Standard Operating Procedure for Media Storage and Handling

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the proper storage and handling of microbiological growth media in the pharmaceutical manufacturing facility.

Scope

This SOP applies to all personnel involved in the storage, preparation, and use of microbiological growth media within the pharmaceutical facility.

Responsibilities

• Quality Control (QC) Department: Responsible for overseeing the implementation and compliance of this SOP.
• Laboratory Technicians: Responsible for preparing, storing, and handling microbiological growth media according to the procedures outlined in this SOP.
• Inventory Management: Responsible for maintaining adequate stock levels of media components and ensuring proper storage conditions.

Procedure

1. Receiving and Inspection:
   • Upon receipt, inspect incoming microbiological media for any signs of damage, contamination, or expiration.
   • Verify that the media components are properly labeled with expiration dates and storage conditions.
2. Storage Conditions:
   • Store microbiological media in a dedicated, temperature-controlled storage area away from direct sunlight and moisture.
   • Ensure that the storage temperature is within the recommended range specified by the manufacturer.
   • Organize media inventory based on expiration dates, with older stock placed in front for prioritized use.
3. Handling Procedures:
   • Handle microbiological media with care to avoid contamination and deterioration.
   • Use aseptic techniques when dispensing media components or preparing agar plates to prevent microbial contamination.
   • Close containers tightly after use to minimize exposure to air and moisture.
4. Labeling and Documentation:
   • Label all media containers with the date of receipt, expiration date, and any specific storage instructions.
   • Maintain accurate records of media inventory, including batch numbers, quantities, and usage logs.
5. Quality Control Checks:
   • Perform regular quality control checks on prepared media, including pH testing, sterility testing, and growth promotion testing.
   • Document the results of quality control tests and take appropriate corrective actions for any deviations observed.

Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control

Documents

• Media Inventory Log
• Quality Control Records
• Media Handling Training Materials

Reference

United States Pharmacopoeia (USP) General Chapter Microbiological Control of Drug Substances and Drug Products

SOP Version

Version 1.0