Problem & answerB-04
Over-Lubrication
Likely causes
- Lubricant (e.g. magnesium stearate) blended too long
- Lubricant added too early
- Lubricant quantity too high
How to fix it
- 1Notify the supervisor and QA.
- 2Check the lubricant addition time and quantity in the BMR.
- 3QA assesses impact on downstream filling or compression and dissolution.
Technical note
Magnesium stearate is hydrophobic. Over-mixing coats particles, which can slow dissolution and reduce tablet hardness. Keep the lubrication step short and timed.It is fixed when
Lubrication step time and quantity match the BMR.
Stop it coming back
- Add lubricant last and time the lubrication step separately.
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