By Courtney Lang, Study Director, EO Department, BS, RM(NRCM)
Ethylene oxide (EO) validation is conducted as part of a 510(k) or PMA submission. It validates the EO sterilization process as a whole and ensures that the process produces product that meets requirements for a sterility claim. The validation is specific to the product, loading configuration, cycle parameters and sterilization chamber.
By April Wanstrom, IDs Department Scientist, BS, RM(NRCM) SM(NRCM) CQA ASQ
According to AAMI/ISO 11137, medical device manufacturers need to know the “number and types of microorganisms” found on their devices before sterilization. The bioburden test provides the number of microorganisms, and the Gram stain test can determine the types.
By Andy D’Ewart, Microbial Identifications Study Director
With dozens of tests required to get your product to market, it might be tempting to leave out Gram stain testing. At Nelson Labs, we recommend adding a Gram stain to your genetic identification testing to save you time and money in the long run while providing a more comprehensive identification. A Gram stain with a colony morphology description will reinforce the identification and can eliminate some of the most common failures in genetic testing.
By Kimberlee Dickman, Study Director III, Pharmaceuticals, BS, RM(NRCM), ASQ(CQPA)
Container Closure Integrity Testing is performed to evaluate the adequacy of a closure in maintaining a sterile barrier. Of primary concern is whether the container can provide an effective barrier against ingress of microorganisms and other substances that may compromise or contaminate the product.
By Ryan D. Lunceford, Study Director, Particulate Matter Testing, B.S., ASQ
Particulate Matter Testing is required on all pharmaceutical products that come in contact with human blood or tissue. The standard is USP 788 for blood and tissue and USP 789 for contact with the human eye.