Cleaning and Operation of Refrigerator

In this post Standard Operating Procedure Cleaning and Operation of Refrigerator in Pharmaceuticals is describe.

1.0 OBJECTIVE:

To lay down a procedure for Operation of Refrigerator in Production Department.

2.0 SCOPE:

This procedure is applicable for Operation of Refrigerator in Liquid Oral Department.

3.0 RESPONSIBILITY:

Officer/ Executive Production department- Responsible for handling & operation of Refrigerator.

Head Production Department- Shall ensure compliance of the SOP.

4.0 DEFINITION(S):

5.0 PROCEDURE:

5.1.1 Collect the dispensed Raw material from store to kept in the refrigerator which require storage condition 2°C to 8°C

5.1.2 Record the time of Raw material kept in the Refrigerator after dispensing and out time from the refrigerator to manufacturing in Equipment Usage and Cleaning Log sheet as per Reference SOP.

5.1.3 Production officer shall collect the key of Refrigerator from the area incharge and submit the same after completion of activity.

5.1.4 Ensure that no material being kept in the freezer.

5.1.5 Ensure that the sensor (1 No.) is kept inside the Refrigerator on top left corner.

5.1.6 Ensure that the instrument is calibrated

5.1.7 Check the Temperature reading of the Refrigerator and record in the Annexure I.

5.2 Frequency: Twice in a shift when material is kept in Refrigerator.

5.3 Limit of Temperature: 2°C to 8°C

5.4 If the temperature of the Refrigerator is out of Limit then kept the material in store refrigerator and inform to Engineering department for corrective action.

5.5 Cleaning of Refrigerator.

5.5.1 After completion of activity clean and dry the inner side of the Refrigerator with dry lint free cloth and outer side with dry lint free cloth.

6.0 ABBREVIATIONS:

SOP : Standard Operating Procedure

° C : Degree Celsius

7.0 REFERENCE(S):

SOP: Equipment usage and Cleaning log sheet.

8.0 ANNEXURE(S):

Annexure I: Temperature Monitoring of Refrigerator.

9.0 DISTRIBUTION:

9.1 Master Copy: Quality Assurance

9.2 Controlled Copy (s): Production Department, Quality Assurance