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PROCESS Worldwide-PharmaTEC 01-2003

Paradigm change in solids production

This is an area in which changes in the basic economic conditions and technical advances in process engineering now offer the best prerequisites for a paradigm change, for example in pharmaceutical solids production.
Whereas pharmaceutical solids have traditionally been manufactured batchwise, creative plant constructors are of the opinion that the production of many of them could now be changed to a basically more cost favourable continuous process. After all, present measurement technology possibilities enable all continuous process measurement parameters to be redundantly performed, i.e. all measured values can be checked twice with great certainty, and so guarantee that the process does not run off course.

The quasi-certainty of the data collection of a batch is so passed over to the continuous process. The benefits would appear to be apparent: In particular, alongside the safety requirements spoken of, the brief transition phase that is required to change the size of production from small amounts to large quantities. This is achieved by simply using the same plant and running it for a limited time period for small amounts, then producing large quantities by running it continuously for 24 hours a day, 7 days a week. Naturally automatically.
This would give pharmaceutical companies a considerable economic added value, as they would save scaling-up from a laboratory or pilot plant scale to large scale production. The plant constructors are confident that all of the difficulties that could crop up during scaling-up would be hereby eliminated. Another great benefit is that practically no time would be lost between the end of clinical tests and the start of production, which presently takes an average time of about six months.
Big pharma marketing experts have estimated that such an acceleration of the start of production would generate 500 million euros of additional turnover for a typical blockbuster! This incredible amount at least gives food for thought!

- Gerd Kielburger -

 


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