This document details the procedure for the Operation and Calibration of the Showcase Chiller and Walk-in cooling chamber.
Scope
It is the policy of Xyz Pharmaceuticals Limited that the written procedure shall be followed for the operation and calibration of the Showcase chiller and Walk-in Cooling chamber to ensure smooth operation and its use monitored to ensure that the instrument gives consistently accurate and reproducible results in compliance with regulatory requirements.
This procedure is to be applied at the time of Operation and Calibration of the Showcase Chiller and Walk-in cooling chamber.
RESPONSIBILITY
Persons along with their responsibilities are given below:
Executive — Corporate/Quality Assurance:- To prepare the SOP
Trainee Analyst/ Jr. Analyst/ Analyst/ Sr. Analyst:- To follow the SOP accordingly
Manager — Quality Control:- To ensure implementation of SOP.
Operation and Calibration of the Showcase Chiller
OPERATION
Ensure that the Showcase
Chiller/Walk-in cooling chamber is clean and free from dust.
Check the PowerPoint is ON/OFF.
Check the locking of the Showcase chiller/Walk-in cooling chamber.
Open the door of the Showcase Chiller / Walk-in cooling chamber by using the handle provided. Check whether the light is working or not.
Check the temperature of the Walk-in cooling chamber / Showcase Chiller on display mode.
Use the provided Shelves as per your requirement.
Close the door and check the lock.
Maintain the Logbook of the Showcase chiller on XYZ/CQA/SOP-049/FR-05 as the Logbook of the Showcase chiller (Appendix V) and for the Walk-in Cooling chamber on XYZ/CQA/SOP-049/FR-06 as Logbook of Walk-in Cooling Chamber (Appendix VI).
Maintain the Daily temperature Monitoring
record of the Showcase chiller on XYZ/CQA/SOP-049/FR-03(Appendix III) and for the Walk-in cooling chamber on XYZ/CQA/SOP-049/FR-04 (Appendix IV)
Calibration (Frequency: quarterly)
Use a calibrated digital thermometer attached
to a probe.
Hang the probe(attached with a calibrated
digital thermometer) on the shelf of the Showcase chiller/Walk-in cooling chamber.
Observe and note down the value of the external probe(for calibration) and display the value of the inbuilt thermometer.
Repeat step for all the
shelves/Racks of the Showcase Chiller and Walk-in cooling chamber
Record the calibration data for the Showcase
chiller on XYZ/CQA/SOP-049/FR-01 (Appendix I) as the Calibration record of Showcase
chiller and for the Walk-in cooling chamber on XYZ/CQA/SOP-049/FR-02 (Appendix II)
as calibration record of Walk-in cooling chamber.
Compare the result with acceptance criteria and take valid calibration authorization from the Section In charge.
Affix
the calibration status tag on the Showcase chiller/Walk-in cooling chamber
Report
any discrepancy observed during the calibration of the instrument to the Section In-charge
or his representative for corrective and preventive action.
The section In-charge or his representative
will take the necessary action and report the same to the Manager – Quality
Assurance.
Affix the ‘Under Maintenance’ label on the Showcase chiller/Walk-in cooling chamber.
Precautions
Take the reading when the Showcase chiller/Walk-in cooling chamber has attained constant temperature in the chamber.
Check the Calibration of the Thermometer.
Always
place a thermometer in such a way, As not to touch the surface of the dipping bottle.
Handle
the showcase chiller/walk-in cooling chamber carefully.
Disconnect
the Showcase chiller /Walk-in cooling chamber at the time of cleaning.
Download: Logbook and Appendix-I, II, III