Cleanroom Procedure Bundle
The Cleanroom Procedure Bundle brings together cleanroom design and validation, environmental controls and controlled-environment cleaning. Together, the procedures cover user requirements and qualification, monitoring of the operating environment, and documented cleaning practices.
Supplied as three editable Microsoft Word documents in a digital download.
Cleanroom qualification, monitoring and cleaning
Cleanroom Design and Validation Procedure: user requirements, design, installation and DQ, IQ, OQ and PQ qualification, addressing ISO 14644-1:2015, ISO 14644-2:2015 and ISO 14644-4:2022.
Environmental Controls Procedure: personnel and gowning controls, plus monitoring of viable and non-viable particles, temperature, humidity, pressure differential and bioburden.
Controlled Environment Cleaning Procedure: routine cleaning schedules and records for the controlled environment.
Use the documents together to connect initial qualification with monitoring and ongoing cleaning practices.
Need a separate entry and personnel gowning workflow? See the separately sold Controlled Environment Gowning Procedure; it is not one of the three documents in this bundle.
Individual documents in this bundle
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Medical Device Cleanrooms: Qualification, Monitoring, Cleaning and Gowning for workflow guidance, a checklist and common mistakes.
