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MANUFACTURING
MANUFACTUIRNG PROCESS FLOW
QUALITY ASSURANCE
MANUFACTURING
MANUFACTURING

The majority of the manufacturing steps during the SmartDose® assembly are executed by validated subcontractors in adequate clean-room environments. All our procedures - in house and at our subcontractors - follow a quality management system validated and periodically certified according to ISO 9001 and EN 46001 standards.

Most of the manufacturing and assembly operations are performed on automated production lines with numerous integrated 100% in-process inspections, to assure a maximal quality level and minimal reject rate.

The high degree of production automation allows a scalable manufacturing output up to several thousand units of SmartDose® per day with just a limited number of skilled operators.

To assure compliance with the widest possible range of pharmaceutical substances, the SmartDose® infusion pump is constituted of innert materials made of polypropylene polymers (no latex, no PVC). For the same reason we have chosen the friction welding technique and were able to avoid using solvents or adhesives.

Product expedition and shipping is managed from our central warehouse location in Linz, Austria.

 

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SMARTDOSE
© 2004 PRO-MED Medizinische Produktions- und Handels-AG   Wiener Str. 131    A 4020 Linz   phone:+43 732 33 60 33 - 0   fax:+43 732 33 60 33 46
 403 111 (03/04)