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…
Question: “What is the need of taking a non-viable particle count after a power outage for an hour. Our Class C area is stabilizing after 30 minutes of a power cut?” There are several reasons for deploying your Non-Viable Environmental Monitoring Program following a power outage, but primarily it is to…
Question: “Can you speak to the requirements for monitoring Class D clean areas for viable and nonviable particulate. The regulations don’t make it black and white.”
Welcome to our EU GMP Annex 1 questions and answers blog, where experts answers commonly asked questions about the latest changes to regulation.