Solving tableting problems by optimizing the granulation process
Situation at first contact
A global pharmaceutical company focused on semi-solid and liquid products contacted us, because one of their few solid products showed increasing OOS events. To counteract this trend, and because the contract manufacturer itself had no breakthrough ideas, the company asked us to investigate the tableting process.
Our Approach
Step 1 – Requesting and analyzing documents
A review of the documents showed that the tableting process was unremarkable. However, no other clear reason was immediately recognizable, but it was suspected, that the wet granulation might cause the problems. We therefore agreed to inspect the entire production and carry out a root cause analysis.
Step 2 – Root cause analysis in production
Several crucial observations were made during a 2-day production monitoring program. The appearance of the wet granulate was not ideal and showed a wide distribution in its properties resulting in OOS events in the tablets. This variation had begun gradually and could be linked to the purchase of a new HSM several years before.
Step 3 – Production support
A number of production trials were carried out to optimize the parameter of the wet granulation and to minimize the variations of the granulate. The tableting properties of the granulate were also always analyzed to get a direct feedback.
Results
By optimizing the granulation process, mainly by adapting the wet granulation parameter to the new equipment, a stable process could be established. The variations in the granule properties were minimized and the OOS events in the tablets recued.
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