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 or not they are inactivated. The degree of inactivation can be derived as the quality of decontamination.
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.
- How many biological indicators are used for a reliable Total Kill Test?
According to the proven quality control test, around 101 biological indicators are needed for a valid Total Kill Test. SKANs years of experience have shown that this number provides the best and most reliable results.
- How is the inactivation state of the biological indicators analyzed?
After H2O2 decontamination, the biological indicators are incubated individually in tubes containing Trypcase Soy Broth (TSB). Those that are not fully inactivated turbid the TSB and a quality level of decontamination can be obtained. It should be ensured that the turbidity is not due to inhomogeneity of the batch of biological indicators.
- What is the volume of the tubes used?
The tubes used to incubate the biological indicators are each filled with 9 mL of Trypcase Soy Broth (TSB). This amount is required to perform a valid testing process.