Category: Facility Monitoring
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.
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.