
Primary Root Causes of MUPS Content Uniformity Failure
Source : Yenchen Technical Process Consultant, Dr. Fred Rowley
A. Size of the beads
- Inability to establish reliable results:
- Supplier issues with particle size distribution
- Differences in measurement between supplier and user
- Misunderstanding of criticality of bead size - Beads and Size Segregation:
- Variations in individual particle mobility with size typically lead to segregation in a bed of particles subjected vibration or flow.
B. Differences in key raw materials
- Excipient vendors:
- differences within the established specifications - Storage and delayed use of key excipients
C. Tablet press Set up:
- Wrong press settings
- Press personnel unaware of proper settings.
- Proper settings not on batch record
- Improper settings given by R & D to Manufacturing.
- Different presses during scale up, differences between R & D and Manufacturing.
D. Excessive press speed
- The greater the press speed the more potential bead shifting. This is more of a concern with capsule shaped tablets.
- Bead circulation becomes more of an issue as press speed increases.
If you have any technical questions, please contact with Grace Chiang Email:grace.chiang@yenchen.com.tw
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