Pharmacy Environmental Monitoring: Performing Viable Sampling

By Adam West, Environmental Monitoring and Training Specialist at CriticalPoint

I’ve been a part of the design, construction, and testing of cleanrooms for 16 years, but my greatest interest is environmental monitoring (EM). Mastering EM sampling is no small feat. And as an environmental monitoring specialist, I’ve known the importance of training field technicians even before it was a thing! Let’s dive into why building USP 797 competency for sample collection in cleanroom environments matters.

Do Your Vendors Perform Environmental Monitoring?

But really, the question should be more specific. Do your vendors have SOPs, proper training, and competency testing in place to perform your viable environmental monitoring sampling? 

Did you know that the term “personnel” is mentioned 146 times in USP 797? And it’s used most often to describe the specific function that “personnel” may have. You’ll read examples like “compounding personnel,” “authorized personnel,” “in-process personnel.”  

However, one sentence regarding air and surface monitoring immediately caught my attention. USP 797 states, “It is important that personnel are trained and competent in air and surface sampling procedures to ensure accurate and reproducible sampling.” Which personnel exactly? There is no specific context to the term personnel used in this sentence other than stating it is important that personnel who perform air and surface sampling are trained and competent to ensure accurate and reproducible sampling.  

I don’t mean to sound like a provocateur, and stay with me on this; we are responsible for ensuring anyone entering the sterile compounding environments performs the proper steps to enter and garb, right? We are also responsible for the safety of our visitors in HD environments.  Read more >