ISO 14644-1:2015 Frequently Asked Questions (FAQs)

The newly updated ISO14644-1:2015 has caused some confusion and raised concerns by companies who want to ensure that they are fully compliant. To address these issues, Particle Measuring Systems is sharing our industry expertise and have provided an ISO 14644-1:2015 summary paper, an on-demand webinar, and is now providing you with answers to many of the questions that our customers frequently ask.

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Understanding ISO 14644-2:2015 Cleanroom Monitoring

ISO 14644 Part 21: Airborne particle sampling techniques.
Document Review

The Technical Committee (ISO/TC209) responsible for ISO 14644, the set of Standards governing cleanrooms and associated controlled environments, looked at the need for a new document to aid users in the application of airborne particle counters; especially considering the new revision to EU Annex 1 – Manufacture of Sterile Medicinal Products (2022).

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ISO/DTR 14644 -21:2023 Cleanrooms and associated controlled environments

Dust Dangers – Monitoring for unexpected events

Where there is dust, there is the problem. Operators often have to rely on a visible dust cloud to give them information that something is wrong. But what if there are no operators present?

The future of dust monitoring is automated, continuous and in real time

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The progress of technology in industrial bulk and powder handling has brought enormous improvement to operational efficiency and productivity. As production volumes have increased and industrial personnel staff has shrunk, threat management against dust explosions has become more challenging. Grain, sugar and other food industries are spending a lot of time, effort and money on the prevention of dust explosions.

Usually required by law, any organisation processing or handling combustible dust must perform an analysis of their dust hazards (DHA). The focus is usually on the typical points in the process where primary explosions tend to occur such as baghouses, silos, enclosed conveyors, cyclones etc. Focusing on possible secondary explosions is extremely important since historically secondary explosions are the most fatal. Material discharge from the process is common and usually suggests an interruption in the process. Continuous real time monitoring for such interruptions is often very beneficial as another line of defence.