API manufacturing and environmental sustainability


EPCOT International, Pepper Pike, OH, USA


Physical properties of chemicals are their unique hallmark. They are used in various unit operations to create simple and excellent chemical processes. They have been used for the last 100+ years to produce different fine/specialty chemicals that have improved our health and life style. Large amount of solvents have allowed use of available equipment to produce different fine/specialty chemicals. Even though most of the solvents are recovered and recycled, they still leave a large environmental footprint. For pharmaceutical active ingredients the foot print is the highest. Creative and thoughtful use of physical properties and unit operations can lead to significant lowering of emissions i.e. towards “Net Zero”. Out the box effort is needed and is reviewed in the book (2).

Pharmaceutical industry’s evolution and history are fascinating (1, 2). Volumes can be written on how the industry and each company has shaped itself. Their evolution is a story. Discussion here is not about the companies but about the development of small molecule active pharmaceutical ingredients (API) (3), their manufacturing methods and environmental impact and how it can be minimized.


For ages and still, many vegetation plants and their extracts were and are used to cure many diseases. Genesis of the current pharmaceutical industry took place when the chemists of the early part of the last century working at dyes and colorant companies in Europe were able to synthesize the disease curing chemicals of the plants extracts. They also started to recognize the disease curing values of different fine/specialty chemicals.


Chemical synthesis processes for the small molecule APIs are no different from the synthesis of fine/specialty chemicals and dyes/colorants. Equipment used (reactors, pumps, agitated tanks that were available in dye/chemical plants) are easily adopted and used to produce the needed APIs. Unit processes and unit oper ...