Standard Operating Procedure for Bioburden Testing

Purpose:

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines and procedures for determining the microbial bioburden in raw materials or finished products within the pharmaceutical manufacturing facility. This helps ensure compliance with regulatory requirements and product safety standards.

Scope

This SOP applies to all personnel involved in bioburden testing procedures within the pharmaceutical manufacturing facility.

Responsibilities

• Quality Control (QC) Department: Responsible for overseeing the implementation and compliance of this SOP.
• Microbiologist: Responsible for performing bioburden testing according to the procedures outlined in this SOP.
• Production Personnel: Responsible for providing samples for bioburden testing and ensuring proper documentation.

Procedure

1. Sample Collection and Preparation:
   • Collect representative samples of raw materials or finished products to be tested.
   • Prepare samples according to specified methods and dilutions, if required.
2. Inoculation and Incubation:
   • Inoculate suitable culture media with the prepared samples using aseptic techniques.
   • Incubate cultures under specified conditions to promote microbial growth.
   • Incubation periods may vary depending on the type of sample and regulatory requirements.
3. Enumeration of Microorganisms:
   • Count microbial colonies using suitable enumeration techniques such as pour plate or membrane filtration.
   • Record colony counts and calculate the bioburden level per unit of sample.
4. Identification of Microorganisms:
   • Perform biochemical tests or other identification methods to characterize microbial isolates, if required.
   • Record and interpret identification results as per regulatory guidelines.
5. Documentation and Reporting:
   • Document all test results, observations, and calculations accurately and legibly.
   • Report bioburden testing results to the appropriate personnel and maintain records as per regulatory requirements.

Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control

Documents

• Bioburden Testing Records
• Incubation Log
• Identification Results

Reference

United States Pharmacopoeia (USP) General Chapter Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests

SOP Version

Version 1.0