• Is the blend uniformity (BU) data within specification?
• Has the blend been properly sampled (stratified sampling procedure, properly selected thief, etc.)?
• Is the BU variation due to within or between location variation?
• How is the blend transferred to the press/encapsulator/dosing machine?
• Is an Intermediate Bulk Container (IBC) used in the process?
• Is a transfer chute used in the process?
• Is the content uniformity (CU) within specification?
• Have the dosage units been properly sampled (stratified sampling procedure)?
• Is the CU variation due to within or between location variation?

We have worked on over a hundred projects diagnosing and solving BU and CU problems.   We can assist you in determining the root cause of a problem and providing corrective actions using a typical project approach by offering such key engineering services as materials characterization and consulting.

It is often challenging for formulators and process engineers to determine if a target production rate (tableting/encapsulation rate) can be achieved during the early stages of development.   Production rate limitations can arise as a result of two-phase (powder:air) flow effects.
 
J&J can answer these concerns during development by conducting bench-scale materials characterization tests on a small sample of powder, and use this information in a flow rate analysis of an existing or proposed feed system at full-scale.  By conducting such an analysis we can determine:

• What maximum feed rate can be obtained
• What changes to the material properties (e.g., the particle size distribution) are beneficial
• What modifications to the feed system (chute, press hopper, etc.) are beneficial

We have posted a new web page detailing how this feed rate analysis is conducted.  This valuable information may help you prevent feed rate problems before they occur by addressing concerns at the early stage of development or addressing an existing problem.