APIs (Active Pharmaceutical Ingredients) are the active ingredients in medicinal products

PDF: Eaton API Manufacturing Chemical Synthesis Application Brief EN

APIs or bulk pharmaceutical substances are manufactured using chemical and biotechnological processes, the latter being further differentiated into fermentation and extraction processes. Fermentation uses biological processes to produce active ingredients on an industrial scale with the help of microorganisms or cells. During the extraction process, the active ingredient is isolated or obtained from natural resources. After either chemical synthesis or biotechnological manufacturing or extraction, the active ingredient then undergoes various separation and purification steps until it can be presented in its final dosage form as a medicinal product. For chemical synthesis, Eaton offers a broad range of products for various filtration tasks in the individual process steps

The core component of chemical synthesis is the chemical reactor, which is followed by other additional steps, such as separation, purification, crystallization, drying and filling. Filtration is used to perform important separation and purification tasks during the manufacturing of APIs, such as: • Removal of catalysts and reaction by-products (e.g. particulates, molecular impurities) immediately after synthesis • Removal of unwanted discolorations or impurities during purification • Extraction of products and active ingredients after crystallization • Protection of plant components • Media filtration High standards and cGMP (current Good Manufacturing Practice) requirements must be observed to ensure quality and purity. For this reason, medicinal products and their active ingredients undergo a strictly regulated development process. From laboratory research to clinical development, scale-up/pilot manufacturing and process  validation, these steps ensure reproducible results.

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