Standard Operating Procedure for Culture Preservation

Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the preservation of microbial cultures for long-term storage in the pharmaceutical manufacturing facility.

Scope

This SOP applies to all personnel involved in the preservation of microbial cultures, including microbiologists, laboratory technicians, and quality assurance personnel.

Responsibilities

• Microbiology Department: Responsible for overseeing the implementation and compliance of this SOP.
• Microbiologists: Responsible for preserving microbial cultures according to the procedures outlined in this SOP.
• Laboratory Technicians: Responsible for assisting with culture preservation procedures and maintaining accurate records.

Procedure

1. Selection of Culture Media:
   • Select appropriate culture media and supplements suitable for the long-term storage of microbial cultures.
   • Ensure that the selected media provide adequate nutrients and conditions to maintain the viability of the cultures over time.
2. Inoculation and Growth:
   • Inoculate the selected culture media with the microbial cultures to be preserved using aseptic techniques.
   • Incubate the inoculated media under appropriate conditions to allow for the growth and development of the cultures.
3. Culture Stabilization:
   • Stabilize the cultures by adding cryoprotectants or other additives to enhance their resistance to freezing and thawing.
   • Adjust the pH and osmotic pressure of the culture medium to optimize the preservation process.
4. Storage Conditions:
   • Transfer the stabilized cultures into appropriate storage containers, such as cryovials or ampules, for long-term storage.
   • Label each storage container with relevant information, including the culture identifier, date of preservation, and storage conditions.
5. Storage and Retrieval:
   • Store the preserved cultures in a dedicated storage facility equipped with temperature monitoring and backup systems.
   • Establish a systematic storage and retrieval system to facilitate easy access to preserved cultures when needed.

Abbreviations

• SOP: Standard Operating Procedure

Documents

• Culture Preservation Log
• Storage Inventory Records
• Culture Preservation Protocols

Reference

United States Pharmacopoeia (USP) General Chapter Microbiological Control and Monitoring of Aseptic Processing Environments

SOP Version

Version 1.0