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PROCEDURE FOR CALIBRATION OF REFRIGERATOR

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

 

 

 

 

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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