The role of data quality systems in pharmaceutical organizations has grown faster than any other function during the last 15 years. During this period, a small group dedicated to traditional Compliance grew and expanded to include Quality Experts in areas such as validation, product release, operations, sterility assurance, and other…
Welcome to our USP 1116 questions and answers blog, where Particle Measuring Systems answers commonly asked questions pertaining to the USP 1116 guidance. What guidance is there for non-sterile facilities in regards to CRR (aseptic processing)? It is important to note that <1116> is a “general information” chapter, and as such,…
Why the USP 1788 update? New flow imaging technologies and therapeutic protein solutions widened the scope of USP 1788. Three primary technologies are discussed in each of the sub-parts of the guidance document: Light Obscuration (LO) is still the preferred first-pass method for the USP Normative chapters. If a solution is…
Background on Vaporized Hydrogen Peroxide (VHP) Vaporized Hydrogen Peroxide (VHP) is a strong oxidizing agent used to sterilize enclosed filling isolators. It’s been around for years, its applications growing in number. Robust sensors capable of withstanding these environments are needed to fully match the increasing use of VHP. Portable particle counters can be…
