SOP For Cleaning, Maintenance, and Calibration of Stability Chamber

SOP For Cleaning, Maintenance, and Calibration of Stability Chamber

1.0 Objective

1.1 To establish a procedure for the cleaning, maintenance, and calibration of stability chambers to ensure their proper functioning and reliability for stability studies.

2.0 Scope

2.1 This SOP is applicable to all stability chambers used in the Quality Control Department for storage of stability samples.

3.0 Responsibility

3.1 QC Chemist or Above

• Responsible for routine cleaning, monitoring, and documentation of stability chambers.

3.2 Electrician or Above – Engineering Department

• Responsible for maintenance, troubleshooting, and technical support of stability chambers.

4.0 Accountability

4.1 Head – Quality Control

• Accountable for ensuring compliance with cleaning and calibration requirements.

4.2 Head – Engineering

• Accountable for ensuring timely maintenance and proper functioning of stability chambers.

5.0 Procedure

5.1 Cleaning

5.1.1 The external surface of the stability chamber shall be cleaned daily.

5.1.2 The boiler tank shall be cleaned weekly or after any maintenance activity.

5.1.3 The water reservoir tank shall be cleaned weekly or after maintenance.

5.1.4 The boiler heater shall be cleaned weekly or after maintenance.

5.1.5 The PT-100 sensor tip shall be cleaned once every three (3) months using suitable polishing paper.

5.1.6 The condenser, condenser motor, and radiator shall be cleaned once every three (3) months using compressed air.

5.1.7 The control panel shall be cleaned once every three (3) months by blowing air.

5.1.8 All cleaning activities shall be recorded in the Stability Chamber Cleaning Record as per Annexure.

5.2 Maintenance

5.2.1 Any malfunction or abnormality observed in the stability chamber shall be immediately reported to the Engineering Department, and a Maintenance Work Permit shall be raised as per Annexure.

5.2.2 The chamber fan and condenser fan shall be checked once every three (3) months and tightened if found loose.

5.2.3 The safety cut-off system shall be verified once every three (3) months by applying external heat to the dry bulb sensor.

5.2.4 Maintenance activities shall be carried out whenever any issue is identified in the chamber.

5.2.5 Preventive maintenance of the stability chamber shall be carried out once every three (3) months by a qualified service engineer, and records shall be maintained as per Annexure.

5.2.6 Any abnormalities identified during preventive maintenance shall be rectified immediately.

5.2.7 The water level of both the reservoir tank and main tank shall be checked at the start and end of each shift.

5.2.8 All maintenance activities shall be documented in the Stability Chamber Maintenance Record as per Annexure.

Also read – Analytical Instrument Qualification For HPLC System

5.3 Calibration

5.3.1 Calibration of the stability chamber shall be performed by an external qualified agency at least once in a year.

5.3.2 Calibration results and records shall be documented in the Stability Chamber Calibration Record as per the respective annexure.

6.0 List of Annexures

 

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