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Monday, September 12, 2011

Incubator Standard Operating Procedure-Free Gpat Material From Pharmagupshup.in

SOP FOR OPERATION AND MAINTENANCE

1.0 OBJECTIVE
To ensure that the incubator performs satisfactorily and maintain accurate temperature for Microbial growth.

2.0 SCOPE

The SOP covers procedure for operation and calibration of incubator and is applicable to Quality Control Department formulation Units

3.0 RESPONSIBILITY

Microbiologist.

4.0 ACCOUNTABILITY

Department Head.

5.0 PROCEDURE

5.1 Ensure that the power supply to the incubator is switched ‘OFF’.
5.2 Dedust the incubator daily externally with a clean dry cloth.
5.3 Once a week remove adhered dust by wet mopping using detergent solution. Afterwards wipe the surface with a clean dry cloth to
      remove traces of detergent.
5.4 Once in a month clean the interior surfaces with 2.5 % savlon solution using a clean cloth.

6.0 OPERATING PROCEDURE
6.1 Ensure that the incubator is properly connected to the power supply.
6.2 Switch on the main .
6.3 Turn on the red colour power knob towards 0-1.
6.4 Turn on the cooling knob towards 0-1.
6.5 To set the incubator at 22°C , set the lower temperature 21 OC by pressing the ‘SET POINT -1’ and simultaneously adjust the
      temperature with the help of screw of SET and RST by screw driver.
6.6 .Set the higher temperature 23 OC by pressing the ‘SET POINT -2’ and simultaneously adjust the temperature with the help of screw of
       SET and RST by screw driver.
6.7 In the same manner the incubator can be set to 37°, 44° and 55°C whenever required by setting the lower temperature to 36°,43° and 54° C respectively and by setting the higher temperature to 38°,45° and 56° C respectively.
6.8 Record the temperature twice daily. i.e. in the morning and in the evening. The temperature should not differ ± 2° C from the set
     temperature.
7.0 Trouble shooting problems and remedial action :
7.1 The temperature display is not glowing. Check for power supply and proper electrical connections of instruments with power point.
7.2 Temperature is not even in the incubator. The air circulating fan may not be functioning. Check for it.
7.3 Report any discrepancy observed during operation or temperature monitoring to Q.C. Executive and notify the defect to Maintenance Department.

8.0 CALIBRATION

8.1 Set the incubator temperature to 22°C. Wait till the set temperature is reached.
8.2 Take a calibrated thermometer and dip it in a 500 ml beaker filled to 3/4 of the volume with Glycerol AR grade.
8.3 Keep the beaker inside, at the center of the incubator. close the incubator door. Allow the temperature to equilibrate for 30 minutes.
8.4 Observe the temperature shown by the thermometer. The temperature shown by the
display and by thermometer shall not differ by more than 0.5°C.
8.5 Record the temperature at two time intervals ( with a gap of 6 hours) in the temperature record.
8.6 By following the same procedure as above carry out calibration by setting the incubator temperature to 37°C, 44°C and 55°C.
8.7 Record any discrepancy observed during operation or during temperature monitoring to Quality Control Executive and notify the defect to technical assistant for rectification. Affix “BREAK DOWN” label on the instrument.

9.0 FREQUENCY OF CALIBRATION :

9.1 Once a month and after each maintenance job.
9.2 Record the calibration record in the format prescribed


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