COLD STORAGE MANAGEMENT – STANDARD OPERATING

PROCEDURE

1.0 PURPOSE

The purpose of this SOP is to describe how to validate cold storage facilities.

2.0 SCOPE

The SOP covers the validation of cold storages viz. refrigerator / deep freezer / walk-in cold
storage rooms and walk-in freezers.

3.0 RESPONSIBILITIES

Engineering personnel and Quality Assurance personnel.

4.0 MATERIAL AND EQUIPMENT

4.1 Calibrated glass thermometer with indicating fluid as Red Alcohol.

4.2 100 ml vials filled with 50 ml glyceral (50%) with cotton at the base.

1. 100ml vials – 5 nos.

2. Cal. Thermometer – 5 nos.
3. Gly Ceral (50%) – 250ml
4. Cotton – 50gm
5. Water

5.0 PROCEDURE

5.1 Five vials (100ml each) are filled with 50 ml glyceral (50%) and small piece of cotton is
placed at the bottom of the vial to avoid breakage of thermometer.

5.2 Calibrated thermometer (no. ) is placed in the above vial.

5.3 Each such vial is placed at predefined four corners and at the centre.

5.4 The temperature is as shown in recorded manually after every 30 minutes interval for 6
hours.
6.0 FREQUENCY

The activity should be carried out once in 6 months.

7.0 PRECAUTION & SAFETY

7.1 The refrigerator / freezer / walk-in refrigerator / walk-in freezer should be opened only
for monitoring temperature.

7.2 If the vial that contains thermometer is broken then it should be cleaned using paper
towel and waters. Proper personal protection such as disposable gloves should be
employed.

R. A. (QC) Sr. Sc. (Prod.) Sub Eng. Director (I/c)