Maintaining a sterile and safe environment in pharmaceutical environments is paramount. To ensure the highest standards of quality and safety, USP <797> has set forth new guidelines becoming effective November 3rd, 2023. These new regulations require monthly surface sampling frequency for potential microbes and more stringent action levels for microbial contamination, raising awareness about the importance of proactive contamination prevention in sterile compounding and “clean room” facilities.
Pharmacies are not immune to microbial contamination. It poses a significant threat to pharmaceutical environments. Viruses can mutate, rendering traditional disinfection methods less effective. Commonly found microorganisms in pharmaceutical environments include Micrococcus, Coagulase-Negative Staphylococci, Coryneform Bacilli and Bacillus,  as well as Aspergillus, and Pseudomonas.
The consequences of microbial contamination can affect product quality, patient safety, and the well-being of workers. USP <797> serves as a critical tool to combat this issue. With monthly surface testing, it’s statistically more likely that facilities will encounter positive samples. While this may seem concerning, it highlights the importance of regular monitoring and the need for effective disinfection methods that can keep up with the challenge.
To address the new USP guidelines, Surfacide has developed SURFrx, an evidence-based disinfection program for sterile compounding environments that serves as an adjunct to environmental cleaning and disinfection efforts. This program leverages the power of industry-leading UV-C technology to achieve 6 log reduction in vegetative bacteria, lipid viruses and various fungi to ensure thorough and effective surface/air disinfection is being achieved.
In light of the USP <797> requirements and the increasing threat of microbial contamination, it’s crucial to take proactive steps to protect your product, patients, and workers.
Contact us today to learn how to get SURFrx in your facility.
Reference: Dr. Deanna Kiska, CEO -U.S. Micro Solutions, Inc.