کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
1884005 | 1043318 | 2012 | 4 صفحه PDF | دانلود رایگان |
The VDmax approach for substantiation of 25 kGy has been in use for more than 10 years. VDmax methods are included in ISO 11137-2:2006 and AAMI TIR33:2005. 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 VDmax 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 VDmax 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 VDmax were derived and tabulated for substantiation of a 16.1 kGy sterilization dose.Values of VDmax have been derived and tabulated for the substantiation of sterilization doses linked to a sterility assurance level (SAL) of 10−3. To offer a potential alternative to aseptic processing, the notion of using an “aseptic processing equivalent dose”, 10−4 SAL, has been investigated along with the use of alternate model populations for calculation of VDmax values.
► Method VDmax is a safe and reliable method for substantiation of a sterilization dose.
► Values of VDmax have been calculated for a 12.5 kGy sterilization dose.
► Product-specific VDmax values can be calculated for special situations, e.g. VDmax16.1.
► Values of VDmax for SAL values other than 10−6 have been calculated and tabulated.
► VDmax values can be calculated based on alternate model microbial populations.
Journal: Radiation Physics and Chemistry - Volume 81, Issue 8, August 2012, Pages 1232–1235