Speciality Chemicals Magazine MAR / APR 2025 | Page 28

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PHARMACEUTICALS
from the vendors who want to control how their equipment is used .
The lack of this information has become an obstacle and can interfere in ‘ what if ’ analysis to select the optimum equipment for the minimum solvent use . 19 The lack of equipment and physical properties information can likewise be a brake on innovation in manufacturing technology .
Modular process designs can be very valuable alternative process design to current practices . 4 - 6 , 13 They can reduce capital investment , improve profitability and add process flexibility to meet fluctuating product demands .
The use of such configurations might be considered cumbersome , as the chemical and pharmaceutical industries are not attuned to out-ofthe-box thinking . However , we need to understand their value in reducing solvent use for every chemical synthesis process . They can be a competitive advantage and improve speed to market .

Chloroaniline chloroaniline

The non-destructive creativity pathway
Established practice from the laboratory to commercial scale where excess solvent is used arises from the need to fit the process into existing equipment . 18 To achieve net zero every bit of ‘ nondestructive creativity ’ and everyone ’ s understanding of chemistry and chemical engineering will be needed and may have to be tested . Outsiders can help but the initiative has to come from within .
Chemists and chemical engineers will have to think out of the box . They have the creativity and imagination to excel . There will be initial apprehension , but when conventional unit processes and unit operations are applied , they will see the benefits . They could , going forward , become addicts .
The answer to whether API manufacturing and fine and speciality chemicals are ready for net zero , is ‘ It depends ’. Yes , there will be financial
and business model implications as many APIs do not have sufficient product volume and can only be produced on a campaign basis . Some business models might have to be reconfigured and there could be resistance .
The upside will be significantly lower idle time for equipment , which has marred API manufacturing and is one cause of high emissions . 20 With alternative processes , companies could respond quickly to drug shortages . Again , though , all of the innovations will have to come from within the company .
Since there is no mandate to achieve net zero for existing products , each company will have to justify its effort . There are financial implications . Significant amounts must be spent with unknown return , because without a government mandate , companies are very unlikely to move to true net zero . Companies could change their model as these technologies and methods lead to consolidation and higher profits . How much regulatory approval might be needed would have to be defined .
The task at hand is not easy but if things were easy , everything would have been done already . The question going forward for us is ‘ Are we willing and able to take up the challenge of reducing emissions ?’ We have a choice . For the sake of future generations , let ’ s make the right choice ●
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Figure 3
Figure 3 – Preparation of 2-chloro-4-bromobenzensuflfonyl chloride
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Girish Malhotra
PRESIDENT
EPCOT INTERNATIONAL girish @ epcotint . com http :// epcotint . com
References : 1 : J . Lang , ECIU , 20 January 2021 . https :// eciu . net / analysis / infographics / net-zero-history 2 : R . A . Sheldon , Green Chemistry , 2017 , 19 , 18 – 43 . https :// pubs . rsc . org / en / content / articlehtml / 2017 / gc / c6gc02157c 3 : G . Hubbard , Strategy + Business , 29 May 2007 . www . strategy-business . com / article / 07203 4 : G . Malhotra , in Chemical Process Simplification : Improving Productivity & Sustainability , John Wiley & Sons , February 2011 . 5 : G . Malhotra , Simplified Process Development & Commercialisation , in Quality by Design - Putting Theory into Practice , PDA / DHI Publishing , February 2011 .
6 : G . Malhotra , Active Pharmaceutical Ingredient Manufacturing : Non-destructive Creation , De Gruyter , April 2022 . 7 : G . Malhotra , Profitability through Simplicity , 2024 . https :// pharmachemicalscoatings . blogspot . com / 8 : O . Levenspiel , Chemical Reaction Engineering , John Wiley & Sons , 1972 . 9 : G . Malhotra , Sociochemicology , 30 May 2013 . https :// www . youtube . com / watch ? v = 48oZEA-az1U 10 : Shreve & R . Norris , Unit Process in Chemical Processing , Industrial & Engineering Chemistry , 1954 , 46 ( 4 ), 672 – 672 . 11 : Wikipedia , Unit Operation . https :// en . wikipedia . org / wiki / Unit _ operation
12 : G . Malhotra , Profitability through Simplicity , 7 November 2018 . https :// pharmachemicalscoatings . blogspot . com / 2018 / 11 / quick-review-of-chemicals-related . html 13 : G . Malhotra , Profitability through Simplicity , 29 May 2023 . https :// pharmachemicalscoatings . blogspot . com / 2023 / 05 / capitalizing-on-mutual-behavior-and . html 14 : G . Malhotra , Review of Continuous Process for Modafinil , Continuous Processing in the Chemical & Pharmaceutical Industry II , Annual Meeting , 10 November 2009 , Nashville . 15 : G . Malhotra , Pharmaceutical Engineering , 2009 AIChE Annual Meeting , 11 November 2009 , Nashville . 16 : G . Malhotra , AIChE , 17 May 2023 .
17 : G . Malhotra , Profitability through Simplicity , 20 April 2019 . https :// pharmachemicalscoatings . blogspot . com / 2019 / 04 / considerations-to-simplify-organic _ 77 . html 18 : G . Malhotra , Profitability through Simplicity , 17 August 2010 . https :// pharmachemicalscoatings . blogspot . com / 2010 / 08 / square-peg-in-round-hole-does-this . html 19 : G . Malhotra , Profitability through Simplicity , 10 April 2011 . https :// pharmachemicalscoatings . blogspot . com / 2011 / 04 / information-challenges-for-product . html 20 : U . Schrader , McKinsey & Co ., 21 February 2021 . 21 : McKinsey & Co ., What is Net Zero ?, 25 October 2024 . 22 : G . Malhotra , Profitability through Simplicity , 2 October 2024 . https :// pharmachemicalscoatings . blogspot . com / 2024 / 10 /
28 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981