Does your CRO have a continuous efficiency program in place?

Some products seem to stick around and thus become part of the lore at many fine chemical manufacturers.

Posted: January 8, 2013

API Manufacturing and Pharmaceutical Manufacturing

PCI has its own share of legacy processes that people refer to as the old friends. By the same token they often appear to be well known, fully optimized, and were developed years ago without any possibility for additional improvements.

It is part of PCI’s brand promise to its customers to undertake continuous efforts to increase the efficiency in its manufacturing.   Recently PCI’s chemists revisited one of its older, commercialized products to take a fresh look at the chemistry and figure out if one can streamline the manufacturing process using contemporary process development thinking.

Recently, PCI’s scientists conducted a thorough investigation of a product that had been developed and made at PCI for almost10 years.

Highlights of the new development:

  • Addition times for reagents and the temperature ranges during reactions were optimized resulting in a more robust process
  • A different base was used leading to a more controllable reaction
  • A new solvent was introduced facilitating filtration and drying of the solids
  • A thorough mass-balance analysis was performed creating a complete picture of the material distribution during several days of processing in the Plant

Several tangible results were achieved. Among them:

  • Product Quality – purity of the final product was dramatically improved to 99.5%
  • Yield was increased by 10-12%
  • Residence time in the reactors was decreased by 10%
  • Volume reduction was achieved at 10% level

Fresh thinking, attention to detail, and an open minded approach brought about an overall increase in efficiency of more than 20%!

With the greater manufacturing efficiency PCI is able to pass along savings to its customer while creating more capacity to manufacture other products-Everybody Wins!!

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About the Author

Ed Price CEO of PCI Synthesis
Ed is the President and CEO of PCI Synthesis (PCI), he serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA).

Do you have questions? Talk to Ed.