Risk Assessment
Risk Analysis Study Protocol for Rinse or Swab Analysis Study Protocol for Rinse or Swab Discontinuation
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+ Free ShippingRisk Analysis Study Protocol for Rinse or Swab Analysis Study Protocol for Rinse or Swab Discontinuation
- In G-block cleaning validation is done on the basis of Dose Criteria.
- In tablet section Alprazolam is the worst case while in Hardgel Capsule section Domperidone is the worst case.
- Type B cleaning is done after every batch change over.
- Both API’s are practically insoluble in water, hence cleaning agent Extran MA02 used for Type B cleaning.
- Extran MA02 is water soluble hence during type B cleaning all equipments are finally washed with Purified water.
- After cleaning rinse/swab were sent for residue scanning (no residue should observed).
- Any residue transferred in upcoming batches will leads to contamination. There is the more chance of contamination in water insoluble API’s.
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