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Biological Indicators

D-Value determination

Z-Value determination

Confirmation of the survival-kill-time

Corroboration of Biological Indicators

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.

Determination of D-Value and z-Value in the BIER-Vessel or in Dry Heat

  • Determination of D-value for biological indicators by use of the FN-Method (Fraction-Negative method)
  • Determination of D-value for biological indicators by use of the Enumeration-Method
  • Determination of D-value for spore suspension in product or on surfaces
  • Determination of z-value (D-Value determination of a spore-prerparation with at least three different temperatures)
  • Examination of Survial / Kill-times

Additional Services

  • Additionally, we offer a documentation of the process-data in compliance with CFR-Part 11. The data is being recorded with our Kaye Validator.
  • We can as well provide you with an independently certificated spore suspension for the corroboration of your D-Value.
  • We may also prepare and certificate individual biological indicators for our clients.

Do you need help with complex microbiological questions? Talk to us!

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