Biological Indicators 

 

 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

 

 

Biological Indicators BIER-Vessel 

 

 

 

For further information on Biological Indicators and price information of D-Value Determination simply get in Contact with us.

 

You can also download our full service catalogue to get information on any additional services.

 

 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

 

 

 

 

 CFR-Part 11

 

  • Additionally, we offer a documentation of the process-data in compliance with CFR-Part 11. The data is being recorded with our Kaye Validator

 

 

 

 Additional Services related to D-Value determinations

 

  • 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