SOP For Operation and Calibration of the Cold Chamber

1.   OBJECTIVE: 

The purpose of this Standard Operating Procedure (SOP) is to describe the operation and Calibration of the Cold Chamber.

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.

4. PROCEDURE:
5. PRELIMINARY CHECK : 

4.1.1      Ensure that the cold chamber and shelves are clean. If not then clean   with a  non- shedding lint free duster or cloth dipped in disinfectant solution (wherever applicable). 

1. BASIC OPERATION:
   1. Switch ON the mains.
   2. Ensure the plc on 24 hours.
   3. To set the set value (SV) and present value (PV).
   4. Click on set value show the password keypad window.
   5. Enter the password and set the set value.
   6. To change the value and press enter key.
   7. Set the print frequency. Click the Menu option show the the sub option print frequency click on show the password keypad window enter the password and change master print frequency.
   8. Click on back option.
   9. Using the Cold Chamber open and close within 5 minutes if the more time use the chamber show the error key red colour and beep the alarm; then acknowledge that. 
   10. Click on the short cut icon tomcat on desktop.
   11. Click the run option.
   12. Minimize the tomcat window.
   13. start tomcat  software.
   14. open the daas software  user name & password enter and open the software.
   15. It shows multiple options in which enter the analysis option it also shows four option in which select the master tubular option that contain from date , to date, chamber id, report format fill all these option and click on submit.
   16. Generate the report and click on print option and get print.
   17. Prints taken at every morning; at the time of holiday print taken on next day.

4.4 MAINTENANCE OF RECORDS:

                Record the temperature of refrigerator and deep freezer as per Annexure I.

4.5 CALIBRATION:

                Frequency: Half Yearly

               Carry out the calibration of temperature sensor by external party.

4.6 VALIDATION:

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

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

4.7          CLEANING:

                Frequency:  Weekly

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  :                    Cold chamber cleaning record

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