SOP For Operation and Calibration of Refrigerator.

1.   OBJECTIVE: 

The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Operation and Calibration of the Refrigerator.

2.   SCOPE:

This SOP is applicable to Quality Control Department at manufacturing facility.    

3.   RESPONSIBILITY:  

1.   Officer/ Executive shall be responsible for the effective handling, operation, maintenance, calibration and validation of the refrigerator as per procedure.
2. Head of Quality Control Department shall be responsible for the effective    implementation of the procedure.
3. PROCEDURE:

1. PRELIMINARY CHECK : 
2. 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). 
3. The distance between air outlet and side wall should be at least 200 mm.

2. BASIC OPERATION:

1. Switch ON the mains.
2. Prior to loading the refegirator, leave it ‘ON’ for 2-3 hours.
3. Set the refrigerator to achieve a temperature of 2^o C to 8^o C in the refrigerator, and   -10^oC to -25^oC in the deep freezer using provided knob.
4. Place shelves at required height.
5. Close the door of the refrigerator.
6. 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.

4.4 CALIBRATION:

                Frequency: Yearly

               Carry out the calibration of temperature sensor by external party.

Sr. No.	Parameters	Acceptance Criteria
01	Digital Temperature controller with sensor	± 2.0º C

4.5 VALIDATION:

Frequency: yearly or after any major modification or major repairing is done.

Carry out the temperature distribution study by an approved external party.   

5.     TRAINING: 

Trainer : Head – Quality Control

Trainees :  Analyst / Section Heads 

6.   DISTRIBUTION: 

Controlled Copy No.1 :  Head of Department – Quality Assurance 

Controlled Copy No.2 :  Head of Department – Quality Control

Original Copy :  Head – Quality Assurance 

7.   ANNEXURES : 

Annexure I: Record the temperature of refrigerator and deep freezer

8.   REFERENCES :

Nil

9.   REVISION HISTORY : 

Sr. No.	Revision No.	Change Control Number	Details of Revision	Reasons(s) for Revision
1	00	———–	New SOP	New SOP