ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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ISO (International Standards Organization) 14644 and 14698

The Institute of Environmental Sciences and Technology (IEST) is the Secretariat for Technical Committee 209 of the International Standards Organization (ISO/TC 209), charged with writing a series of international standards for cleanrooms and associated controlled environments.



International Cleanrooms and Associated Controlled Environments Standard ISO 14644 consists of the following parts:

1. 14644-1: Cleanrooms and associated controlled environments – Part 1: Classification and cleanliness

2. 14644-2: Cleanrooms and associated controlled environments – Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1

3. 14644-3: Cleanrooms and associated controlled environments – Part 3: Test methods

4. 14644-4: Cleanrooms and associated controlled environments – Part 4: Design, construction and start-up

5. 14644-5: Cleanrooms and associated controlled environments – Part 5: Operations

6. 14644-6: Cleanrooms and associated controlled environments – Part 6: Vocabulary

7. 14644-7: Cleanrooms and associated controlled environments – Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)

8. 14644-8: Cleanrooms and associated controlled environments – Part 8: classification of airborne molecular contamination



International Cleanrooms and Associated Controlled Environments Standard ISO 14698 consists of the following parts:

1. 14698-1: Cleanrooms and associated controlled environments – Biocontamination control – Part 1: General principles and methods

2. 14698-1: Cleanrooms and associated controlled environments – Biocontamination control – Part 2: Evaluation and interpretation of biocontamination data

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