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"Single-Use" Tubing and Peristaltic Aseptic Filling Machines

December 2008

Watson-Marlow Flexicon Peristaltic PumpNew drug development today focuses largely on bio-pharmaceuticals rather than chemicals, meaning that the resultant drugs tend to be injectable liquids instead of solids. Furthermore, the new drugs are typically designed for specific populations, hence batch sizes are smaller.

Paralleling these two trends are ongoing pressures to increase efficiency, reduce costs and minimize risks - including cross-contamination between batches. Additionally there is a need for a reduction in the time involved in validation procedures (e.g. paperwork and man hours). Taken together, these factors point towards peristaltic pumps with single-use tubing or tubing sets as representing the future for bio-pharmaceutical fill/finish lines.

Traditionally, fill/finish lines have used piston pumps but, in today's bio-pharmaceutical production environment, piston pumps suffer from a number of drawbacks, one being that piston pumps contain numerous contact parts that must be dismantled, cleaned and sterilised between batches of different product.

As batches become smaller, there is a need to shorten changeover times. Even if duplicate pumps are purchased to achieve faster changeovers, each pump still needs to be stripped, cleaned and sterilized - and a small risk of cross-contamination between batches will always remain. In contrast, the only component of a peristaltic pump that comes into contact with the product is the tubing. If the tubing is a single-use item that is supplied pre-sterilized, the need for cleaning and sterilization is eliminated, as is the risk of cross-contamination.

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Watson-Marlow Flexicon
37 Upton Drive
Wilmington MA 01887
Phone: 978-658-6168
Fax: 978-658-0041
http://www.watson-marlow.com

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