New applications of the VD_max approach to substantiation of preselected sterilization doses

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• 作者：J.B. Kowalski ; ^{jkowalski@sterigenics.com}
• 关键词：Radiation sterilization ; Dose substantiation ; Method VDmax
• 刊名：Radiation Physics and Chemistry
• 出版年：2012
• 期刊代码：68_0969806x
• 类别：ph
• 出版时间：August, 2012
• 卷：81
• 期：8
• 页码：1232-1235
• 文件大小：174 K

摘要

The VD_max approach for substantiation of 25 kGy has been in use for more than 10 years. VD_max methods are included in ISO 11137-2:2006 and . ISO Technical Specification, 13004, is under development that will include sterilization doses from 15 to 35 kGy.

For substantiation of a sterilization dose for very low bioburden products, less than or equal to 0.3, values of VD_max have now been derived and tabulated for a sterilization dose of 12.5 kGy.

Products have been encountered that have both low bioburden and a relatively low maximum dose. In several situations, existing tabulated VD_max values could not be effectively used; in one such situation, the average bioburden was too high to substantiate a 15 kGy sterilization dose and the use of a 17.5 kGy sterilization dose was not practicable due to the likelihood of exceeding the product's maximum acceptable dose. For this product, values of VD_max were derived and tabulated for substantiation of a 16.1 kGy sterilization dose.

Values of VD_max have been derived and tabulated for the substantiation of sterilization doses linked to a sterility assurance level (SAL) of 10^鈭?. To offer a potential alternative to aseptic processing, the notion of using an 鈥渁septic processing equivalent dose鈥? 10^鈭? SAL, has been investigated along with the use of alternate model populations for calculation of VD_max values.