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Confirmation of the survival-kill-time
following ISO 11138 or USP
Biological Indicators are being used to ensure the effectiveness of sterilization processes. The D-Value (Decimal Reduction Time) is an individual value of a Biological Indicator that determines the time interval it takes to reduce the amount of microorganisms by one log (by one decimal power). These Values may vary for each lot of Biological Indicators through the slightest deviations in the manufacturing process or through influences of the product that they are being used with.
Our company has specialized on the determination of the D-Value of Biological Indicators. Our expertise as an independent laboratory in all matters of Biological Indicators has been established over the past ten years, in which we performed numerous D-Value determinations. Determinations of D-Values at our company can be performed either in the BIER-Vessel (steam sterilization) or in dry heat. Our equipment matches the requirements of AAMI and ISO 11138-3.