By Derek Peterson, EO Sterilization Study Director
Ethylene oxide (EO) is a widely accepted form of sterilization for medical devices that are sensitive to radiation or heat.
Batch release sterilization is ideal for medical device manufactures whose devices are very specialized and expensive to produce thus limiting device quantities, or devices that are not in the final device or packaging configuration where conducting a full EO sterilization validation would be impractical. Batch release sterilization is an efficient way to obtain small quantities of devices that are deemed suitable for human use regardless of the design or production phase of the device. Batch release sterilization can produce as much as hundreds or thousands of sterile product for human use or as little as one single device.
-Scientist to highlight additional testing processes and strategic plans-
SALT LAKE CITY – April 11, 2012 – Nelson Labs (
www.nelsonlabs.com) Laboratory Manager Dan Floyd, RM(NRCM), will present to medical device manufacturers attending the
BIOMEDevice Boston Exposition and Conference, April 25-26 at the Boston Convention and Exhibition Center. Floyd was selected to present
Ethylene Oxide Sterilization of Small or Infrequent Lots: Batch Release Method at the
Innovation Briefs Theater, booth #1051, on Wednesday, April 25 at 12:30 p.m.
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.