Cleanrooms are classified by the cleanliness of their air. Up to now different countries have issued their own standards for measuring Clean Room cleanliness (e.g. Federal Standards 209e (USA) and BS 5259 (UK). The International Standard (ISO 14644) is being introduced in stages and the various country specific methods for the classification of cleanrooms are being superseded.
Currently approved ISO Standards are available for purchase from the International Organisation for Standardisation or British Standards Institute, as listed below:
 | ISO 14644-1: 1999 Cleanrooms and Associated Controlled Environments - Part 1: Classification of air cleanliness | ||
| ISO 14644-2: 2000 Cleanrooms and Associated Controlled Environments - Part 2: Specifications for testing and monitoring to prove continued compliance with IOS 14644-1 | ||
| ISO 14644-4: 2001 Cleanrooms and Associated Controlled Environments - Part 4: Design, construction and start-up | ||
NOTES ON BS EN ISO 14644:
| One or more sizes may be used as the considered particle size for classification. If unknown, 0.5 µm and 5.0 µm are suggested (both relevant in BS 5295, FS 209e and EU GMP). | ||
| Occupancy states must be quoted with options as follows: | ||
 | AS BUILT (no equipment, personnel or product. New or newly modified facility) | ||
| AT REST (equipment installed and operating as specified, no personnel present) | ||
| OPERATIONAL (equipment installed and operating with personnel present) | ||
| Minimum number of sample locations = A where A is the area of the facility in m2. For HLAC’s/VLAC’s the area is the cross section area perpendicular to the airflow. | ||
LINKS TO USEFUL INFORMATION:
The following links are external links. We are not responsible for the content of these websites.
United Kingdom Agencies and Government:
Medical Devices Agency
Medicines Control Agency
Pharmacopoeia for the UK
NHS Estates
NHS Estates Publications
British Standards Organisation (BSI)
Scottish Society for Contamination Control (S2C2)
COMPANIES:
Shield Medicare (Clean Room disposables and cleaning solutions)
Amercare (isolators)
DTR Medical
PBSC
INTERNATIONAL:
International Standards Organisation (ISO)
The Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-operation Scheme
U.S.A:
Department of Health and Human Services
Policy, research and Administrative Information
Food and Drug administration
Centre for Biologics Evaluation and Research
Centre for Devices and Radiological Health
Centre for Drug Evaluation and Research
Centre for Vetenary Medicine
FDAs Electronic FOIA Reading Room
FDA Field Operations
National Institutes of Health
Institutes, Centres and Divisions
NIH Guide for Grants and Contracts
Scientific Resources
U.S. National Library of Medicine
Other U.S Government Agencies
Agency for Health Care Policy and Research
Health Care Financing Agency
EUROPE:
EUCOMED (European Confederation of Medical Devices Associations)
European Medicines Agency
European Department for the Quality of Medicines
European Union National Regulatory Authorities.