White Paper
Predicting The In-Process Behavior Of Powders
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•White Paper: Predicting The In-Process Behavior Of Powders
By Tim Freeman, Freeman Technology
Pharmaceutical products are generally manufactured in batches, using a series of sequential processing steps. The output from each unit operation is assessed before further processing. Batches failing intermediate, or indeed final, quality testing incur lost revenue in the form of wasted feed materials and inefficient equipment utilization. Estimates suggest that across the industry rejected batches, re-work and investigations into the cause of a problem consume as much as 25% of drug company revenues.
The root cause of these problems is usually a lack of compatibility between the material and the process plant. Consistent and efficient operation requires the powder properties to be those which suit the processing step, whether this is storage in a hopper or flow through a tableting press. Of course the compatibility challenge is compounded by the inherent complexity of powders, and in particular the impact of air on flow properties. Air content can be so reduced that the powder becomes a solid, while the same powder, if very aerated, may behave as a fluid. Fortunately not all batch production is problematic and examples of consistent and efficient production occur from which much may be learned.
One route to improved process economics is to identify as quickly as possible any batch that is not going to behave in the required manner. If the material is an alternative feed from a new supplier then this should happen before it is ever introduced into the plant. With in-process streams, failures must be detected immediately after the problematic step and before the next unit operation. The key in both cases is to develop specifications that accurately reflect process behavior.
Click Here To Download:•White Paper: Predicting The In-Process Behavior Of Powders
