Standard Operating Procedure for Process Chiller
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Process Chiller 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 Process Chiller in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the Process Chiller as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the temperature and quality of chilled processes.
Maintenance Personnel: Responsible for maintaining the Process Chiller in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Process Chiller 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 Process Chiller and surrounding area.
4.1.2.2 Check the coolant level and refill if necessary.
4.1.2.3 Ensure the chiller is properly connected to the equipment requiring cooling.
4.2 Operation
4.2.1 Starting the Chiller
4.2.1.1 Turn on the power switch and set the desired temperature on the controller.
4.2.1.2 Allow the chiller to stabilize and reach the set temperature.
4.2.1.3 Monitor the temperature closely during operation.
4.2.2 Chilling Process
4.2.2.1 Ensure continuous monitoring of the chilled equipment temperature.
4.2.2.2 Adjust the chiller 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 chiller temperature setting after use.
4.2.3.2 Allow the chiller to cycle off and stabilize.
4.2.3.3 Disconnect the chiller from the equipment and power source.
4.3 Post-operation
4.3.1 Maintenance
4.3.1.1 Clean the chiller 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 Process Chiller
Pharmacopeial guidelines for pharmaceutical cooling processes
8) SOP Version
Version 1.0
