The newly published ISO/TR 14644 TR 21 provides clarification on the application of sound airborne particle sampling techniques in support of ISO 14644-1:2015 for classification of cleanrooms and clean zones, and ISO 14644-2:2015 for airborne particle monitoring, to provide evidence of cleanroom performance related to air cleanliness by particle concentration.
It addresses a potential misinterpretation of the use of ISO 14644-1:2015, C.4.1.2 in informative Annex C, which suggests the use of limited tubing length for sampling macroparticles. This document also provides extra clarity on the use of the M Descriptor in ISO 14644-1:2015, Annex C, specifically in relation to consideration of >5,0 µm alongside ISO Class 5 (EU-PIC/S GMP Grade A and B at rest). It provides information on the uncertainty associated with sampling particles ≥5,0 µm and macro-particles, and steps to reduce that uncertainty.
Reviewed and discussed in this release are:
- for classification, the quality of the sample is the most important factor;
- for monitoring, the quality of the data is the most important factor;
- Sample tubing applications and limitations on the accuracy implications of using tubing at a significant or critical location;
- to reduce sampling loss in tubing, this tubing is as short and straight as possible;
- a sampling system is evaluated using a flow diagram to assess the impact of any tubing or valves used.
Learn more by listening to the contamination control podcast with Mark Hallworth, one of the committee members or reading the review paper.
Watch this on demand ISO 14644 TR 21 Webinar, with TR 21 committee member, Mark Hallworth.
Get the experts in Particle Measuring Systems’ Advisory team to do your risk assessment for tubing particle loss.
Particle loss in transport tubing can occur due to a combination of various external factors. To assess the risk and potential impact on the finished product, it is crucial to conduct particle transportation tests. The primary objective of these tests is twofold: first, to quantify the resultant particle losses within a remote sampling system, and second, to provide documented evidence characterizing the efficiency of viable and non-viable monitoring processes. By addressing these aspects, manufacturers can gain valuable insights into the particle transportation dynamics in their remote systems and ensure appropriate measures are taken to maintain product quality.
