The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Operation and Calibration of the Refrigerator.
This SOP is applicable to Quality Control Department at manufacturing facility.
- Officer/ Executive shall be responsible for the effective handling, operation, maintenance, calibration and validation of the refrigerator as per procedure.
- Head of Quality Control Department shall be responsible for the effective implementation of the procedure.
- PRELIMINARY CHECK :
- Ensure that the Refrigerator and shelves are clean. If not then clean with a non- shedding lint free duster or cloth dipped in disinfectant solution (wherever applicable).
- The distance between air outlet and side wall should be at least 200 mm.
- BASIC OPERATION:
- Switch ON the mains.
- Prior to loading the refegirator, leave it ‘ON’ for 2-3 hours.
- Set the refrigerator to achieve a temperature of 2o C to 8o C in the refrigerator, and -10oC to -25oC in the deep freezer using provided knob.
- Place shelves at required height.
- Close the door of the refrigerator.
- Do not open the door frequently.
Note: At the time of withdrawing the container from the refrigerator ensure that the refrigerator will not remain open for longer time to maintain the temperature condition inside the refrigerator.
4.3 MAINTENANCE OF RECORDS:
Record the temperature of refrigerator and deep freezer as per Annexure I.
Carry out the calibration of temperature sensor by external party.
|Sr. No.||Parameters||Acceptance Criteria|
|01||Digital Temperature controller with sensor||± 2.0º C|
Frequency: yearly or after any major modification or major repairing is done.
Carry out the temperature distribution study by an approved external party.
Trainer : Head – Quality Control
Trainees : Analyst / Section Heads
Controlled Copy No.1 : Head of Department – Quality Assurance
Controlled Copy No.2 : Head of Department – Quality Control
Original Copy : Head – Quality Assurance
- ANNEXURES :
Annexure I: Record the temperature of refrigerator and deep freezer
- REFERENCES :
- REVISION HISTORY :
|Sr. No.||Revision No.||Change Control Number||Details of Revision||Reasons(s) for Revision|
|1||00||———–||New SOP||New SOP|