Technical Papers and Articles

NASP employees and colleagues have authored several technical papers and articles which are now archived at our website.  You can read these online, print them or download them in in a MS Word .doc file format to view at your leisure.

If you have any questions about the information presented in these articles, please use the Inquiries button above to fill-out our online inquiry form or send us an email at info@naspco.com.

Following is a brief synopsis of the papers and articles archived at our website.

"Industrial Ethylene Oxide Sterilization of Medical Devices -What Hospitals Need to Know About Re-Sterilization of Single Use Devices," Annual EFHSS and MSÜD Conference 2004, Altin Yunus Hotel, Cesme, Izmir, Turkey 5-7 May 2004.

Optimizing EtO Sterilization, Paul J. Sordellini (MDDI, Aug 2001, p. 70). Category: Sterilization.

EtO Sterilization: Microbiological Aspects of Process Validation
Deliberate decision making during the structuring of microbial challenges, product loads, and biological indicators can provide a validation process for EtO sterilization that ensures accuracy, the absence of microbes, and a smooth testing procedure.

EtO Sterilization: Principles of Process Design
By following a structured method, process engineers can design and validate safe and efficacious EtO sterilization cycles.

Speeding EtO-Sterilized Products to Market with Parametric Release
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.

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.

Evaluating Sterilizer Performance as Part of Process Equivalency Determination
Medical device manufacturers that use ethylene oxide (EtO) to sterilize their products, either in-house or at a contract sterilizer, often validate the cycle in one particular vessel and later find it no longer satisfies their requirements. A validated vessel becomes outgrown when the number of devices manufactured per week exceeds its volumetric sterilization capacity.

Investigating and Preventing BI Sterility Failures
Because microbiological destruction is logarithmic and therefore can only be expressed in terms of the probability of a survivor, the term sterile device does not actually refer to a device that is totally free of viable organisms, but rather to one whose probability of containing a viable organism is so small that it is considered acceptable. Hence the use of the sterility assurance level (SAL) to describe the degree of sterility of a device.

Parametric Release Comes To ETO Sterilization
After decades of anguishing over long aeration times and interminable incubation periods, manufacturers of medical devices sterilized with ethylene oxide (EtO) may finally be getting something of a break. Thanks to the efforts of industry experts in the United States and abroad, significant attention is now being paid to the possible use of parametric release for EtO-sterilized devices.

You can click on the title of the paper/article above or use one of the links below to read them