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Good Manufacturing Practice (GMP) refers to the systems and controls used to ensure products are consistently manufactured and controlled for their intended…

USP published a major revision to General Chapter <797>, Pharmaceutical Compounding –Sterile Preparations, on November 1, 2022. The revised chapter…

Cleanrooms & Their Importance Cleanrooms are controlled environments designed to limit airborne contamination and support a specific process. The term “…

What Are Cleanroom Design Standards? Cleanroom design standards translate process, product, personnel, and contamination-control needs into requirements…

An ISO Class 8 cleanroom is classified under ISO 14644-1 based on the concentration of airborne particles. At 0.5 micrometers (µm) and larger, the maximum…

Cleanrooms play a critical role in pharmaceutical manufacturing by controlling airborne particulate levels and supporting contamination control. Cleanrooms may…

What It Means to Keep a Lab Science-Ready A science-ready laboratory has the equipment, facility systems, documentation, supplies and trained personnel needed…

Cleanrooms provide controlled environments for products and processes that are sensitive to airborne contamination. They are used across pharmaceuticals,…

ISO cleanroom classifications provide a standardized way to define and verify airborne particle cleanliness. Understanding the applicable class helps facility…

Computer system validation (CSV) provides documented evidence that a computerized system is fit for its intended use and performs consistently in a regulated…