Do you require certified BIs for the validation of sterilization or decontamination processes?
The quality of the BIs is essential for the efficient development and validation of the sterilization processes that precede aseptic filling (EU GMP, Vol. 4, Annex 1).
Valicare offers you pre-tested BIs with quality certificates or tests and certifies your own BIs.
The use of insufficiently characterized BIs complicates or even prevents successful validation of decontamination processes isolators. This costs money and binds human resources.
Want to know how to avoid this? Just give us a call!
Our experts have been successfully developing and validating decontamination and sterilization processes in isolator systems and autoclaves for over 20 years. They are familiar with the technical, regulatory, and process-related challenges.
Benefit from their expertise and experience to achieve an efficient validation of your decontamination process.
Both, sterilization processes in autoclaves and decontamination processes with vaporous hydrogen peroxide (H2O2) in isolators normally use spores of Geobacillus stearothermophilus.
These spores are an appropriate model system due to their high resistance and growth properties at high temperatures (55-60°C). This allows validation under stringent conditions and specific test evaluation.
For the characterization and quality control of BIs, Valicare offers a comprehensive initial qualification, according to DIN EN ISO 11138-7:2019-11.
An overview of our services:
- D-value determination: We system-specifically determine the decimal reduction value (D-value), which indicates how long organism must be exposed to a specific sterilization process to achieve 90 % of microorganisms to be killed.
- Spore count: Microbiological quantification of the spore counts per biological indicator. A precise determination is the basis for the D-value calculation.
- Spore identification: We identify the spore strain on the BI according to norms and with a validated test method to ensure that Geobacillus stearothermophilus is really used.
- Documentation and evaluation: Results are documented in a GMP-compliant format, suitable for providing evidence to authorities or auditors.
- Own biological indicators: Upon request, we offer biological indicators with test certificates – customized to your application. This option is particularly aimed at customers who want to plan and implement their validation strategy from a single source.