Substantiation of 25 kGy as a sterilization dose: a rational approach to establishing verification dose
In: Radiation Physics and Chemistry, Jg. 54 (1999), S. 55-64
Online
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Zugriff:
The international and European standards for the validation and routine control of sterilization using ionizing radiation require that the effectiveness of a sterilization dose of 25 kGy be demonstrated (substantiated). Use of existing documented methods for substantiation has led to the observation of unexpected failures in the verification part of the procedures. Examination of the radiation response of microbial populations comprising the reference Standard Distribution of Resistances has revealed a potential reason for these unexpected failures and led to the development of a new approach for choosing the dose to be used in the verification experiment for substantiation of 25 kGy. This approach, which involves the calculation of a maximal acceptable verification dose (VDmax) for a given bioburden and verification sample size, provides a direct link between the outcome of the verification dose experiment and the attainment of an SAL of 10−6 at a 25 kGy sterilization dose. Use of a maximal verification dose would minimise the probability of unexpected and unwarranted failure in the verification procedure.
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Substantiation of 25 kGy as a sterilization dose: a rational approach to establishing verification dose
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Autor/in / Beteiligte Person: | Kowalski, J.B. ; Tallentire, A. |
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Zeitschrift: | Radiation Physics and Chemistry, Jg. 54 (1999), S. 55-64 |
Veröffentlichung: | Elsevier BV, 1999 |
Medientyp: | unknown |
ISSN: | 0969-806X (print) |
DOI: | 10.1016/s0969-806x(98)00206-0 |
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