SILPURAN® - Wacker Chemie AG


SILPURAN®

Safely On the Drip

Intravenous (IV) drips are used to give infusions of nutrients, minerals and medication to patients to speed their recovery. The physician can adjust the flow rate of the IV regulator to deliver exactly the right dosage – neither too little nor too much. Manufacturers of these medical devices must follow the highest standards of safety, reliability and precision. “Two years ago, we began using a cleanroom to produce silicone rubber for medical purposes,” says Dr. Christoph Briehn, technical manager for Health Care in the Rubber Solutions business team at WACKER SILICONES.

The patient receives infusions of nutrients, minerals or medication via an intravenous drip.

“Here, we produce not only conventional silicones with the usual surface friction, but also novel elastomers with good sliding properties.” These new low-friction elastomers are opening the way to more widespread use of silicone elastomers in the field of medicine. Their advantages are beneficial not only to the end user but also to the production process itself – anywhere, in fact, where friction could cause problems during fabrication. The assembly of various parts (pushing tubes through other components, for example) is simplified.

Cleanroom at Wacker Chemie AG in Burghausen, where silicones are produced for medical purposes.

Lower Friction

Dominique Dupard, managing director at the French silicone processor Top Clean Silicone, had been looking for an elastomer to improve the performance of an IV flow regulator for a long time. “With SILPURAN®6600, we found a way of doing away with lubrication of the flow regulator valve,“ reports Dupard, also noting that demolding after injection molding is considerably easier. Incidentally, Top Clean Silicone did not need to change its manufacturing method to process this low-friction silicone – it can be injection molded just like any other liquid silicone rubber.

Gaskets of SILPURAN®6600 with low surface friction allow for easy and safe control of flow volume and drip rate.

All the Necessary Certificates

“Before we can offer our new flow regulator to an IV drip manufacturer, however, we need to have more than just an elastomer with the right properties,” explains Dupard. Of course WACKER takes care of the appropriate testing and certification itself.

SILICONES FOR MEDICAL DEVICES

Silicones have properties that make them especially suitable for use in medical devices:

  • They are chemically and physiologically inert: that is, they are compatible with the detergents and disinfectants used in health care, and with medication.
  • Their good thermal resistance enables them to be easily sterilized by heating. Furthermore, they are very well suited for sterilization by steam, gamma rays and ethylene oxide. Silicones hardly age, even under the influence of oxygen, ozone or radiation.
  • They do not take up water, yet are permeable to water vapor, air and other gases.
  • They are transparent, i.e. can be used to make see-through articles, yet they can be easily pigmented. Thus, they can take on a practically unlimited spectrum of colors.
  • They contain no additives such as organic plasticizers. Silicone elastomers consist entirely of synthetic polymers and therefore do not contain any plant proteins, which could trigger allergic reactions.
  • Silicones intended for medical applications are marketed by WACKER under the brand name SILPURAN®. They are available as high temperature-vulcanizing solid and liquid silicone rubbers, or as room temperature-vulcanizing silicone rubbers. All these products have been evaluated for their biocompatibility according to ISO 10993 and USP Class VI Testing. Great care is taken to meet the strictest purity standards during production and packaging.

Applications

Silicones currently account for two to three percent of the plastics used in medical devices.

Areas of application include:

  • Catheters (tubing, balloons, shaft)
  • Medical and pharmaceutical tubing, drainage
  • Moldings for medical devices, e.g. gaskets, valves and membranes
  • Stoppers for injection vials
  • Parts for pharmaceutical packaging, e.g. respiratory masks/face masks
  • Wound dressings and scar treatment
  • Orthopedic technology, truss pads, orthoses, dressings (bandages) etc.
  • Liners for prostheses