Cleanroom Procedure Bundle
The Cleanroom Procedure Bundle includes: Cleanroom Design and Validation Procedure; Environmental Controls Procedure; and our Cleanroom Cleaning Procedure. The procedures provide valuable guidance on the cleanroom installation, validation, monitoring and controls, and routine cleanroom cleaning practices.
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Cleanroom Procedure Bundle
The Cleanroom Procedure Bundle includes procedures that govern; the development of a user requirement specification (URS), cleanroom design, installation, and validation (DQ,IQ,OQ,PQ); cleanroom monitoring and controls, and cleanroom cleaning practices.
Cleanroom Procedure Bundle - Overview
The Cleanroom Procedure Bundle includes the following procedures:
Cleanroom Design and Validation Procedure -The Cleanroom Design and Validation Procedure governs the design, build and validation of cleanrooms in accordance with ISO 14644-1:2015, ISO 14644-2:2015, and ISO 14644-4:2022 and other applicable standards and regulations.
Environmental Controls Procedure -The Environmental Controls procedure establishes controls for personnel and gowning, monitoring plan for viable and non-viable particulate, temperature and humidity, pressure differential, bioburden, and more per ISO 14644-1:2015 and ISO 14644-2:2015.
Controlled Environment Cleaning -The Controlled Environment Cleaning Procedure establishes routine cleanroom cleaning requirements for daily, weekly, monthly and yearly cleaning and controlled environment care.
