Standard Operating Procedure for Media Preparation

Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for preparing microbiological growth media in a consistent and standardized manner to support microbial testing activities within the pharmaceutical manufacturing facility.

Scope

This SOP applies to all personnel involved in the preparation of microbiological growth media within the microbiology laboratory.

Responsibilities

• Microbiologist: Responsible for overseeing and performing media preparation activities.
• Quality Assurance (QA) Department: Responsible for ensuring compliance with this SOP.
• Laboratory Technician: Responsible for following the procedures outlined in this SOP.

Procedure

1. Materials and Equipment:
   • Gather all necessary materials and equipment required for media preparation, including ingredients, glassware, and sterile containers.
2. Media Formulation:
   • Follow the specific formulation and recipe provided for the type of media being prepared.
   • Weigh and measure each ingredient accurately using calibrated weighing equipment.
3. Media Sterilization:
   • Prepare the media according to the manufacturer’s instructions or standard protocols.
   • Autoclave the media at the appropriate temperature and pressure for the specified duration to achieve sterilization.
4. Cooling and Dispensing:
   • Allow the sterilized media to cool to the desired temperature in a controlled environment.
   • Dispense the media into sterile containers using aseptic techniques to prevent contamination.
5. Labeling and Storage:
   • Label each container with the media type, batch number, preparation date, and expiration date.
   • Store the prepared media under appropriate conditions to maintain stability and sterility.

Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance

Documents

• Media Formulation Recipes
• Media Preparation Log
• Equipment Calibration Records

Reference

USP General Chapter Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests

SOP Version

Version 1.0