Medical Device Link.

NEWS

Engineering plastics formulator Ticona has begun production of its medical-grade Hostaform MT, a polyoxymethylene copolymer (POM), in a first-of-its-kind production facility at its Kelsterbach, Germany, site. Hostaform also plays a key role in the manufacture of insulin pens, ensuring dosages that are accurate to 1/1000th of a droplet.

The new, compact, closed-system production line comprises separate rooms as well as dedicated machines and pipelines. It was developed to ensure stringent adherence to regulatory requirements, to avoid production mix-ups, and to safeguard product purity. The compounding, extrusion, and packaging equipment is set up on three separate floors of a modest building in cleanable rooms of about 20 sq. m. Everything including the electrical casings can be quickly washed or brushed down. Even the machinery itself and the pipelines leading from room to room are designed for easy individual cleaning. The packaging and shipping room at the end of the process chain is larger to accommodate logistical needs.

The computer-controlled system provides complete quality management and produces accurate documentation that facilitates traceability of the individual formulation components back to their sources. Regular quality controls are carried out at each production stage and prior to dispatch, in compliance with U.S. FDA guidelines.

Approximately 90,000 tons of Hostaform, which is now available in some 10 grades, can be manufactured at the Kelsterbach plant. The site can also produce 20,000 tn of the long-glass-fiber-reinforced thermoplastics, Celstran and Compel. “Ticona is a growth-oriented company,” explains president Lyndon Cole. “In the last five years, we have watched the market in drug-delivery systems grow by 18 to 20% per annum in Europe and North America, and we are listening to our clients’ needs.”

Purity, biocompatibility, and sterilizability head the list of specifications for medical-grade plastics. Mechanical properties, tight tolerances, low friction and wear, high creep strength, and resistance to chemical media and corrosion are also important characteristics. Metering mechanisms used in dry-powder inhalers, for example, must have absolute dimensional stability in all climates. “The toughness and rigidity of POM makes it possible to produce delivery systems that meter drugs very precisely,” explains Stefan Disch, POM product manager.