Biologische Indikatoren bei Sterilisationsverfahren
Eignung biologischer Indikatoren zur Verifizierung des Erfolgs von Sterilisationsverfahren
Originale
Key words Bioindikatoren | Sterilisationserfolg | Sterilisationsmethoden
Abstract
Biological Indicators in Sterilisation / Suitability of biological indicators for the monitoring of sterilization success
Biological indicators may be used to monitor sterilization success of moist and/or dry heat sterilization and sterilization by irradiation, and must be used to validate and monitor sterilization with gas. The bioindicators will be safely inactivated by the sterilization methods being mentioned e. g. in the European Pharmacopoeia; nevertheless, there is a tiny chance that the bioindicators used show surviving spores after being exposed to the respective sterilizing agent. Normally it is expected that > 1 biological indicator is to be used for validation and routine monitoring of sterilization methods.
In a survey among German pharmaceutical companies that have e. g. sterile products in their portfolio, it was tried to find out how the “bioindicator problem” is handled. In case of the sterilization methods mentioned in e. g. the European Pharmacopoeia the “daily business” was compared with the requirements of these normative guidances (Pharmacopoeia and/or EU GMP Guideline). The result of this survey showed great variability in the use of biological indicators: From only one bioindicator being used in routine sterilization monitoring up to > 100 in case of validation.
Korrespondenz:
Dr. Michael Pfeiffer, Global Quality Services, Boehringer Ingelheim Pharma GmbH & Co. KG (HPZ 3337-02-07), Binger Straße 173, 55216 Ingelheim a. Rh., Germany; e-mail: michael.pfeiffer@boehringer-ingelheim.com
Zusammenfassung
Biologische Indikatoren können eingesetzt werden, um den Erfolg von Sterilisationsmethoden und -verfahren wie gespannter und/oder gesättigter Dampf (Autoklav), Trockenhitze und Strahlen, zu belegen, und weiterhin werden sie hauptsächlich eingesetzt zur Validierung von Gassterilisationsverfahren. Die Bioindikatoren zur Überwachung des jeweiligen
