Acquisition of Standards, Recommended Practices, Books and Journals

European Union and USA Guides to Good Manufacturing Practice

The European Union Guide to Good Manufacturing Practice (EU GGMP)

This can be downloaded free from the Internet at the following address: http://pharmacos.eudra.org. It is contained in the 'Unit F2 Pharmaceuticals' section under the heading 'EudraLex Collection Vols. 1-9'. Volume 4 is the correct document. Remenber to download Annexe 1.

'Guideline on Sterile Drug Products Produced by Aseptic Processing'

This can be downloaded free from the FDA Centre for Drug Evaluation and Research at http://www.fda.gov
/cder/guidance/5882fnl.pdf

www.fda.gov After opening the FDA site you should click on to 'Drugs'. The document is available, at the time of writing, in their 'Regulatory Guidance' section where it may be found in the 'Guidance Documents Web Page' under the 'Compliance' heading.

Recommended Practices and Guides of the Institute of Environmental Sciences and Technology (IEST)

The IEST in the USA produces a large number of Recommended Practices (RPs) and Guides that cover many cleanroom topics and are an invaluable source of information. To obtain information about the contents of IEST Recommended Practices and Guides and how to purchase them -

Cleanroom Journals and Magazines

Free distribution

The following magazines are distributed free of charge. However, this free circulation may be restricted to the country of publication, and to individuals that the magazine publishing companies consider to have bona fide cleanroom credentials. Please visit their web site to view samples of their magazines and contact them.

A2C2 - The Journal of Advancing Applications in Contamination Control
www.a2c2.com

This publication is published monthly and produced by A2C2 in the USA 

CleanRooms
www.cleanrooms.com

Cleanrooms is monthly magazine produced by CleanRooms in the USA 

The Monitor
www.s2c2.co.uk

This is the newsletter of S2C2 that is published three times a year 

Journals and magazines available on subscription

 
Journal of the Institute of Environmental Sciences and Technology
www.iest.org

This is available to members of IEST, or by subscription. It covers a wider field of interest than cleanrooms but usually has at least one article about cleanroom related issues in each issue of this journal 

Cleanroom Technology
www.cleanroom-technology.co.uk

This publication is published monthly by Angel Business Communications in the UK 

European Journal of Parenteral & Pharmaceutical Sciences
www.euromed.uk.com/
jatr/ejppsjournal/ejpps.htm

This is a quarterly journal published by the Parenteral Society in the UK and is the official journal of the European Sterile Products Confederation (ESPC). It usually has articles concerned with contamination control in pharmaceutical manufacturing 

PDA Journal of Parenteral Science
www.pda.org
The Parenteral Drug Association (PDA) in the USA publishes this journal. It usually has articles concerned with contamination control in pharmaceutical manufacturing 

 

International Organization for Standards (ISO) Standards

The ISO is preparing a range of cleanroom standards. Follow this link to find their present status.

Some ISO standards are available for purchase through S2C2. A discounted price is given to our members. For current price and availability of ISO standards -

s2c2 shop

Cleanroom Books

The following books are available from the S2C2 Bookshop usually at a discount price to members -

Title / Author

Publisher
"Risk Management of Contamination (RMS) during Cleanroom Manufacture", Technical Monograph No. 14 (ISBN No. 1-905271-12-3) by W Whyte, University of Glasgow, Scotland, UK and T Eaton, AstraZeneca, Macclesfield, UK.
 A joint publication with the Parenteral Society

This is a joint publication of S2C2 and the Parenteral Society and is published as a monograph and based on the authors' four recent publications in the European Journal of Parenteral and Pharmaceutical Science.   These four papers discuss Risk Management and Risk Assessment as applied to microbial contamination during cleanroom manufacturing.   In this monograph the publications have been combined, updated and additional information added.
Cleanroom Design (second edition) edited by Whyte, W. (1999)
 Published by Wiley, Chichester, UK. ISBN. 0-471-94204-9
(322 pages)

Written by an international group of authors, this book considers the factors to be taken into account when designing cleanrooms. Three chapters describe how cleanrooms are designed for the principal manufacturing areas of microelectronics, pharmaceutics and biotechnology. Other subjects covered are international design standards, the economics of cleanroom design, high efficiency air filtration, materials used in cleanroom construction, and the provision of clean gases and water.

For further information click here.
Cleanroom Technology -Fundamentals of Design, Testing and Operation by W Whyte (2001)

Published by Wiley, Chichester, UK. ISBN 0-471-86842-6

(296 pages)

This book covers the three main facets of cleanroom technology, namely: cleanroom design, cleanroom testing and the operation of cleanrooms. It is intended for anyone who wishes an overview of the fundamentals of cleanrooms, or who needs a text book to help them teach 'Cleanroom Technology' to their cleanroom personnel.

For further information click here.
Introduction to Contamination Control and Cleanroom Technology by Ramstorp, M. (2000)
 Published by Wiley-VCH. ISBN 3-527-30142-9
(168 pages)

This textbook is intended as an introduction to the area of contamination control but is also a good source of knowledge for people with both theoretical and practical background. It covers the basic principles of contamination control and cleanroom technology from an holistic point of view. It deals with cleanliness and hygiene and their impact on the outcome of a process. The topics discussed reflect results from both scientific as well as practical points of view.