Conclusion (continued from Page 8, MW Spectroscopy) Speeding EtO-Sterilized Products to Market with Parametric Release (continued) Conclusion There are still many challenges... to face in EtO sterilization. For example, it is difficult to determine the amount of sterilant to use, and so companies must estimate based on worst-case predictions. Because... and water vapor will be needed in a given cycle. Therefore, EtO cycles typically employ more sterilant and water vapor than is actually necessary. In this way, fluctuations...

IR Spectroscopy for Gas... (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 than 25 years there has been... spectroscopy to measure the gases. In gas diffusion, liquid EtO is vaporized directly into a low-density polyethylene (LDPE) bag that contains several finished devices, each in individual...

Speeding EtO-Sterilized... Speeding EtO-Sterilized Products to Market with Parametric Release Paul J. Sordellini The difficulty of measuring EtO and water vapor during processing... has been a major obstacle to adoption of parametric release by EtO sterilizers, but the latest gas analysis techniques are making in-process monitoring and control possible... Analysis: MW Spectroscopy Conclusion References Introduction According to industry experts, ethylene oxide (EtO) is used for more than half of all medical devices sterilized. Despite...

EtO Sterilization: Principles... EtO Sterilization: Principles of Process Design By following a structured method, process engineers can design and validate safe and efficacious... EtO sterilization cycles. Paul J. Sordellini, Susan Edel Satter, and Vincent A. Caputo Among the sterilization technologies currently available to the medical device industry, 100...% ethylene oxide (EtO) gas remains one of the most popular. Validated EtO processes can be run in sterilizers ranging from BIER vessels of a few cubic feet to industrial-sized...

, Izmir, Turkey 5-7 May 2004.Sordellini, PJ., Bonanni, FR., Fontana, GF., "Optimizing EtO Sterilization," Medical Device & Diagnostic Industry, 23(8): Aug. 2001. Satter, SE., Sordellini... PJ., "EtO Sterilization: Microbiological Aspects of Process Validation," Medical Device & Diagnostic Industry, 21(4): 85-99, Apr. 1999. Sordellini, PJ., Satter, SE., Caputo, VA...., "EtO Sterilization: Principles of Process Design," Medical Device & Diagnostic Industry, 20(12): 47-59, Dec. 1998. Sordellini, PJ., Caputo, VA., "EO Sterilization: Validation...