API Production: Overview of the production of Active Pharmaceutical Ingredients.

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There is a variety of processes involved during production of the APIS that should be optimally coordinated ensuring flexibility while preventing cross-contamination at all cost. Processintegration from raw materials to the respective production reduces resourcewastages by reducing costs and processing time.

API production involves:

  • Ascertainment of correct raw materials.

These are the foundation of successful API production. The incoming goods department must be properly managed, adequately protected and properly documented. This leads to efficient commodity flows, transparency and improved safety.

  • Optimal laboratory control.

Due to the need to maintain consistent production of quality APIs,there is need to ensue safeenvironmental conditions. This is done by offering proven access control, building automation and management of possible hazards. Totally Integrated Automation ultimately enables the integration of the laboratory with all the existing control system in the AIP production.

  • Preparation foundation of successful production.

First class preparation means an efficient API production process. This starts at the incoming goods department by checking the raw materials to verify correct weights, ingredients and quality all through to the entire material flow i.e. from the raw material o the finished product.

  • Reaction from the process to the AIP produced.

During automation, these reactions need maximum flexibility at all stages of API production so as to ensure high quality products.

  • Separation and purification at each stage.

This may be throughfiltration, crystallization, centrifuging among others. Whichever process is used, quality API requirements set by the regulatory agencies ought to be met. All this enables increased productivity.

  • Conditioning of the perfect API production finished.

API production process optimization demands continue to grow leading to its automation. Appropriate materials properties such as size, bulk densities, flow properties as well as proper packaging for the next processes must be consistent and flexible enough from the first to the last batch.

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