Standard Operating Procedure (SOP) for Bioburden Testing

Objective: To define the procedure for conducting bioburden testing in accordance with regulatory
requirements and company standards.

Scope

This SOP applies to all bioburden testing activities conducted within the organization.

Responsibilities

Specify the roles and responsibilities of personnel involved in bioburden testing.

Materials and Equipment

List the materials, reagents, and equipment required for bioburden testing.

Provide procedures for equipment maintenance and calibration.

Sample Collection

Describe the procedure for collecting samples for bioburden testing.

Include aseptic techniques and sample handling guidelines.

Testing Procedure

Detail the steps involved in the bioburden testing process.

Specify incubation conditions, media, and culture methods.

Data Recording

Explain how test data should be recorded, including sample identification, test results, and any
deviations.

Data Analysis

Describe how to interpret test results and determine bioburden levels.

Include criteria for acceptance or rejection based on established limits.

Reporting
Define the format and content of bioburden test reports.

Include requirements for documentation and record retention.

Quality Control

Outline procedures for quality control checks during bioburden testing.

Include corrective actions for out-of-specification results.

Safety

Include safety precautions and guidelines for handling potentially hazardous materials.