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Testing of Biological Indicators (BIs)
Testing of Biological Indicators (BIs)

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.

Good reasons to work with us:

Over 20 years of experience with decontamination and sterilization processes
Over 20 years of experience with decontamination and sterilization processes
Qualified testing laboratory (DIN EN ISO 14644) with a pharmaceutical-grade isolator
Qualified testing laboratory (DIN EN ISO 14644) with a pharmaceutical-grade isolator
Human resources with regulatory expertise offer intelligent solutions
Human resources with regulatory expertise offer intelligent solutions
GMP-compliant documentation of test results
GMP-compliant documentation of test results

The D-value determines the resistance characteristic of a BI batch.

The system D-value is performed in a standardized system and determined according to the Limited Holcomb-Spearman-Karber method (LHSKP). It is an indicator of the resistance of a specific BI batch.

Only when the D-values are determined in the same system, different batches can be compared for their resistance. This also provides insights into the killing behavior of a batch and reveals hyper resistant indicators (“rogue BIs,” “late survivors,” or “anomalous BIs”) that may occur. A batch containing such indicators should not be used for validation purposes, as this could lead to false positive results.

The system D-value is determined in accordance with DIN EN ISO 11138-7:2019-11: Sterilization of healthcare products – Biological indicators – Part 7: Guidelines for the selection, use, and interpretation of results (ISO 11138-7:2019); German version EN ISO 11138-7:2019 from 30 sample groups, each with 10 or 20 individual samples, and a sampling interval of one minute each.

Valicare conducts practical D-value determinations under realistic process conditions in a pharmaceutical-scale isolator – upon request, also for your specific systems.
All results are documented in a traceable manner and processed in accordance with GMP.

We precisely quantify the count of spores as part of the quality control.

Decontamination processes are supposed to provide a 6-log reduction of microorganisms. To deliver proof, a BI must be occupied with at least 106 spores.

The bacterial count is determined in accordance with DIN EN ISO 11138-7:2019-11: Sterilization of healthcare products – Biological indicators – Part 7: Guidelines for the selection, use, and interpretation of results (ISO 11138-7:2019); German version EN ISO 11138-7:2019 from four individual samples using the heat shock method.

Our identification tests are based on validated methods and conducted under controlled conditions. All results are documented in a traceable manner and processed in accordance with GMP.

We reliably identify the spores of Geobacillus stearothermophilus strain on your BIs.

Spore identification is performed using an API® 50 CHB/E test from bioMérieux.

The API® 50 CHB/E test is used to characterize organisms based on their ability or inability to metabolize 50 specified substrates. The resulting positive-negative pattern is compared with a database and the organism is determined in this way.

The strain to be identified is also carried as a KWIK STIK™.

Gloved hands are shown handling a vial with a red liquid in a laboratory setting.The BIs were specifically developed for use in decontamination and sterilization processes.

The spores are applied as a monolayer on stainless steel carriers and sealed in Tyvek® envelopes for easier handling. Although this envelope is permeable to gaseous H2O2, it represents a diffusion barrier for the spore-inoculated carrier, thus creating a worst-case scenario.

After use, the carriers are transferred from the Tyvek® pouches into culture media and incubated. If no growth is observed after seven days, the effective decontamination process has killed all spores on the carrier.

We take care of the GMP-compliant documentation of your BI test results.

The validation of sterilization and decontamination processes depends on comprehensive documentation.
Our experts document the results in compliance with GMP – including test planning, methodology, result tables, and evaluation. Our reports meet the requirements of common inspection authorities (e.g.,
B. EMA, FDA) and serve as valid evidence during audits.
We also support you in interpreting the results and provide specific recommendations for further validation.

Yes! We offer certified BI products for your application.

These are preconfigured for typical applications, contain standardized numbers of bacterial spores, and are delivered with an individual generated test certificate.
You receive the product and accompanying documentation from a single source – tailored to your validation strategy. This option is particularly suitable for customers who want to combine external support with reliable product availability. Please contact us – we will work with you to determine whether this solution makes sense for your project.

Are you planning to use certified BIs?

Please contact us in time when you need BIs and accompanying or execution support for the process development and validation of your isolator.

We provide already certified BIs ore an initial qualification of your own BI batch and propose sufficiently characterized BIs for the development and validation process.

Take advantage of BIs assessed and characterized under real-time conditions in a pharmaceutical-scale isolator. This saves you time in the development and validation of the bio decontamination processes.

Free first consultation now!

Free first consultation now!

 

Dr. Ellen Sons-Brinkmann
Phone: +49 69 153 293 709

Contact us

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Our Company

Valicare is an ISO 9001-certified service company and operates in the area of qualification and validation of technical equipment and processes.