During process validation of powder for oral suspension, blend uniformity test has been considered to validate the blending process. In filling sealing stage, which test need to be considered ? Is it enough to consider weight variation & leak test from start, middle, end of filling ? Or it is required to test the assay parameter from ten bottles individually from start/middle/end sample. Pls. suggest
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The following tests should be considered for the ‘Filling & sealing’ operation of the process validation of powder for oral suspension,
- Cleaning operation of bottles and caps is not considered in these checks.
- Weight variation of powder blend in the filled bottles (beginning, middle, and end of filling operation and after every break, such as lunch break, Breakdown maintenance, Machine setting, Shift changeover, etc.).
- Sealing quality (through torque tester device)
- Leak test (Vacuum test)
- Optical test of filled bottles for any visual defects such as cracked bottles, black or other foreign particles and poor-quality pilfer-proof caps
- Defects in child-resistant caps (if used)
- Appearance, pH, and viscosity of reconstituted suspension (as per finished product specification)
- Assay of active ingredient(s) from individual bottles during filling at the beginning, middle, and end of the filling operation.
- Perform rejection analysis of filled and sealed bottles such
The number of filled bottles rejected due to weight variation, physical defects, poor cap quality, failure of leak test, optical defects, etc. - Any high % of rejections beyond limits should be investigated to determine the root cause(s) and take appropriate CAPA.
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