Environmental Controls Procedure

The Environmental Controls Procedure establishes cleanroom controls and monitoring requirements for cleanroom or controlled manufacturing environment use and attributes that affect cleanroom performance.

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Supplied as one editable Microsoft Word document in a digital download.

Controlled-environment monitoring and response

It describes requirements for cleanrooms and controlled manufacturing environments under ISO 14644-1:2015 and ISO 14644-2:2015.

The procedure addresses environments where a defined cleanliness standard or other manufacturing control is required.

• Environmental risk assessment and product bioburden

• Temperature, humidity and positive-pressure controls

• Personnel practices, pest control and environmental monitoring records

Standards and frameworks addressed: ISO 14644-2:2015; ISO 13485:2016; FDA QMSR.

The document supports ISO 14644-1:2015, ISO 14644-2:2015, 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.

For sterile-load identification, inspection and final release, see the Sterile Load Preparation and Release Procedure. Both procedures are included in the Medical Device Sterilization Procedure Bundle.

For establishing the room, see the Cleanroom Design and Validation Procedure; for ongoing cleaning, see the Controlled Environment Cleaning Procedure. Both are included with this procedure in the Cleanroom Procedure Bundle. The Controlled Environment Gowning Procedure is a separately sold companion for 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 Medical Device Sterilization Procedure Bundle and Cleanroom Procedure Bundle. Explore the bundle for the related documents.