SOP For Operation and Calibration of the Showcase Chiller

This document details the procedure for 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 operation and calibration of Showcase chiller and Walk-in Cooling chamber in order 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  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.

PROCEDURE

OPERATION

Ensure that the  Showcase  Chiller/Walk-in cooling chamber is clean and free from dust.

Check the Power Point is ON/OFF.

Check the locking of the Showcase chiller/Walk-in cooling chamber. 

Open the door of Showcase Chiller / Walk-in a cooling chamber by using the handle provided. Check 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 Logbook of Showcase chiller on XYZ/CQA/SOP-049/FR-05 as Logbook of Showcase chiller (Appendix V) and for 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 calibrated digital thermometer attached with a probe.

Hang the probe(attached with a calibrated digital thermometer) with the shelf of the Showcase chiller/Walk-in cooling chamber.

Observe and note down the value of the external probe(for calibration) and displayed 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 Showcase chiller on XYZ/CQA/SOP-049/FR-01 (Appendix I) as Calibration record of Showcase chiller and for 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 Section  In charge.

Affix the calibration status tag on the Showcase chiller/Walk-in cooling chamber

Report any discrepancy observed during calibration of instrument to Section In-charge or his representative for corrective and preventive action.

Section In-charge or his representative will take the necessary action and report the same to Manager – Quality Assurance.

Affix ‘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