Performance qualification (PQ) of a tablet coating machine is a critical step in pharmaceutical manufacturing to ensure consistent product quality. It involves demonstrating that the machine operates within established parameters and consistently produces tablets meeting predetermined quality attributes
PQ typically includes evaluating factors like coating uniformity, thickness, and drug content. It also verifies the machine’s ability to maintain these parameters across different batches and operating conditions. Successful PQ provides documented evidence that the coating process is robust and reliable, ensuring the safety and efficacy of the final product.
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Test Parameters for PQ
Inlet Air Temperature
Inlet Airflow
Bed Temperature
Outlet Air Temperature
Atomization Air Pressure
Gun to bed distance
Drum Speed (Pan Speed)
DP Drum (Pan DP)
Spray Pump RPM
Description of Tablet
% Weight Gain
Thickness of Coated tablet
Length of Coated Tablet
Width of Coated Tablet
Individual Weight Variation of Coated Tablet.
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Annexure 2
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Annexure 3
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Annexure 4
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Annexure 6
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Annexure 6
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Annexure 6
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Annexure 6
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Annexure 6
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