SOP FOR BIOBURDEN TEST

Objective: To determine the level of microbial contamination (bioburden) in a sample.

Scope: This SOP applies to all personnel involved in conducting bioburden tests.

Procedure:

Sample Preparation:

a. Obtain the sample aseptically and transfer it to a sterile container.

b. Ensure proper labeling with sample details.

Inoculation:

a. Inoculate the sample onto suitable agar plates or into broth, as per established procedures.

b. Incubate the samples under appropriate conditions.

Enumeration:

a. After incubation, count the visible colonies on the agar plates.

b. Calculate the bioburden based on the counts obtained.

Data Analysis:

a. Compare bioburden results with established specifications.

b. Investigate and document any out-of-specification results.

Reporting:

a. Prepare a bioburden test report, including all test results and any deviations.
b. Maintain records as per regulatory requirements