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PHARMACEUTICAL INDUSTRY :
Process Manufacturing Improvement |
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Client: |
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A major generic pharmaceutical company |
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Problem: |
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In the months following launch a downward trend was identified in a key dissolution specification. As a result, product was coming dangerously close to the lower specification limits and occasionally failing. Despite efforts to stabilize the downward movement, the trend continued. The client wanted to shift the dissolution curve away from the lower acceptance limit. Meanwhile, a performance test was being utilized to identify acceptable controlled-release raw material with aim of determining acceptable specifications to provide to the vendor. |
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Approach: |
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The client asked Tunnell to investigate and resolve the problem. A cross-functional approach was employed using a joint client/Tunnell project team that included a project manager, a formulation scientist, process engineers, statisticians, and data analysts. Batch record data was entered into a comprehensive database for more than 42 batches of product and 44 batches of raw material representing good and bad process performance. Focused interviews were conducted with key personnel from relevant levels and functions. A detailed review of previous investigations and documents was completed, and detailed process observations were made. Due to the unique process for this product, a "reverse engineering" study was designed and executed. Statistical analysis of raw materials identified a critical success specification. Utilizing the data gleaned from these studies, a designed experiment was conducted that successfully identified process conditions which would allow shifting the dissolution curve away from the lower specification limit while assuring raw materials performed as intended. |
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Results: |
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Outcomes of this effort included the following:
Key process variables were identified through "reverse engineering."
Data-driven analysis, along with iterative technical insight, was employed to identify a key raw material
specification.
A design of experiments (DoE) was executed and process changes were identified to return the process
dissolution curve to an acceptable range.
Work was completed within the required time frame and budget.
The client's assurance of consistent supply to the market was improved.
Tunnell's problem-solving methods were transferred to key client personnel through the joint team approach.
Expected savings from a reduction in discarded batches are estimated at $800,000 per year.
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