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Validierbarkeit des F₀-Konzepts bei Dampfsterilisationsverfahren mit Sporen von Bacillus stearothermophilus

Validability of the F₀ Concept with Moistheat Sterilization Processes using Bacillus stearothermophilus Spores

The EG-GMP Guideline requires validation for all sterilisation processes; particular attention should be given when the adopted sterilisation method is not described in the current editon of the European Pharmacopoeia. Furthermore it ist required that for any sterilisation process its suitability for the product and its efficacy in achieving the desired sterilisation conditions in all parts of the load should be demonstrated by physical measurement and by biologicial indicators where appropriate. Biological indicators which are described in the pharmacopoeia for monitoring moist heat sterilisation processes are spores of Bacillus stearothermophilus with a certain spore population and resistance against the sterilising agent. When the F₀ concept of the pharmacopoeia comes into operation it should be demonstrated that the spores of the biological indicator mentioned above are inactivated in the same magnitude as they would be inactivated with the standard sterilisation cycle mentioned in the pharmacopoeia (121 ^oC/15 min). This demonstration can only be proven successfully, when, beside the certified spore poulation and the resistance (D-value at a temperature of 121 ^oC), the germ-specific z-value) in ^oC) is known. The latter value has to be determined experimentally in most cases, as it is not certified by the supplier.
With the known z-value equivalent lethalities according to the equation L = 10^(T-T₀)/z can be determined and the necessary sterilisation time for sterilisation temperatures lower than 121 ^oC can be adopted accordingly (for sterilisation temperatures higher than 121 ^oC the germ-specific z-value is approximately 10 ^oC so that the F₀ concept as described in the pharmacopoeia can be directly employed in these cases). When it can be demostrated experimentally that Bacillus stearothermophilus spores are inactivated in the same manner as they are inactivated with sterilistion temperatures of 121 ^oC (and shorter sterilisation times) the efficiency of the F₀ concept is demonstrated and the respective requirements of the EG-GMP Guideline are fulfilled. This fulfillment could be proven experimetally. Examples of this experimental proof are mentioned in this paper and thus it is demonstrated that the pharmacopoeial F₀ concept with temperatures lower than 121 ^oC can be successfully validated using spores of Bacillus stearothermophilus.

Key Words Bacillus stearothermophilus · Bioindikatoren · Dampfsterilisation, Validierung, F₀-Konzept