December 2009

Eliminating Product Contamination

Packaging and labeling can directly influence the use of pharmaceutical products, and recent innovations are focusing on improving product and patient safety. One definite threat is product contamination, and packaging is integral to maintaining product safety.

At Pharmapack 2010, Promens will discuss the development of its new tube closure system that keeps a sterile formulation intact and safe from contamination throughout duration of use. The D.E.F.I system consists of four parts, including a supple membrane that rises when pressure is applied to the tube and later resumes its position when pressure is released.

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Isabelle Orhan, director of innovation, marketing, and development, Promens, will be joined by Vincent Cazelles from Pierre Fabre Group, to share how the D.E.F.I. system is being used for Pierre Fabre/Avène’s Tolérance Extrême, a dermo-cosmetic free of preservatives, perfume, and surfactant. According to Orhan, D.E.F.I allows the use of sterile products without preservatives in a large-size tube. “This ensures the consumer a most practical use, compared with monodoses/unidoses/single-dose packaging,” she explains.

The D.E.F.I. cap employs high-precision parts manufactured to one hundredth of a millimeter. They provide flawless cohesion with the entire unit, Orhan adds. The lid can be sized to the cap with no gaps and closed with a tamper-evident clip removed when the tube is first opened.

D.E.F.I. is a French acronym that stands for Dispositif Exclusif Formule Intacte (exclusive intact formula device). To maintain product sterility, the product itself is sterilized, and then filled aseptically into tubes.

Orhan’s and Cazelles’s presentation on February 2, 2010, “The First Patented Sterile Distribution System,” will be part of the larger session, “Packaging, Compliance, and Patient Safety.” This half-day event will be chaired by Professeur Philippe Arnaud, Pharmacien des hôpitaux - Chef de service, Hopital Bichat-Claude Bernard AP-HP, Paris, and Sébastien Fily, Packaging development manager, Bayer Santé Familiale, France.

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