Cleanroom Design and Validation Procedure
Use the Cleanroom Design and Validation Procedure to plan cleanroom design, installation and validation, from user requirements through DQ, IQ, OQ, PQ and certification.
Building a set? Buy procedures from the same family together and save: 5–9 for 20% off, 10–19 for 35%, 20–39 for 50%, or 40+ for 60%. The discount is applied automatically in your cart, or use Build Your QMS to choose and price a set.
Supplied as one editable Microsoft Word document in a digital download.
It guides development of a User Requirement Specification (URS) and qualification activities from concept through certification, including:
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
From requirements to certification
The procedure begins with a user requirement specification (URS) and preliminary design review. It then follows the cleanroom through design specifications, construction and formal design qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) and certification. The sequence helps a project team document why the selected environment meets the product and process requirements.
Controls after qualification
Later sections address environmental risk, product bioburden, temperature, humidity and pressure controls, along with monitoring and response activities. The document distinguishes the initial build and qualification work from the controls needed to keep the cleanroom suitable for use.
Standards and frameworks addressed: ISO 14644; ISO 13485:2016; FDA QMSR.
The document supports implementation of ISO 14644-1:2015, ISO 14644-2:2015, ISO 14644-4:2022, ISO 13485:2016 and FDA QMSR.
For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.
After qualification, use the Environmental Controls Procedure to document routine conditions and monitoring, and the Controlled Environment Cleaning Procedure for cleaning schedules and records. These three documents are included in the Cleanroom Procedure Bundle. The separately sold Controlled Environment Gowning Procedure covers personnel entry and dress.
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.
Part of a procedure bundle
This document is also included in Cleanroom Procedure Bundle. Explore the bundle for the related documents.
