Friday, 5 July 2019

Performance Qualification of Colony Counter


Performing the Performance Qualification.
Test the performance of the Colony Counter as per the Check List and record these in the Performance Qualification Report. The frequency of recording results has been decided based on the results of the Operation Qualification. The test methodology is defined in the check list.
The Colony Counter shall be handed over to Quality Control only after successful completion of Performance Qualification. 
Record all observations and deviations in the report. In case of deviation prepare a deviation report with justification and get it approved by Head Quality assurance, Head Quality Control.

Check list for Performance Qualification

EQUIPMENT / SYSTEM: COLONY COUNTER

Test  ( S) Required
Test Description
Acceptance Criteria
Results
Checked by
To check whether the display shows the initially a zero reading.
Connect the plug of Main A/C supply or power supply to the main electrical socket and switch on the main and observe the display.
Display should show the zero reading.


To count the number of colonies on the plates.
Fix the Lens at the suitable distance on the stand. Mark the colonies on the plate by using a sensor having a ball point pen or by pressing the Manual button. After counting all the colony, observe the display number.

It should show the correct reading to that counted by a marking pen.


To reset the count to zero.
After counting a plate, press the reset button to get a zero reading on the screen for counting another plate.
The display should show the zero reading.






Rahul Kashyap is the executive in a Leading Pharma Company, he author in-depth guide that teach pharma industry owner and workers way to follow, manage and grow the quality work in this Field.

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