SOP FOR MICROBIOLOGICAL ANALYSIS OF WFI (Water for Injection)

Objective: To ensure the quality and safety of Water for Injection (WFI) through microbiological
analysis.

Scope: This SOP applies to all personnel involved in the microbiological analysis of WFI.

Procedure:

Sample Collection:

a. Collect WFI samples aseptically in sterile containers.

b. Ensure proper labeling with sample details including date and time of collection.

Laboratory Setup:

a. Ensure the laboratory is clean and free from contamination.

b. Sterilize all equipment and materials to be used.

Microbiological Analysis:

a. Perform microbial tests such as Total Viable Count (TVC) and Endotoxin testing following
established protocols.

b. Record test results accurately.

Data Analysis:

a. Compare test results with established specifications.

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

Reporting:
a. Prepare a microbiological analysis report, including all test results and any deviations.

b. Maintain records as per regulatory requirements.

Equipment Maintenance:

a. Regularly calibrate and maintain all equipment used for analysis.

b. Document equipment maintenance activities