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.
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.