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 VDmax values.