North American Sterilization & Packaging Company
17 Park Drive, Franklin, New Jersey 07416 USA
Phone:1.973.209.4388    1.800.392.6310       Fax:1.973.209.6374        Email: info@naspco.com

(continued from page 2, Headspace Gases)

Speeding EtO-Sterilized Products to Market with Parametric Release (continued)

Load Configuration

Another obstacle to parametric release is the difficulty of accurately predicting load configuration. Validations are typically designed for load configurations that represent the most difficult products to sterilize. Rather than validate every single product manufactured (which, in the case of custom kits, for example, could require years and enormous expense), products are usually grouped according to similarities in physical construction, geometries, and bioburden test results.⁶ Those that are the most difficult to sterilize, that present the greatest physical and microbial challenges to the process, are used to build validation loads.

But there are some important variables that can remain unaccounted for in this procedure. For example, sterilization engineers often neglect to compare each component's ability to absorb water vapor and sterilant gas. If a load contains a large portion of cotton fiber material, such as contained in gowns, towels, and gauze, a sterility failure may be caused by water vapor and EtO depletion.⁷ The use of BIs would reveal such a failure, but in parametric release, water vapor and EtO must be monitored throughout the entire cycle, and the absorbency of the load must be taken into account.

More precisely metering the amount of sterilant needed by taking into account load configuration will also save expense and create safer products. By using only the required amount of EtO, sterilizers can reduce residuals on the product, aeration time, and patient and employee exposure. This optimized process will also reduce demand on the environmental control systems at the sterilization site by lowering primary and secondary emissions.⁸

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