Isolator Technology for Aseptic Filling of High Potent Products

Apr 17, 2013
By PharmTech Editors

PIERRE FABRE MEDICAMENT PRODUCTION owns a manufacturing site in the south of France, which has some of the largest experience worldwide with 22 years usage of isolator technology for aseptic filling of high potent freeze-dried injectable products.

Its newest generation of cytotoxic suites were built a few years ago to manufacture new products in compliance with worldwide CGMP and European ATEX regulation. All process operations: dispensing, compounding, filling, lyophilization, capping and external decontamination of the vial, are done under isolator technology. PFMP has developed an innovative filling line with Washing In Place system and Sterilization In Place system of the isolators with built-in Vaporized Hydrogen Peroxyde generator. These two new suites were granted “Most Advanced Facility of the Year” by European Outsourcing Awards in 2008.

PFMP proposes to its partners a full CDMO service with full Development of Product and Active Ingredient, Contract Manufacturing of API and Finish Product including freeze-drying cycle development. Its main objective is always to offer process technology innovation to manufacture future products and to guaranty the compliance with the evolution of the Quality criteria as well as the Environmental and Safety conditions.

PIERRE FABRE MEDICAMENT PRODUCTION
Contact: Franck PAVAN, Outsourcing & Business Development Manager
Email: franck.pavan@pierre-fabre.com
Website: www.aquitaine-pharm.com