ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Operational (Cleanroom)

Condition where the installation is functioning in the specified manner, with the specified number of personnel present and working in the manner agreed upon”. ISO 14644-1, ISO 14644-3, ISO 14644-5, ISO 14698-1.

Publication Source: ISO/TC209 Working Groups at 2001-03-31 – Committee Draft ISO/CD 14644-6 “Cleanrooms and associated controlled environments” – Part 6: Terms and Definitions

See also: As-Built (Cleanroom) At-Rest (Cleanroom)

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