Production of Active Pharmaceutical Ingredients: A process that requiring control and precision
Active Pharmaceutical Ingredients production essentially needs an optimum process that is in coordination with the system
System needs to be flexible and at the same time contamination from other Active Pharmaceutical Ingredientsmust be avoided. Optimization of process is a key in dealing with those challenges. The goals of any process of synthesizing API are:-
- reduce costs and processing time
- prevention of contamination of the active ingredients
- removal of by-products
- improve employee safety
Following are the steps involved in production of Active Pharmaceutical Ingredients at large scale:-
- Storage of raw materials and chemicals in controlled and sterile environment
- Laboratory must be optimally controlled to ensure safety of the workers and at the same time have optimum process efficiency and reduced effort in ensuring compliance with requirements. Importance of maintain the consistency in quality of Active Pharmaceutical Ingredientsin large scale production must be stressed
- Equipment must be sterilized properly. They should be cleaned and rinsed properly. A combination of physical measurements and biological indicators should be used to validate the sterilization process.
- Raw materials and catalysts required must be prepared efficiently before use. Mixture must be prepared in the exact proportions and all the supply must be documented to have a steady supply process
- In the heart of the process, the reactor must offer flexibility and at the same time maintain optimum speed in an automated system. Process equipment should be planned in such a way so as the generation of particulate matter is minimized
- Purification and separation is a crucial step. Filtration, Crystallization, sifting, drying, or centrifuging or combination of above processes are generally used in purification of Active Pharmaceutical Ingredients. This structure also needs to be eco-friendly and energy efficient at the same time
- The final step i.e. conditioning is done to achieve desired size and shape of Active Pharmaceutical Ingredients so that they can be mixed and packaged easily
So production of Active Pharmaceutical Ingredients is a precise and difficult process and extra care is needed to achieve desirable results.