Medical Device Literature By QSI Literature by Quality Solutions and associates. (Please feel free to propose new ideas for publications) Sordellini, PJ, "Industrial Ethylene..., 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...

biocompatibility tests, even if material suppliers claim their materials are biocompatible. Paul Sordellini, a consultant with Quality Solutions, Inc. (Annandale, NJ), and a member... that the raw materials are medical grade and biocompatible. Do we need to perform any additional biocompatibility studies on the finished device? Sordellini: During the design phase of device...

--Validation and Routine Control of Ethylene Oxide Sterilization, EN 550:1994, Section B.5.2, Parametric Release, Brussels, European Committee for Standardization, 1994. 4. Sordellini PJ...

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...

Investigating and Preventing... Investigating and Preventing BI Sterility Failures Paul J. Sordellini and Marjorie Lang Because microbiological destruction is logarithmic..., London, EUCOMED, pp 13 23, 1989. Paul J. Sordellini is an industry consultant with Quality Solutions, Inc. (Annandale, NJ), and Marjorie Lang is an industry consultant with Lang Consulting Services (Minnetonka, MN). * ...