Modular Turnkey Concept for Pharmaceutical Sterile Formulation
Sterile parental drugs are produced or formulated in GMP critical batch processes. These automated process installations are submitted to a lot of regulations applying to the pharmaceutical industry. The formulation installations have moved away from being just utilities extensions and have become speciality installations requiring a high degree of technical skills but also knowledge about regulations and qualification/validation strategies. As a result of this, specialised suppliers offer a turnkey approach for concept design, detailed engineering, realisation and qualification of these installations. Nowadays, there is a move towards modular skid concepts, allowing prefabrication and pre-qualification.
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Author: Geert Roggeman, WBF
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