
FAQ’s: Class D Particle Monitoring Requirements
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.”
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.
What Is GPT? The Growth Promotion Test (GPT) determines the appropriateness of the culture media to be used in environmental monitoring sampling. The medium is challenged with a small number of microorganisms to assure the nutritive properties, functionality and media quality are adequate for the detection and enumeration of microbial…
In this video interview, the team from AUSTAR UK discuss why and how they worked with Particle Measuring Systems’ (PMS) exclusive UK distributor, EMS Particle Solutions, to provide an AUSTAR sterility test isolator customer with a complete viable and non viable particle counting solution using PMS instrumentation and equipment.