Operation and Cleaning of Refrigerator in QC Laboratory

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OPERATION AND CLEANING OF REFRIGERATOR IN QC LABORATORY

1.0 PURPOSE

To establish standardized procedure for operation, monitoring, cleaning and maintenance of refrigerator used in Quality Control Laboratory for storage of reference standards, working standards, reagents and microbial cultures at temperature 2-8°C.

2.0 SCOPE

This SOP is applicable to Refrigerator (Make: ________ Model: ________ Sr. No: ________) located in Quality Control Laboratory used for storage of temperature sensitive materials requiring 2-8°C storage condition.

3.0 RESPONSIBILITY

Designation Responsibility
QC Analyst Daily monitoring, operation & cleaning
QC Executive Review of records & monitoring data
Head QC Compliance & training

4.0 PROCEDURE

4.1 OPERATION

  1. Ensure Refrigerator is connected to uninterrupted power supply.
  2. Switch ON the main power supply of Refrigerator.
  3. Set the thermostat at NORMAL or 4°C.
  4. Allow the Refrigerator to attain the temperature and stabilize.
  5. Do not overload the Refrigerator. Maintain air circulation space.
  6. All the material shall be labeled properly with name, date of receipt & use by date.
  7. Arrange the material shelf wise as per their use by date (FIFO).

4.2 TEMPERATURE MONITORING

NOTE: Record temperature twice daily (Morning 9:00 AM & Evening 5:00 PM)

  1. Record the temperature of Refrigerator in respective format daily twice.
  2. Alarm limits: 2°C to 8°C.
  3. In case of temperature excursion follow excursion procedure.

4.3 CLEANING

  1. Frequency: Once in a month or when required.
  2. Switch OFF and unplug the Refrigerator.
  3. Remove all the material & shift to backup refrigerator.
  4. Remove all the shelves & trays.
  5. Clean the interior with 70% IPA solution using lint free cloth.
  6. Clean the shelves & trays separately.
  7. Wipe with purified water & allow to dry completely.
  8. Fix back the shelves & trays.
  9. Switch ON the Refrigerator & allow to attain temp.
  10. Record the cleaning activity in respective format.

4.4 TEMPERATURE EXCURSION

  1. Inform to Section Head immediately.
  2. Shift the material to backup refrigerator if required.
  3. Investigate the cause of excursion.
  4. Fill deviation form & send to QA for approval.
  5. After temperature stabilization, material may be shifted back.

5.0 RECORDS

  • Refrigerator Temperature Monitoring Record
  • Cleaning Record of Refrigerator
  • Refrigerator Content Record
  • Temperature Excursion Investigation Record

6.0 REVISION HISTORY

Version Date Change Description



Prepared By
Name: _________________
Date: __________ 		Checked By
Name: _________________
Date: __________
Approved By
Name: _________________
Date: __________ 		QA Approved
Name: _________________
Date: __________

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