USP <1116> and its Implications for Measuring Microbial Recovery Rates


Particle Measuring Systems (PMS) know the most cited observations with regulatory bodies is because of aseptic processing deficiencies. We also know it’s hard to keep up on the continuous changes to standards and regulations made to support the quality and safety of finished drug products.

That’s why we’ve developed a white paper to help you maintain statistically significant data even with the recent updates made to the United States Pharmacopeia (USP) chapter <1116> on Microbiological Control and Monitoring of Aseptic Processing Environments.

This white paper will give you:

  • Easier and shorter reading on the new Contamination Recovery Rates (CRR) updates
  • Recommendations when adopting CRR
  • Knowledge on how to prevent microbial contamination in your product, process and environment
  • Ways to manage your Alert or Action Levels with contamination events

Originally published in the Parenteral Drug Association PDA Letter Volume LI, Issue 6 June 2015 edition, we are pleased to offer this paper to you to download.

A note from the author:

“The release of the new USP <1116> highlights the new paradigm of Contamination Recover Rates (CRR) where old enumerative methods prevailed. Partnering with PDA by publishing in the PDA Letter magazine was a way for us to give industries we service a better understanding of CRR. We hope they can use this knowledge and implement it into their everyday processes and applications.”
---- Dr. Claudio Denoya, Senior Applications Scientist