Problem & answerC-08
Granulation End Point Missed
Also covers: Over- or under-granulation
Likely causes
- Incorrect binder quantity or addition rate
- Impeller or chopper speed incorrect
- Mixing time incorrect
- Powder properties changed
- Environmental conditions
How to fix it
- 1Stop and assess the batch.
- 2Evaluate granule quality (size, strength, moisture).
- 3Investigate root cause.
- 4Determine product impact with QA.
- 5Implement corrective action and document all decisions.
Technical note
Under-granulation gives weak granules, fines, poor flow and dust. Over-granulation gives dense, oversized granules, poor flow and slow dissolution. Too little moisture prevents granule formation; too much gives sticky, oversized granules and long drying.It is fixed when
Granules strong, uniform, free-flowing and at the correct moisture.
Stop it coming back
- Define and validate end-point criteria; monitor in real time.
Did this solve the problem?