OBJECTIVE:To describe the calibration procedure for distribution of temperature within the chamber of Refrigerator.
SCOPE: his SOP shall be applicable for Calibration of Refrigerator at Pharmaceutical Industries.
RESPONSIBILITY :
Quality Control Executive/Officer.
ACCOUNTABILITY
Head Quality Control
PROCEDURE :
Operate the refrigerator as per Standard Procedure.
Insert the probe of Minimum & Maximum digital temperature thermometer at redecided location.Keeping the thermometer outside the refrigerator.
Close the door properly. Wait for 15 min. to stabilize the temperature inside.
Record the temperature in calibration format.
Repeat the above step for different selected locations.
The temperature distribution must be within the range of 2°c to 8°c inside the chamber of Refrigerator.
Repeat above step for different locations inside the deep freezer.
The temperature should be in the range -25ºC to -10°C inside the deep freezer and distribution within chamber should be ± 2°C inside the deep freezer.
Fill the details of the calibration status in the label pasted on the Instrument /Apparatus.
Report any discrepancy observed during calibration to Quality Control Manager and notify the defect to
engineering department or Service Engineer of the instrument. Affix an Under Maintenance label on the
instrument.
| Sr.No | PARAMETER | STANDARD | ACCEPTANCE CRITERIA | FREQUENCY | REFERENCE |
| 1
|
Temperature Distribution in the chamber of refrigerator. | Calibrated RTD Probe/Thermometer | 2 – 8 °C
|
Quarterly | In house
|
| 2
|
Temperature Distribution
in the deep freezer.
|
Calibrated RTD Probe/ Thermometer | ± 2°C
|
Quarterly | In house
|