Friday, 5 July 2019

Performance Qualification of Bacteriological Incubator


Performing the Performance Qualification.
Test the performance of the Bacteriological Incubator 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 BACTERIOLOGICAL INCUBATOR 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 : BACTERIOLOGICAL INCUBATOR


Test  ( S) Required

Test Description

Acceptance Criteria

Results

Checked by
To check whether the display shows the cabinet temperature or not when turned on.
Connect the plug of BACTERIOLOGICAL INCUBATOR into the main electrical socket and switch on the main and observe the display, it shows the temperature of the cabinet.
It should show the temperature of the cabinet  when turned on


To check whether the panel is showing the exact temperature of the cabinet or not.
 Keep std thermometer inside the cabinet put on the main switch .Observe the temperature of both shown by thermometer and panel.
Both readings shown by thermometer and panel should be same.


To set the required temperature
Initially put on the instrument, Press button provided on the panel to adjust the required temperature.
After some time the required temperature which is set should be shown by panel and also by thermometer is kept inside.




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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