Blog Archive

Good Manufacturing Practice (GMP) refers to the systems and controls used to ensure products are consistently manufactured and controlled for their intended use. In the United States, the Food and…

USP published a major revision to General Chapter <797>, Pharmaceutical Compounding –Sterile Preparations, on November 1, 2022. The revised chapter became official on November 1, 2023, and…

Cleanrooms & Their Importance Cleanrooms are controlled environments designed to limit airborne contamination and support a specific process. The term “type of cleanroom” can describe several…

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

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 concentration is 3,520,000 particles per…

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

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

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

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

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