Biological indicators are test systems based on viable microorganisms and their defined resistance to specific decontamination procedures. This microbiological method shows the results of decontamination and sterilization immediately and directly without reference parameters. Biological indicators are currently used for validation and routine control of all common decontamination procedures.
SKAN BI® are specifically designed for use in demanding industrial H2O2 decontamination processes. Each stainless steel carrier is provided with certified bacterial spores of Geobacillus stearothermophilus. Each carrier is individually wrapped in a non-woven flashpun of high density polyethylene fiber material. SKANs unique design and manufacturing processes ensure reliable and unsurpassed quality of biological indicators.
The distinctive features of SKAN BI®
- Fully validated production and quality controls with biological indicators.
- SKAN BI® can be removed from the primary packaging without risk of touching the inoculated area.
- Easy positioning of biological indicators in the system with tape or hooks.
- Clear carrier design to facilitate transfer into the nutrient broth.
- Continuous scientific and technological development of biological indicators.
- Customer support from our experts.
Providing the appropriate biological indicator for each process
In order to provide the right biological indicators for each process, SKAN has developed three standard variants which can be used depending on the individual process. The biological indicators differentiate themselves by the number of certified Geobacillus stearothermophilus spores.
- SKAN BI® – DSM5934 – 10e6
(minimum of 1,000,000 bacterial spores) - SKAN BI® – DSM5934 – 10e5
(minimum of 100,000 bacterial spores) - SKAN BI® – DSM5934 – 10e4
(minimum of 10,000 bacterial spores)
Our experts professionally support you in implementing the decontamination process suitable for your plant using the right biological indicator.
Get in touch with our SKAN BI® team!
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Related Services
Viable Spore Count (VSC)
Evaluation of the spore population on biological indicators
Viable Spore Count (VSC)
Evaluation of the spore population on biological indicators
In order to be able to determine the quality of decontamination tests, SKAN has developed a method for counting viable, isolated spores. The method is based on the scientific principle that spores are capable of germination and growth on solid culture media, and that each microbial colony-forming unit (CFU) represents a direct progeny of a single spore in the original inoculum.
This is done by serial dilution of the spore in a suitable medium after resuspension from the carrier. The final dilution is then plated out on a suitable medium. After the spores have grown into colonies on this medium, they are counted. The Viable Spore Count results correspond to the amount of Geobacillus stearothermophilus spores that were initially inoculated on the biological indicator.
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D-Value Determination
Determination of the spore’s resistance on biological indicators
D-Value Determination
Determination of the spore’s resistance on biological indicators
The decimal reduction time describes the amount of time required to kill 90 % of a specific microorganism. This time period is referred to as the D-Value. The determination of this D-Value is a mandatory requirement for the quality control of batches of biological indicators. The D-Value determination determines the informative value of the biological indicators, which are subsequently used to verify the H2O2-based decontamination.
The SKAN Laboratories team is experienced in the determination of the D-Value and performs all control procedures based on recognized standards.
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D-Value Estimation
Evaluation of the spore’s resistance on biological indicators
D-Value Estimation
Evaluation of the spore’s resistance on biological indicators
The D-Value, or decimal reduction time, represents the time required to inactivate 90 % of a given microorganism under particular conditions. If fewer biological indicators are tested than the D-value determination requires, the result is a reasonable estimate that can be used as a basis for quality control of a batch of biological indicators.
The quality control team of SKAN Laboratories offers a D-Value estimation based on recognized standards. Testing takes place exclusively in SKANs H2O2 decontamination facility to simulate real conditions.
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Total Kill Test
Confirmation of biological indicator’s resistance homogeneity
Total Kill Test
Confirmation of biological indicator’s resistance homogeneity.
In order to reliably answer the question about the quality of a decontamination based on H2O2, the batch of the biological indicator must be homogeneous with respect to existing resistances. For the test, the biological indicators are placed in the plant or isolator and the well-known decontamination procedure is performed as standard. The indicators are then analyzed to determine whether they are inactivated. The degree of inactivation can be derived as the quality of decontamination.
The SKAN Laboratories quality control team performs the Total Kill Test based on recognized standards with high quality documentation using a reference SKAN H2O2 decontamination system.
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Microbiological Identification
Confirmation of the bacterial species on biological indicators
Microbiological Identification
Confirmation of the bacterial species on biological indicators.
The quality of control tests of H2O2 decontamination processes strongly depends on the used microorganism. Therefore, biological indicators are always certified with an underlying strain.
Since biological indicators are to be used without a special containment facility, bacterial spores are required that retain their resistance properties over the specified shelf life. Bacterial spores of Geobacillus species are therefore usually used for biological indicators.
The quality control team of SKAN Laboratories provides appropriate test methods to control the microorganisms used for biological indicators and to document their use based on recognized standards.