Specialists in Sterile Products and Processes

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Process Development

Solubilization of the drug and other required excipients in case of solution products, particles size reduction, in-situ salt formation, terminal sterilization and or aseptic processing are some of the unit processes are undertaken at the laboratory scale. Once all the key and critical process parameters are identified, the process is finalized keeping in mind commercial process at much larger scale. Interactions of formulation components as well as compatibility with packaging components are tested and based upon this basic understanding, a rational process strategy is developed.