Girish Malhotra , president of Epcot International , looks at a key issue for the APIs and related fine / specialty chemical industries
Net zero for APIs
Girish Malhotra , president of Epcot International , looks at a key issue for the APIs and related fine / specialty chemical industries
Achieving net zero is a major new target for the processes that produce fine and speciality chemicals and APIs . 1 The pharmaceutical industry is known for its high emissions per kilo . 2
It is possible to reduce or minimise solvent use for every chemical synthesis process via non-destructive creation , i . e . the commercialisation of alternative processing method for each product from the onset . 3 This significantly lowers the net zero number for each product from the onset . The learnings can be applied to existing products .
Implementing methods to achieve net zero requires an effort from the ‘ whole village ’ ( chemists and chemical engineers , marketing , financial analysts , supply chain professionals , quality control , regulators , maintenance and manufacturing personnel ). It is very likely that the effort will involve changes to how the chemistry is practised commercially . 4 - 7 The process will definitely involve the reconfiguration of manufacturing and process technology . If this is done correctly , the desired molecule ’ s quality and performance will not change .
Each company can develop its own pathways to solvent reduction . Based on my experience , the simplest way is to reduce this at every reaction step . It can be achieved by taking advantage of a combination of physical properties , e . g . melting point , boiling point and freezing point , solubility in different solvents , their interactions and chemical kinetics , all of which I refer to by the term ‘ sociochemicology ’. 8 - 9
It is critical that IP involving how processes are modified and practised should be internalised and protected at each company . This pathway will be a challenge as the companies will
Figure 1
NaNO2 Amine
HCl
Heat exchanger
Figure 1 have to internalise their processes and manufacturing methods .
It might also mean reliance on CDMOs might have to be minimised . Lack of experienced internal manpower and expertise might intervene . Some new learning about how the unit processes and unit operations are practised might be necessary and fine-tuning existing processes or methods might be needed . 10 - 11
It is very likely that no new chemistries will have to be developed for existing products . Rather , current commercial chemistries will have to be executed differently in smaller or alternative equipment . Thus , the interaction between , and the physical and chemical properties and reaction kinetics of , each chemical used and produced would have to be capitalised on in order to simplify the processes . 8 , 9
Process development chemists , engineers and members of the scale-up team will play critical roles in minimising implementation time . All three routes - the sociochemicology of chemicals , process-centric designs , and the creativity and imagination of the ‘ whole village ’ - can be used to get to net zero . Every chemist and chemical engineer is familiar with the first two ; the third is individual traits and depends on collective experience .
Figure 1 - Back mix diazotisation reaction
Product
Sociochemicology of chemicals
Sociochemicology encompasses the physical and chemical properties of each chemical and how they interact with each other . The behaviour of chemicals and equipment used in the process influence manufacturing methods and their execution . Each property needs to be exploited differently to create and simplify processes . This has value for every process design .
The API and fine and speciality chemical industries are living with the tradition of using larger-sized equipment to make its end products . This is in place and it does the job . However , round-bottomed flasks and associated laboratory equipment do not allow us to exploit the physical and chemical properties of the chemicals .
Our intention in the lab is to prove the feasibility of the reaction chemistry . A laboratory cannot experiment with and demonstrate the interaction of physical and chemical properties . It may be able to show feasibility but it is up to the chemist and the chemical engineer how to use them and simplify the processes .
Generally , a process engineer takes the information developed in the lab , proves its feasibility in a pilot plant and designs a commercial process in a large using appropriate reactor ( s ).
24 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981