SOP for Calibration of Colony Counter : Pharmaceutical Guidelines

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SOP for Calibration of Colony Counter

Standard operating procedure of evaluation of performance of digital colony counter.

1.0 OBJECTIVE

To describe the procedure to calibration of colony counter.

2.0 SCOPE

This SOP is applicable to calibration of colony counter.

3.0 RESPONSIBILITY

Microbiologist - Quality Control

4.0 ACCOUNTABILITY

Manager – Quality Control

5.0 PROCEDURE

5.1 Write counting up to 100 on a white paper.
5.2 Operate the equipment as per SOP of operation of colony counter.
5.3 Press the surface of counter screen 100 times with pointer/marker and then check the number displayed on the screen.
5.4 Reset to 000 and again press the manual button 100 times and check the number displayed on the screen. In both cases, the number displayed on the screen is also 100.
5.5 Repeat this procedure for 5 times to ensure that the calibration procedure will give a consistent result.
5.6 If the equipment does not produce required calibration results or its response is poor then it should be labeled “Out of Calibration” and should be repaired.
5.7 After completion of calibration procedure record in the calibration record of colony counter Annexure I.
5.8 Frequency: The calibration frequency of digital colony counter is once in a month.

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure

ANNEXURE- I 
CALIBRATION RECORD OF COLONY COUNTER
Asset ID  No.
:

Ref.  SOP No.
:

Make
:

Model No.
:

Effective Date         :                                                                       
Location                  :
Date of Calibration  :
Next Due Date         :
Surface pressed
Number displayed on screen
Manual button pressed
Number displayed on screen
100 times

100 times

100 times

100 times

100 times

100 times

100 times

100 times

100 times

100 times

Observation: The Colony Counter is working satisfactorily /not working satisfactorily, requires/ does not require maintenance.

Calibrated By:                                                                                      Reviewed By:
Date:                                                                                                    Date:
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