the definitions given in AS 2400.1
and those below apply.
3.1 Effective sterilization time—that period of time during which the least accessible part
of the load is subjected to the conditions necessary for the sterilization of that load.
3.2 Load—that quantity of packed product intended to be sterilized at the one time in one
sterilizing unit.
3.3 Package—the primary package intended to hold, restrain or enclose an item.
3.4 Packaging materials—those materials and components used in the construction of the
intended microbiological barrier.
3.5 Parameter—(in relation to sterilization) an entity which is given a quantitative value,
e.g. temperature, time.
3.6 Post-sterilization time—that period of time from the end of the effective sterilization
period to the removal of the load from the sterilization unit.
3.7 Pre-sterilization time—that period of time taken for the least accessible part of the
load to reach the condition necessary for effective sterilization.
3.8 Sterilization—the process of destruction of all forms of micro-organisms such that the
likelihood of a micro-organism surviving is reduced to the level of 10 −6.

COPYRIGHT
 5 AS 1079.1 — 1993

3.9 Sterilization cycle—combination of processes and parameters chosen to provide

sterilization. This is made up of ‘pre-sterilization’, ‘effective sterilization’ and
‘post-sterilization’.

4 GENERAL REQUIREMENTS FOR PACKAGING MATERIAL Packaging

materials for use with the chosen method of sterilization shall—
(a) be capable of being formed, closed and sealed into a package;
(b) allow the enclosed goods to be sterilized;
(c) be compatible with the contents under the chosen method of sterilization;
(d) be capable of withstanding the conditions of the selected sterilization cycle without
either an adverse effect on the performance of the package or deleterious effect on
the goods being sterilized; and
(e) act as a microbiological barrier adequate to maintain the sterility of the sterilized
product throughout the intended shelf life.
NOTES:
1 To maintain a sterile product throughout the intended shelf life, both packaging materials and
primary packages need to be effective microbial barriers. Generally, the items under test
should be subjected to a microbial challenge under conditions of stress considered likely for
that particular type of package.
Because it is not possible to directly correlate the physical properties of the packaging
Accessed by EDITH COWAN UNIVERSITY LIBRARY on 20 Jun 2016 (Document currency not guaranteed when printed)

material or package with microbial penetration of them by the currently available test
methods, no one single method of test can be standardized and considered to be the best. To
establish reliable guidelines, comparative studies involving more than one test for any one
particular packaging system should be carried out.
2 Sterilizers and auxiliary equipment for hospital use are described in AS 1410, AS 1714,
AS 1862, AS 2182, AS 2192 and AS 2487.
Manufacturers should be able to demonstrate that the toxicological aspects of the materials
are appropriate to the application.

5 GENERAL REQUIREMENTS FOR PACKAGES The sealed package shall—

(a) permit the sterilization of the contents;
(b) protect the contents prior to, during and after sterilization and subsequent normal
handling, transport and storage;
(c) maintain the sterility of the contents throughout the intended shelf life, unless
damaged or opened; and
(d) allow the packaged goods to be aseptically removed from the pack.

6 REQUIREMENTS FOR PACKAGING MATERIALS AND PACKAGES FOR

SPECIFIC STERILIZATION PROCESSES
6.1 General Sterilization-related requirements for packaging materials and packages,
specific to four common sterilization processes, are set out in Clauses 6.2 to 6.5.
6.2 Saturated steam under pressure
NOTE: The permeability of some packaging materials may change during the steam sterilization
process in such a manner as to retard the egress of steam or condensate from the package.
Packaging materials and packages selected for sterilization by saturated steam under
pressure shall—
(a) allow the transfer of heat and passage of air and steam in and out of the package
during the sterilization cycle;

COPYRIGHT
 AS 1079.1 — 1993 6

(b) withstand the hot and moist conditions existing at various times during the
sterilization cycle while maintaining both the physical integrity and microbiological
properties of the package;
(c) withstand temperatures between 121°C and 136°C for periods up to 60 min; and
(d) withstand sudden increases or decreases of pressure occurring where pre-vacuum
sterilizers are used.
NOTES:
1 Particular attention needs to be paid to the packaging seal in respect to this requirement.
2 The process conditions quoted are given as examples of the sterilization conditions to which
packaging materials may be subjected. The suitability of a potential packaging material for a
particular sterilization process under specific circumstances should be determined. However,
materials should, at least, be capable of withstanding a common sterilization temperature of
121°C for a minimum of 15 min.
6.3 Ethylene oxide
NOTES:
1 The permeability of some packaging materials may change during the ethylene oxide
sterilization process in such a manner as to retard the egress of ethylene oxide and its
derivatives from the package.
2 Care should be taken during the selection of the packaging materials to consider the possible
formation of potentially hazardous materials by reaction of the materials with the sterilizing
Accessed by EDITH COWAN UNIVERSITY LIBRARY on 20 Jun 2016 (Document currency not guaranteed when printed)

gas.
Packaging materials and packages selected for sterilization by ethylene oxide shall—
(a) allow the transfer of heat and passage of air, water vapour, ethylene oxide and its
derivatives in and out of the package during the sterilization cycle and during any
subsequent aeration treatment;
(b) allow the removal of ethylene oxide and its derivatives to a safe level from the
sterilized goods, the interior of the pack and the packaging material itself;
(c) withstand the various combinations of time, temperature, relative humidity and
ethylene oxide concentrations necessary for sterilization of the contents, while
maintaining their physical integrity and microbiological barrier properties; and
(d) withstand sudden changes of pressure occurring when vacuum-type sterilizers are
used.
NOTE: Particular attention needs to be paid to the packaging seal in respect to this requirement.
6.4 Dry heat Packaging materials and packages selected for sterilization by dry heat
shall—
(a) allow penetration of heat to the contents of the package during the sterilization cycle;
and
(b) withstand the appropriate dry heat sterilization cycles as detailed in the BP.
NOTE: Particular attention needs to be paid to the packaging seal in respect to this requirement.
Furthermore, the packaging material shall be stable when subjected to sterilization, and
shall not give off fumes or residues which may cause an explosion or adversely effect the
product.
NOTE: Some materials may degrade at elevated temperatures, especially where dry heat
sterilization cycles are prolonged, e.g. embrittlement of paper, melting of certain plastic
materials.
6.5 Ionizing radiation Packaging materials and packaging selected for sterilization by
ionizing radiation shall allow the penetration of ionizing radiation to the contents of the
package during the sterilization cycle.

COPYRIGHT
 7 AS 1079.1 — 1993

NOTES:
1 All products and packaging materials should be carefully checked to ensure their stability at
the doses to which they are likely to be exposed during sterilization by ionizing radiation.
2 It should be noted that, after irradiation, mechanical properties may not all change by the
same relative amount. Tensile strength of some materials may increase, while impact strength
may decrease.
The stability of different materials has been described by the Isotope Division of the Atomic
Energy Research Establishment, Berks, U.K.
3 References 1-6 (see Clause 7) provide further information on the radiation stability of
packaging materials.

7 REFERENCES
1 PLESTER, D.W. The effects of radiation sterilization on plastics. In BRIGGS
PHILLIPS, G. and MILLER, W.S., Eds. Industrial sterilization . Durham N.C., U.S.A.,
Duke University Press, 197, pp. 141-152.
2 CRAWFORD, C.G. Sterile single use medical products; Material and packaging
aspects. Nord-Emballage. Vol.3, 1970, p. 32.
3 KILLORAN, J. J. Chemical and Physical Changes in Food Packaging Materials
Exposed to Ionizing Radiation . Radiation Research Reviews. Vol.3, 1972, p.369-p.388.
4 Radiation Stability of Materials. Radioisotope Review Sheet. WANTAGE RESEARCH
Accessed by EDITH COWAN UNIVERSITY LIBRARY on 20 Jun 2016 (Document currency not guaranteed when printed)

LABORATORY, United Kingdom Atomic Energy Authority, March 1965.

5 CHARLESBY, A. Atomic Radiation and Polymers, Pergamon, 1960, Oxford, U.K.
6 The Sterilisation of Plastics by Gamma Radiation (Bibliography) (Unpublished).
MEDICAL ENGINEERING RESEARCH ASSOCIATION. Copies available on request
from Medical Industry Association of Australia P.O. Box 497 Roseville N.S.W. 2069
Tel (02) 415 1151.

COPYRIGHT
Accessed by EDITH COWAN UNIVERSITY LIBRARY on 20 Jun 2016 (Document currency not guaranteed when printed)

This page has been left intentionally blank.