Manufacturing of SmartDose^® is executed in a clean-room environment following validated processes. All our procedures - in house and at our subcontractors - follow a quality management system validated and periodically certified according to ISO 9000 and EN ISO 13485 standards.

The majority of our manufacturing and assembly operations is performed on automated production lines with numerous integrated 100% in-process inspections, to assure a maximum level of quality. The high degree of production automation allows a scalable manufacturing output up to several thousand units of SmartDose^® per day.

To assure compliance with the widest possible range of pharmaceutical substances, the SmartDose^® infusion pump is constituted of inert materials, mostly polypropylene copolymers (no latex, no PVC). For the same reason we have chosen friction welding technologies and are thus able to avoid using solvents or adhesives.

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

The currently utilized materials allow for sterilization by moist heat according to pharmacopoeial standard procedures.

SmartDose^® infusion systems designed as a primary packaging material for an aseptic filling may also be sterilized with ethylene oxide. Where high dose radiation is required other materials than polypropylene are more suitable. PRO-MED is currently establishing SmartDose^® infusion systems specifically designed for high dose ß & y sterilization.

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