(continued from page 1) AIR REMOVAL Deeper vacuums can complete air removal with fewer sequences. When dealing with a vacuum-resistant product, one vacuum from atmospheric (14.7 psia) to 2.0 psia, followed by a nitrogen backfill to 14.7 psia, will quickly reduce the %volair to 13.6% (Table I). Produ...

(continued from Page 4, Sampling) Speeding EtO-Sterilized Products to Market with Parametric Release (continued) Gas Analysis: Chromatography After determining how to draw the gas samples, sterilization engineers must also decide on a gas analysis method. The two most common ways to analyze in-chamb...

(Continued from Page 6, IR Spectroscopy) Speeding EtO-Sterilized Products to Market with Parametric Release (continued) IR Spectroscopy for Gas Diffusion EtO sterilization has traditionally taken place in stainless-steel, vacuum-pressure vessels with extensive ancillary equipment. However, for more ...

Biocompatibility Testing Is Needed Despite Material Supplier Claims When selecting materials, medical device manufacturers must perform biocompatibility tests, even if material suppliers claim their materials are biocompatible. Paul Sordellini, a consultant with Quality Solutions, Inc. (Annandale, N...

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