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Biological Indicator Population Verification

Biological Indicator Population Verification

The Biological Indicator Population Verification test determines the number of spores on a biological indicator (BI) and is typically used to verify the BI manufacturer’s labeled population. This test can also be used to enumerate survivors from a sterilization process to determine lethality rates and D-values. 

Initial population verification is necessary because the population of the BIs can change during shipping and/or storage. Population enumeration on samples exposed to the sterilant is also important because it provides quantitative data whereas a BI sterility test only provides growth/no growth results.

Testing requirements are outlined in USP <55> and ISO 11138. Our experts have the capability to perform testing on all types of biological indicator configurations such as BI strips, disks, stainless steel sutures, inoculated wires, and spore suspensions and can offer one-on-one guidance. Please contact our Study Director for more details on the standards, samples, and testing requirements appropriate for your product.

Applicable Standards

  • ISO 11138
  • USP 55

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test TAT (days) Request Quote
BPV110 BI Population Verification (USP), Pooled Results, 4 BIs 10 Add
BPV120 BI Population Verification (USP), Individual Results, 4 BIs 10 Add
BPV125 BI Population Verification (ISO), Pooled Results, 4 BIs 10 Add
BPV130 BI Population Verification (ISO), Individual Results, 4 BIs 10 Add
BPV110 - BI Population Verification (USP), Pooled Results, 4 BIs
TAT: 10 days
BPV120 - BI Population Verification (USP), Individual Results, 4 BIs
TAT: 10 days
BPV125 - BI Population Verification (ISO), Pooled Results, 4 BIs
TAT: 10 days
BPV130 - BI Population Verification (ISO), Individual Results, 4 BIs
TAT: 10 days

Sample Specifications

BPV110: Minimum 4 BIs
BPV120: Minimum 4 BIs
BPV125: Minimum 3 BIs
BPV130: Minimum 4 BIs

Study Outline

In Biological Indicator Population Verification testing, BIs are macerated using a validated technique such as blending or by sterile glass beads. Other methods can be used as required. After heat shocking, the
suspension is diluted to yield colonies in the range of 30–300 colony-forming units (CFU) and then plated.
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