DIN EN ISO 14644-5:2025: Updated Standard for Cleanroom Operations
The revised ISO 14644-5:2025 “Cleanrooms and Associated Controlled Environments – Part 5: Operations” replaces the previous 2005 edition. It sets out the basic requirements for planning, operating and controlling cleanrooms, as referenced in regulations such as EU GMP Annex 1.
The most significant change is the introduction of a recommended Operations Control Programme (OCP) – a documented management system linked to the Contamination Control Strategy (CCS).
The OCP provides a structured framework to demonstrate that cleanrooms and HVAC systems are operated in compliance with defined cleanliness grades. It integrates material and personnel flow diagrams, operational and maintenance procedures, cleaning and disinfection plans, monitoring programmes, and maintenance schedules, offering a comprehensive view of cleanroom operations.
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