The Biological Indicator Population Verification test determines the number of spores on a biological indicator (BI) and is typically used to validate the BI manufacturer's labeled population. This test can also be used to enumerate survivors of a sterilization process to determine mortality and D-values.
Initial population verification is required because the population of BIs may change during transportation and / or storage. The census on samples exposed to the sterilizer is also important because while providing quantitative data, a BI sterility test only provides growth / no growth results.
Test requirements are outlined in USP <55> and ISO 11138. Our experts are capable of testing on any biological indicator configuration such as BI strips, discs, stainless steel stitches, grafted wires and spore suspensions, and can offer one-to-one guidance. Please contact our experts for more information on standards, samples and testing requirements applicable to your product.
Applicable Standards
Sample Features
Working Draft
Biological Indicator Population When performing validation testing, BIs are softened using a validated technique such as mixing or sterile glass beads. This maceration is then subjected to heat shock and the suspension is diluted to give colonies in the range of 30–300 colony forming units (CFU) and then plated. Other methods can be used as needed.
EUROLAB, with its highly expert team and internationally accredited laboratories, Verification Test of Biological Population It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
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