Understanding ISO 14644-2:2015 Cleanroom Monitoring
Following the recent publication of the revision of ISO 14644-1: 2015 and the paper on ISO 21501-4, Particle Measuring Systems PMS continues the series of ISO standards interpretation documents with the evaluation of the new ISO 14644-2: 2015 for Cleanroom Monitoring.
This document highlights the major changes in cleanroom monitoring, focusing on particle counters, between the previous version of ISO 14644-2 and the latest, second edition, dated December 12, 2015.
A specific approach of the best practices to be adopted for an efficient and compliant cleanroom monitoring process is discussed.
In combination with the revision of part 1. Classification of air cleanliness by particle concentration of ISO 14644-1: 2015, the technical committee of ISO TC 209 worked on updating the lines Basic guidelines for the monitoring of air cleanliness contained in ISO 14644-2.
The TC 209 community voted in favor of the revision to update and improve the standard specifically for:
- Simplify and clarify requirements and guidance tables that specify the frequency of cleanroom particle testing and monitoring used to demonstrate continued compliance with the cleanliness classification
Refine how these intervals can be extended, provided the automated monitoring systems show the cleanroom is under control
Provide new guidance on aspects to consider when setting up a cleanroom monitoring system
The introduction of the new standard also lists the objectives of ISO 14644-2, when successfully applied:
- Emphasize the needs and benefits of planned cleanroom contamination monitoring
- Provides the method for correct particle contamination alarm and setting of warning limits, based on careful evaluation of data trends
- Define the differences between a simple periodic cleanroom inspection and a more intensive / complex monitoring strategy
- Improve knowledge of the facility and processes, to improve risk assessment assessment and faster reaction to any unexpected cleanroom performance
- Concretely reduce operating costs by avoiding production losses
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Find out more about the requirements of Annex 1 on cleanroom monitoring
Particle Measuring Systems (PMS) has complete cleanroom contamination control solutions that meet all regulatory requirements, including ISO 14644-2 and EU GMP Annex 1, including:
- Our contamination control consulting services that can perform risk assessment for your pharmaceutical processes
- PMS Cleanroom particle counters including portable/mobile and fixed/remote
- Microbial monitors including portable / mobile, fixed / remote and single use
- Particle Measuring Systems Data Management Software
Particle Measuring Systems is direct to all major markets and able to provide the same ongoing support no matter where you are. Contact us today for a quote.
