Table of Contents

Abstract

Specifies requirements to provide control of airborne particulate contamination of levels appropriate for accomplishing contamination-sensitive actives. This Standard is identical with, and has been reproduced from, ISO 14644-4:2001.
RECONFIRMATION NOTICE
Technical Committee ME-060 has reviewed the content of this publication and in accordance with Standards Australia procedures for reconfirmation, it has been determined that the publication is still valid and does not require change.
Certain documents referenced in the publication may have been amended since the original date of publication. Users are advised to ensure that they are using the latest versions of such documents as appropriate, unless advised otherwise in this Reconfirmation Notice.
Approved for reconfirmation in accordance with Standards Australia procedures for reconfirmation on 23 December 2015.
Approved for reconfirmation in New Zealand on behalf of the Standards Council of New Zealand on 18 May 2016.
The following are represented on Technical Committee ME-060:
Airconditioning & Refrigeration Equipment Manufacturers Association of Australia
Auckland Regional Chamber of Commerce
Australian Chamber of Commerce and Industry
Australian Industry Group
CSIRO
Engineers Australia
Human Factors & Ergonomics Society of Australia
International Society for Pharmaceutical Engineering
Medical Technology Association of Australia
National Association of Testing Authorities Australia
NSW Health
Society of Hospital Pharmacists of Australia
Therapeutic Goods Administration

Scope

This part of ISO 14644 specifies requirements for the design and construction of cleanroom installations but does not prescribe specific technological or contractual means to meet these requirements. It i s i ntended for use by purchasers, suppliers and designers of cleanroom installations and provides a checklist of important parameters of performance. Construction guidance is provided, including requirements for start-up and qualification. Basic elements of design and construction needed to ensure continued satisfactory operation are identified through the consideration of relevant aspects of operation and maintenance.
NOTE Further guidance in respect of the above requirements is given in annexes A to H. Other parts of ISO 14644 may provide complementary information.
Application of this part of ISO 14644 is restricted in the following:
- user requirements are represented by purchaser or specifier;
- specific processes to be accommodated in the cleanroom installation are not specified;
- fire and safety regulations are not considered specifically; the appropriate national and local requirements should be respected;
- process media and utility services are only considered with respect to their routing between and in the different zones of cleanliness;
- regarding initial operation and maintenance, only cleanroom construction-specific requirements are considered.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Standards Australia
ProductNote	Reconfirmed 10/06/2016. This standard has been reconfirmed in Australia in 2016 and remains current in New Zealand. Reconfirmation Notice 10/06/2016
Pages
ISBN
Committee	ME-060
Supersedes	AS 1386.1-1989 AS 1386.4-1989 DR 02031 CP AS 1386.3-1989 AS 1386.2-1989