by Bryan Brezoff, ID’s Section Leader, BS, SM RM(NRCM) & Jacob Lee, B&F Study Director, BS, RM(NRCM)
Most people are aware of the need to meet the USP<71> standard test of sterility, but they are quite often less aware of the included B&F requirement—B&F meaning Bacteriostasis and Fungistasis (also referred to as method suitability or sterility validation). Manufacturers need to be aware of this test to ensure their products meet the sterility validation requirements.
By Sara L. Toole, Microbiology Department Manager, B.S., RM(NRCM), CQA(ASQ) and Jonathan Swenson, Microbiology Study Director II, B.S., RM(NRCM)
Suitability testing is an important assessment tool used to validate the ability to recover microorganisms from non-sterile test articles when performing USP <61> plate count microbial enumeration testing.
By Bryan Brezoff, ID Section Leader, BS, SM(NRCM)
By Jacob Lee, Environmental Monitoring Study Director, BS
Frequently Nelson Labs receives questions from clients in regard to environmental monitoring (EM). It is a necessary tool to help us know when problems arise due to environmental contamination. EM testing, microbiological surveillance, or incubation and enumeration are important to ensure environments remain within a particular state of control throughout the product manufacturing process. Monitoring of the surface and air quality will provide a way to measure the quality control systems put in place to achieve a controlled environment (HEPA, air exchange, disinfectant program, etc.). The frequency of EM testing should be based upon the amount of control you are looking for and often relates to the type of controlled environment you are monitoring. Since EM testing provides a retrospective look at your environment it makes sense that if you require more control then you should test more frequently. A higher frequency of sampling allows you to take action sooner if you do happen to have an environment that is out of specification.
By Alexa Tatarian, B.S., Project Coordinator
According to Good Manufacturing Practice (GMP) regulations and increased regulatory demand, testing in regard to the cleanliness of a medical device after the manufacturing and cleaning process needs to be completed and documented. Residual oils, lubricants, polishing compounds, detergents, and other contaminants from the manufacturing and cleaning process can affect the function and safety of medical devices.