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…
Batch In Situ Particle Monitoring Batch In Situ Particle Monitoring offers a rapid and cost-effective requalification of wet process tools following chemical changes or filter replacement. In these applications, a particle counter is mounted on a cart and moved from one sample location to another. This mobile sampling approach maximizes…
