Primary Root Causes of MUPS Content Uniformity Failure | Tablet & Sterilization Machines - Pharmaceutical Manufacturing Equipment | Yenchen

Primary Root Causes of MUPS Content Uniformity Failure | Yenchen Machinery Co., Ltd. has been specializing in manufacturing Pharmaceutical Machine for 60 years.

Primary Root Causes of MUPS Content Uniformity Failure

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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Primary Root Causes of MUPS Content Uniformity Failure | Tablet & Sterilization Machines - Pharmaceutical Manufacturing Equipment | Yenchen

Located in Taiwan since 1967, YENCHEN MACHINERY CO., LTD. has been a pharmaceutical manufacturing equipment supplier in pharmaceutical industry. Their main manufacturing and processing equipment include, hot air sterilizers, extrusion machines, tablet coating and compression machines, pellet making machines and oral solid dosage manufacturing equipment, which are sold to over 70 countries meeting international standards.

Yenchen was established in 1967, our products and services are widely used in the pharmaceutical, food, biotechnology, chemical, and cosmetic fields, which include solid dosage line, pellet machine production line, syrup line, injection line, ointment line, extraction & concentration turnkey equipments.

Yenchen has been offering customers high-quality pharmaceutical manufacturing equipment since 1967, both with advanced technology and 57 years of experience, Yenchen ensures each customer's demands are met.