Friday, 5 July 2019

Performance Qualification of Volumetric Air Sampler


Performing the Performance Qualification

Test the performance of the VOLUMETRIC AIR SAMPLER 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 VOLUMETRIC AIR SAMPLER 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: VOLUMETRIC AIR SAMPLER


Test ( S) Required

Test Description

Acceptance Criteria

Results

Checked by
Flow rate
 Follow the procedure as      
 described in operation
± 1.0 %


To Switch ON the instrument
Push the ON/OFF button. Press the START/DELAY Button quickly twice.
The air sampling should be started and the screen will shows the amount of air sampling remains.


To Adjust the volume to be processed.
 Push the LITRES button once. Press the Liters button once to access other preset volumes. Select the preset volume that is just below the volume to be process. Then hold the button down until the tester display indicates the desired sampling volume.

The screen display should show 1000 litters of setting on it.



To Adjust the Timer.

Hold down the START/DELAY button. Press again START/DELAY button again. Time can be changed by increments of five minutes. Press the ON/OFF button to stop.


LCD display flashes.



Test ( S) Required

Test Description

Acceptance Criteria

Results

Checked by

To change the battery.
Switch of the tester. Remove the screw under the tester. Remove the used batteries. Replace the new battery. Tighten the two screws. Charge the new batteries until the battery icon disappears from the LCD display.
The battery with Model R14 should be well positioned by checking its polarity.


To charge the batteries.
Plug the charger in to the tester, The LCD display show “AC”. Charge it until the battery icon disappears from the LCD display.
When the Battery icon starts flash on the LCD display the battery should be charged. The battery icon remains visible until the complete recharge.


To Run the tester
Unlock & remove micro perforated sieve from tester. Position the wings of cassette into the recessed area of tester head. Remove the Lid. Lock the sieve in position. Press the ON/OFF button. When the display indicates EOC, unlock the sieve and put the lid on cassette.
The screen display should start count down of the sample volume from 1000 liters to EOC by a fraction of 25 liters.





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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