Standard Operating Procedure for Recirculating Cooler
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Recirculating Cooler used in the pharmaceutical manufacturing of otic dosage forms to ensure efficient cooling and temperature control.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the Recirculating Cooler in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the Recirculating Cooler as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the temperature and quality of chilled processes.
Maintenance Personnel: Responsible for maintaining the Recirculating Cooler in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Recirculating Cooler for cleanliness and integrity before use.
4.1.1.2 Ensure all connections, hoses, and fittings are secure and functional.
4.1.1.3 Verify that all safety devices and interlocks are functioning properly.
4.1.2 Preparation
4.1.2.1 Clean and sanitize the Recirculating Cooler and surrounding area.
4.1.2.2 Check the coolant level and refill if necessary.
4.1.2.3 Ensure the cooler is properly connected to the equipment requiring cooling.
4.2 Operation
4.2.1 Starting the Cooler
4.2.1.1 Turn on the power switch and set the desired temperature on the controller.
4.2.1.2 Allow the cooler to stabilize and reach the set temperature.
4.2.1.3 Monitor the temperature closely during operation.
4.2.2 Cooling Process
4.2.2.1 Ensure continuous monitoring of the cooled equipment temperature.
4.2.2.2 Adjust the cooler settings as necessary to maintain the required cooling.
4.2.2.3 Record temperature readings and any observations in the logbook.
4.2.3 Shutting Down
4.2.3.1 Gradually reduce the cooler temperature setting after use.
4.2.3.2 Allow the cooler to cycle off and stabilize.
4.2.3.3 Disconnect the cooler from the equipment and power source.
4.3 Post-operation
4.3.1 Maintenance
4.3.1.1 Clean the cooler surfaces and check for any leaks or residue.
4.3.1.2 Inspect the coolant levels and refill or replace coolant as needed.
4.3.1.3 Perform preventive maintenance as per manufacturer’s guidelines.
4.3.1.4 Document all maintenance activities and update records accordingly.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
6) Documents, if any
Batch records for each cooling batch
Maintenance records
Coolant replacement and temperature calibration records
7) Reference, if any
Manufacturer’s manual for the Recirculating Cooler
Pharmacopeial guidelines for pharmaceutical cooling processes
8) SOP Version
Version 1.0
