Article | REF: CHV4010 V1

Forming processes of pharmaceutical active principles in supercritical phase

Author: Elisabeth BADENS

Publication date: September 10, 2017, Review date: December 5, 2016

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5. Scale-up issues

There are currently in the world several hundred industrial units using SCF mainly dedicated to extraction, purification or fractionation. As supercritical extraction has been in existence for more than 30 years, we enjoy the benefit of practical feedback for the future development of formulation units. Like every industrial installation, a formulation unit must be highly reliable and of an acceptable cost. Production must take place in safe conditions, especially since active formulations are produced under pressure. The installation must be designed so that all contamination is avoided, not only during the phase of particle collection, but also in the event of leakage, emergency shut-down, or opening of a safety valve. All effluent must be collected and purified before release into the atmosphere. Production must comply with Good Manufacturing Practices (GMPs), particularly with regard...

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Scale-up issues