By Jonathan Swenson, Microbiology Department Manager, B.S., RM(NRCM)
Managing the potential microbial risks when manufacturing non-sterile products can be a complex task. Risk-based assessments are used to help determine the manufacturing areas that may contribute to product contamination by objectionable microorganisms. The contamination areas are important to identify because of the risk to the final product. The risk analysis is used to determine the product acceptance criteria which may include quantitative limits, qualitative requirements and/or other specific criteria that must be achieved during a determined sampling and testing plan.
By Quinton Inglet, LAL Department Manager at Nelson Laboratories
Recently, there have been many changes to the Bacterial Endotoxin Test (BET) [LAL Test] requirements. It’s important for medical device manufacturers to know that the Food and Drug Administration (FDA) is looking at many different aspects of LAL testing. The focus seems to have moved beyond the systemic issues caused by Bacterial Endotoxins and now affects multiple areas of the manufacturing process and final product. The support we are asked to provide as a contract test lab has exposed us to the increase in questions asked regarding sampling plans, rationale for reduced samplings, an expectation of more detailed justifications and product specifications.
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.