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.
In our previous blog in this series, we learned about the many forces that can act on a particle when it travels through tubing. Now, let’s take a look at how we can mitigate these forces on our particle data. Isokinetic Particle Sampling The first way to ensure reliable, accurate data…
In our previous blog we learned about ways to mitigate particle losses in transport tubing from the sampling inlet near a critical point in a process, to the particle counter. Here, we’ll learn about the ways in which some losses are there to stay.