NewsAirflow Visualization best particle counter ISO cleanroom standards

ISO Cleanroom Standards

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.

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5 Key Principles of Cleanroom Particle Counting

In this blog post, we take a look at five key principles of cleanroom particle counting, exploring the significance of each principle and how it contributes to maintaining the safety and quality of products manufactured in such environments.

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Contaminated Eye Drops and Effective Contamination Control

Once again, the specter of contaminated eye drops reaching patients has made headlines, according to the FDA, federal investigators found harmful bacteria and “insanitary conditions” at a factory where several eye drop products are made. The agency said it advised the manufacturer to recall the products.

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Single-Use Microbial Impactor for Active Air Sampling

Here we will briefly explore the history, applications, and recent advancements in single-use impactors for active air microbial sampling, with a focus on a groundbreaking single-use alternative.

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