SOP FOR QUALIFICATION OF BIOLOGICAL INDICATORS

Objective: To establish a process for qualifying biological indicators used for sterilization validation.

Scope: This SOP applies to personnel responsible for the qualification of biological indicators.

Procedure:

Selection of Biological Indicators:

a. Choose appropriate biological indicators based on the sterilization method being validated.

b. Ensure that the selected indicators represent the most resistant microorganisms for the given
process.

Biological Indicator Preparation:

a. Follow manufacturer instructions for the preparation and activation of biological indicators.

b. Use aseptic techniques during the preparation process to prevent contamination.

Inoculation:

a. Inoculate the selected biological indicators with a standardized population of the test
microorganism.

b. Ensure the inoculation process mimics the conditions of the sterilization process as closely as
possible.

Incubation:

a. Incubate the inoculated biological indicators under conditions specified by the manufacturer.

b. Monitor the incubation period and ensure proper temperature and humidity control.

Biological Indicator Evaluation:

a. After incubation, examine the biological indicators for growth or lack thereof.

b. Interpret results according to predetermined acceptance criteria.

Documentation:
a. Maintain detailed records of the qualification process, including inoculation and incubation data.

b. Record results and whether the biological indicators met acceptance criteria.