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Applying Appropriate Limits in Cleanroom Monitoring
Protect the cleanliness of your environment by utilizing limits in cleanroom monitoring, including standards like ISO 14644-1:2015 and the EU GMP Annex.
Protect the cleanliness of your environment by utilizing limits in cleanroom monitoring, including standards like ISO 14644-1:2015 and the EU GMP Annex.
What Cleanroom Data Analytics in Pharmaceutical Manufacturing Should be Considered When Setting up Environmental Monitoring? Pharmaceutical Manufacturing Data Analytics and Managment is one of the important steps for effective contamination control In a typical pharmaceutical manufacturing plant, there are several important tasks to ensure the product can be handled without…
This blog explores the pivotal role of real-time aerosol particle monitoring in semiconductor manufacturing, specifically focusing on the innovative solution provided by Particle Measuring Systems’
Annex 1 is a foundational document for modern cleanroom design. Introduced in the 1990s and updated in 2023, it specifies the requisite concentrations of environmental airborne particles for sterile medicinal product manufacturing. The document also references ISO 14644-1 for classification. There are numerous facets to the document. So many, in fact, that its limitation of sample tubing to a single meter may seem like a minor detail. But it has profound implications for the accuracy and reliability of particle measuring systems.