Standard Operating Procedure for Microbial Culturing

Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines and procedures for culturing microorganisms from samples in the pharmaceutical manufacturing facility.

Scope

This SOP applies to all personnel involved in microbial culturing 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 microbial culturing procedures according to the instructions outlined in this SOP.
• Production Personnel: Responsible for providing samples for microbial culturing and ensuring proper documentation.

Procedure

1. Sample Collection:
   • Collect samples from designated sampling points using aseptic techniques and sterile containers.
   • Ensure proper labeling and identification of each sample.
2. Inoculation of Culture Media:
   • Inoculate suitable culture media with the collected samples using aseptic techniques.
   • Ensure proper distribution of the samples on the surface of the media.
3. Incubation:
   • Incubate the inoculated culture media under appropriate conditions (temperature, duration) for microbial growth.
   • Monitor cultures regularly for signs of microbial growth and contamination.
4. Subculture and Identification:
   • If necessary, subculture microbial isolates onto selective media to obtain pure cultures.
   • Perform biochemical tests, molecular techniques, or other identification methods to characterize microbial isolates.
5. Documentation and Reporting:
   • Document all culturing activities including sample collection, inoculation, incubation parameters, and identification results.
   • Report culturing results to the appropriate personnel and maintain records as per regulatory requirements.

Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control

Documents

• Sample Collection Log
• Culture Media Preparation Records
• Incubation Log
• Microbial Identification Results

Reference

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

SOP Version

Version 1.0