Operating, Cleaning and Calibrating Procedure for Refrigerator

1. OBJECTIVE
To lay down the procedure for operation, cleaning and calibration of Refrigerator

2. SCOPE
This procedure is applicable to Quality Control Department

3. RESPONSIBILITY
• Officer QC
• Manager QC

4. SAFETY INSTRUCTIONS
• Proper handling the instrument.
• Don’t switch on the main board with wet hands

5. PROCEDURE
5.1 OPERATION
5.1.1 Connect the power plug to the main power sockets and switch on the power supply.
5.1.2 Put thermometers in the refrigerator compartment and freezer.
5.1.3 Set the thermostat control knob to ‘NORMAL’ position.
5.1.4 Load the refrigerator with the items to be stored between 2-6°C.
5.1.5 In case the temperature (2-6°C for the chamber) is not achieved increase cooling by setting the thermostat to ‘MAX’ position.
5.1.6 To take out the articles, open the door of refrigerator & take out the articles and close the door again.
5.1.7 Monitor the temperature once a day in the format.
Limit:
Deep freezer: 3° C ± 2° C
Refrigerator: 4° C ± 2° C
5.2 CLEANING
5.2.1 For cleaning disconnect the electric supply, transfer the items or keep in another freezer.
5.2.2 Wipe the outer surface with a dry clean cloth and wipe out inner surface with detergent followed with purified water
5.2.3 Switch on the refrigerator and arrange the contents in an orderly manner.
5.3 CALIBRATION
Frequency: Daily
5.3.1 Temperature Mapping
5.3.2 Uniformity of temperature in the refrigerator should be checked by placing sufficient number (As designated in the validation program) of calibrated data loggers in the different positions of the shelves inside the refrigerator.
5.3.3 The data loggers to be placed in the positions programming to record data at a defined interval. After completion of the data recording for one hour, take out the data loggers and print the data and transfer data of 10 min, 20 min, 30 min, & 60 min to Annexure.
5.3.4 Or this all can be done by placing digital thermometer in 3 different points and recording their temperature after different time intervals
5.3.5 Repeat the above at empty, minimum load and maximum load condition (During initial qualification).

6. RELATED DOCUMENTS
Operational Log Book Format – Annex I
Cleaning Log Book Format- Annex II
Calibration Report Format – Annex III

7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.

8. ABBREVIATIONS
Q.C Quality Control Department
SOP Standard Operating Procedure

9. REVISION HISTORY