Sterilization, Cleanrooms and Packaging
ISO 14644: Cleanrooms and Controlled Environments
ISO 14644 is a multi-part standard for cleanrooms and associated controlled environments. It defines cleanliness classes by airborne particle concentration and covers how rooms are tested, monitored, designed, built and operated.
At a Glance
- Standard
- ISO 14644
- Subject
- Cleanrooms and Controlled Environments
- Group
- Sterilization, Cleanrooms and Packaging
- Industries
- 1 industry guides reference it
A plain-language summary of scope, not the standard itself. Buy the current edition from the publisher and check which edition your auditor or market expects.
What It Covers
The classification part sets ISO classes based on the concentration of airborne particles at specified sizes, along with the method for sampling and counting them. A room or zone is classified in a stated occupancy state, such as as-built, at-rest or operational, and that state matters whenever results are compared.
Other parts cover monitoring to show the room continues to meet its class, test methods for airflow, pressure differential, filter leakage and recovery, design and construction, and cleanroom operations. Device manufacturers use them to build a monitoring program proportionate to the risk to product.
Particle classification isn't the whole picture. ISO 14644 classes are based on particles, not microorganisms, so a device maker still needs to justify which class each process needs, control microbial contamination where it matters, and connect environmental data to product risk and bioburden.
Who It Applies To
- Manufacturers assembling or packaging devices in cleanrooms
- Sterile and aseptic device and combination product sites
- Contract manufacturers offering cleanroom assembly
- Facilities teams designing or requalifying controlled environments
What Auditors Check
Classification Records
Current classification reports, the occupancy state tested and the sampling locations used.
Monitoring Plan
A documented plan with locations, frequency, limits and the rationale behind each.
Excursions and Trends
Investigations of out-of-limit results, and trending that catches slow drift before it becomes an excursion.
Pressure and Airflow
Pressure differential monitoring between zones, with alarms and responses defined in advance.
Gowning and Behavior
Gowning procedures, training and observed practices that match the class the room claims.
Link to Product Risk
A rationale tying each area's class to product and process risk, including microbial controls where needed.
Related Services
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
Supplier Audits and Supplier Controls
Risk-based supplier selection, quality agreements, monitoring and supplier audits that hold up under QMSR.
CAPA System Remediation
Fixing a CAPA system auditors keep citing: the procedure, the records, root cause, effectiveness and backlog.
Industry Guides That Reference ISO 14644
ISO 14644
Check Your Quality System Against ISO 14644
An AI-assisted first pass maps your existing documents against the requirements in scope, and an advisor reviews every result. Please don't send confidential documents yet: secure upload is set up after onboarding.
