ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Each recipe step encompasses one or several functions. Operations stand for major treatment steps. An operation usually results into a chemical or physical transformation regarding the product. e.g., typical sequence of operations related to the production of PVC (Polyvinyl Chloride):

• prepare reactor: set vacuum for eliminating O2;

• load: fill with demineralized water and tension actives substances

• initiate reaction: mix monomer of vinyl chloride and catalyst

• heat (Tº set-point ranges 55ºC to 60ºC and maintain this set-point up to the pressure decrease

Publication Source: ISPE Baseline® Guide, Vol. 2: Oral Solid Dosage Forms (Second Edition)

Publication Date: 2009

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