The purpose of this Standard Operating Procedure (SOP) is to describe the operation and Calibration of the Cold Chamber.
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 :
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).
- BASIC OPERATION:
- Switch ON the mains.
- Ensure the plc on 24 hours.
- To set the set value (SV) and present value (PV).
- Click on set value show the password keypad window.
- Enter the password and set the set value.
- To change the value and press enter key.
- 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.
- Click on back option.
- 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.
- Click on the short cut icon tomcat on desktop.
- Click the run option.
- Minimize the tomcat window.
- start tomcat software.
- open the daas software user name & password enter and open the software.
- 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.
- Generate the report and click on print option and get print.
- 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.
Frequency: Half Yearly
Carry out the calibration of temperature sensor by external party.
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 : Cold chamber cleaning record
- REFERENCES :
- REVISION HISTORY :
|Sr. No.||Revision No.||Change Control Number||Details of Revision||Reasons(s) for Revision|
|1||00||—-||New SOP||New SOP|