Data Management for Environmental Monitoring in a Pharmaceutical Manufacturing Facility

What Data Management Factors Should be Considered When Setting up Environmental Monitoring in a Pharmaceutical Manufacturing Facility? Pharmaceutical Manufacturing Data 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…

Particle Measuring Systems in Cleanroom Monitoring

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.