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home > pmps > summer 2003 > api packaging - the next bulky issue
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Pharmaceutical Manufacturing and Packing Sourcer

API Packaging - The Next Bulky Issue

What weighs 20 kilos but fits into a small bag, is worth millions but only to its maker, will last a market six months but can be destroyed in seconds? The answer is active pharmaceutical ingredients (APIs).

As the pharmaceutical industry improves its cost-effectiveness, there have been significant developments in centres of excellence - central sites producing APIs for distribution to regional tablet and packaging facilities. The economies of producing APIs are dictated by batch sizes, and hence the drivers here are the same as with most batch production processes. One resultant effect of batch processes is the storage and transportation of bulk quantities of material, rather than the more continuous process typical when the API is made and consumed on the same site. This creates a new set of additional storage needs and requirements that are now making it onto the agenda of regulatory bodies such as the FDA.

Status Today

The expertise exists within pharmaceutical companies to match the regulators' requirements for data. For example, during the clinical phases of drug development, technologists examine and adhere to FDA guidelines and cGMP procedures to ensure suitability of the container closure system for the final packaging of drugs. Considerable time and resources are spent to develop primary packaging protecting the quality of the drug product. All this work is quantifiable by the shelf life. Even the secondary packaging is designed to enhance and/or protect the primary package. This has resulted in a unified and broadly standard approach to the materials, validation and documentation of primary and secondary packaging.


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By Nic Hunt, Global Business Director for Rexam Pharma Flexibles, and Frank Bieganousky, Montesini Associates LLC

Nic Hunt has worked globally in medical, pharmaceutical and personal care packaging for 15 years in research, process development, product development, marketing and business management. He is currently the Global Business Director for Rexam Pharma Flexibles and Rexam Pharma Services - focusing on developing new barrier systems and packaging solutions for the pharmaceutical industry.

Frank Bieganousky has over 20 years' experience in the pharmaceutical packaging industry in both commercial and technical development. He is currently providing consultancy services to pharmaceutical companies and their packaging suppliers. Prior to forming Montesino Associates LLC, he was most recently Director of Healthcare Business Development for TEKNIFILMS, a division of Tekni-Plex, Inc. He has held business development and marketing positions at Honeywell and Rexam Medical Packaging, as well as technical packaging development positions at Bristol-Myers Squibb and Becton Dickinson.


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Nic Hunt
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Frank Bieganousky
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