Standard Operating Procedure for Using Cryogenic Freezer
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the cryogenic freezer in the pharmaceutical manufacturing of otic dosage forms to ensure proper storage conditions at ultra-low temperatures.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of cryogenic freezers in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the cryogenic freezer as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring temperature and storage conditions.
Maintenance Personnel: Responsible for maintaining the cryogenic freezer in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the cryogenic freezer for cleanliness and integrity before use.
4.1.1.2 Ensure that temperature monitoring devices are functional and calibrated.
4.1.1.3 Check that the freezer racks and containers are clean and suitable for storage.
4.1.2 Preparation
4.1.2.1 Load samples or materials into suitable storage containers or racks.
4.1.2.2 Place the containers or racks securely inside the cryogenic freezer.
4.1.2.3 Set the temperature and monitoring parameters on the freezer control panel.
4.2 Operation
4.2.1 Setting the Controls
4.2.1.1 Power on the cryogenic freezer and set the desired temperature.
4.2.1.2 Monitor the temperature display to ensure the freezer reaches and maintains the set temperature.
4.2.1.3 Adjust the temperature settings if necessary to maintain storage conditions.
4.2.2 Safety Precautions
4.2.2.1 Wear appropriate personal protective equipment (PPE) when handling cryogenic freezers.
4.2.2.2 Handle samples with care to prevent spills or contamination.
4.2.2.3 Follow all safety protocols for working with ultra-low temperatures.
4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Power off the cryogenic freezer after completing the storage process.
4.3.1.2 Remove samples or materials from the freezer as needed.
4.3.1.3 Clean the freezer racks and containers with appropriate disinfectants.
4.3.2 Maintenance
4.3.2.1 Regularly defrost and clean the cryogenic freezer according to manufacturer guidelines.
4.3.2.2 Inspect seals and gaskets for wear and replace as necessary.
4.3.2.3 Calibrate temperature monitoring devices periodically.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
6) Documents, if any
Temperature log
Freezer maintenance records
7) Reference, if any
Manufacturer’s manual for the cryogenic freezer
Pharmacopeial guidelines for storage of pharmaceutical products at ultra-low temperatures
8) SOP Version
Version 1.0
