WASHINGTON, DC—January 19, 2012—On December 15, 2011, nine Nelson Laboratories, Inc., Salt Lake City, UT, microbiologists were certified as Registrants of the National Registry of Certified Microbiologists (NRCM). To earn the NRCM credential, they first met rigorous educational and experiential eligibility requirements and then passed a comprehensive written examination.
By Daniel Curtin, Study Director in Chemistry at Nelson Labs
Nelson Laboratories has added a microscopic FTIR to its Fourier Transform Infrared Spectroscopy (FTIR) capabilities, for increased sensitivity and accuracy when conducting FTIR testing. The FTIR measures molecular vibrations that are unique to different chemical structures. This allows the FTIR to produce unique spectra which can be used to identify organic compounds such as oils, polymers, and pharmaceuticals by comparing the unknown spectrum to a database of known standards.
By Jeff Peterson, B.S. Study Director, Packaging
Container Closure Integrity testing can be performed using physical tests for stability programs rather than sterility testing according to the draft FDA document “Guidance for Industry- Container and Closure System Integrity Testing In Lieu of Sterility as a component of the Stability Protocol for Sterile Products”. Due to the limitations of sterility tests (which only detect a viable organism if promoted in the correct media) alternative test methods are being considered as more appropriate. One of the most popular and simple packaging tests to help accomplish this is the Dye Immersion or Container Closure Integrity test.
By Alpa Patel, Department Scientist, Hospital Reprocessing, BS, RM(NRCM)
As technology advances, so does the complexity of the medical devices. The industry of reusable medical devices is facing increased scrutiny to previously accepted validation methods. Cleaning, disinfection and sterilization methods are being analyzed in greater detail by the FDA. The FDA is recommending increased testing procedures that more closely simulate actual and clinical use.
By Alpa Patel, Department Scientist, Hospital Reprocessing, BS, RM(NRCM)
For many years Nelson Laboratories has been providing tissue process validation for manufacturers, tissue banks and organ procurement organizations (OPOs). Nelson Labs provides a full gamut of tissue testing services to the tissue industry.
by Sara Toole, Microbiology Department Manager, B.S. RM(NRCM) CQA (ASQ)
Tissue banks provide a great service for those in need. But, just like pharmaceuticals and medical devices, donated tissue needs to be rendered safe before it can be used on patients. The American Association of Tissue Banks (AATB) and the Food and Drug Administration (FDA) set the standards for procurement, processing and distribution of tissue. For skin donations, the tissue must meet criteria as determined by the AATB to be considered acceptable.