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
- 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.
- 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.
- 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.
- 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.
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