Mettler-Toledo International Inc.

General product information

In the formulation of a pharmaceutical product, numerous unit operations (dry milling, granulation, fluid bed drying, compaction, etc.) might be employed to manufacture the final deliverable form. But because each unit operation has its own sources of variability and is also influenced by variabilities associated with the operations preceding it, multiple independent variables must be optimized in order to achieve the desired final product quality in the process.

Ensuring product quality traditionally relied on offline analytical tests -- either of the final product or of samples taken after each unit operation. While such data can be used retrospectively to confirm whether or not a unit operation performed acceptably, it is not sufficiently timely to influence the setup of downstream operations, nor can it be used to fully explain the interdependency of variables between unit operations.

The use of in situ real-time monitoring techniques allows continuous monitoring of unit operations without the need for offline sampling. Information can be used at the process development stage to understand and optimize a new process, or during routine manufacture for control purposes.

More Information
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