Do you require certified BIs for the validation of sterilization or decontamination processes?

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™.

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.