Silicone Rubber Grades facilitate drug delivery to patients.
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Press Release Summary:
One-component Tufel I is suited for tubing applications such as catheters and IV lines, while 2-component Tufel III provides resilience and elastic memory in tubing for peristaltic pumps. Both platinum-cure, silicone elastomers are cured without peroxides that can product VOCs, and are compositionally compliant with FDA 21 CFR 177.2600 for indirect food contact. They can be sterilized using steam, gamma radiation, and EtO.
Original Press Release:
GE's Tufel* Silicone Rubber Grades Help Healthcare Providers Improve Accuracy in Fluid and Drug Delivery to Patients
WILTON, CONN. - Nov. 9, 2005 - An important focus for today's healthcare providers is reducing medical errors. This effort spans multiple areas, including improving accuracy in the delivery of fluids and drugs to patients. At the same time, providers want to find ways to control spiraling costs. At GE's Advanced Materials business, GE - Silicones has introduced two new lines of biocompatible1 silicone rubber for extruded tubing applications that can help provide consistency and precision in fluid delivery while offering potential savings from lower manufacturing costs and extended device life. GE's Tufel I elastomer, a one-component, ready-to-use, platinum-cure silicone elastomer, provides cost and performance benefits in tubing applications such as catheters and IV lines. GE's Tufel III elastomer is a two-component, platinum-cure silicone elastomer that provides high resilience and elastic memory, as well as low hysteresis for flow accuracy, in tubing for peristaltic pumps.
In addition to benefiting healthcare providers and patients, peristaltic pumps incorporating tubing made with GE's Tufel III silicone rubber are used by the pharmaceutical industry in production lines to obtain high precision delivery. Drug manufacturers also use transfer tubing, gaskets, and seals extruded from Tufel I elastomers to realize the processability benefits of a one part system while retaining the biocompatibility advantages of platinum cured silicone elastomers.
"Peristaltic pumps that deliver critical medication and nutrition to patients require high-performance tubing that can withstand repeated compression without deforming," said Eric Luftig, global Healthcare marketing manager, GE - Silicones. "Tubing made from highly resilient Tufel III silicone rubber not only helps provide precise delivery of fluids and drugs, but can also last up to twice as long as competitive materials, resulting in cost savings."
GE's Tufel III Silicone Rubber Delivers High Performance in Peristaltic Pump Tubing
Peristaltic pumps, such as volumetric infusion pumps, enteral pumps, and ambulatory pumps, use rotating rollers pressed against flexible tubing to create a pressurized flow of liquid. They deliver accurate and repeatable flow rates for precise metering and dosing.
The pump tubing must be totally compressed to provide a proper vacuum on the inlet side, which places significant flexural stress on the tubing walls. Tubing can experience permanent deformation that can alter flow rates. And differential stresses can cause cracking or splitting.
GE's Tufel III silicone rubber addresses these challenges by providing the following properties:
o Excellent elastic memory and resilience - indicates the material withstands repeated flexing
o Low hysteresis - indicates that there is minimal loss of elastic energy when an elastomer is dynamically deformed and allowed to return to its original configuration
o Low compression set without the need for post-bake - achieves long pump life and eliminates secondary post-bake operations which reduces tubing manufacturing costs
GE's Tufel III grade offers a number of other benefits; first, low compression set without a post cure. This property allows design engineers to use this material in various sealing applications. Second, eliminating the use of peroxide in the cure process addresses concerns over volatile organic compounds (VOCs) that can impact air quality or outgas into fluid or medication. In addition, the material is biocompatible and inert, and is compositionally compliant with FDA 21 CFR 177.2600 for indirect food contact. Additionally, it withstands high temperatures required for sterilization.
GE's Tufel I Silicone Rubber Streamlines Processing for Faster Cycle Times
Based on the patented Addisil* catalyst technology, GE's Tufel I elastomer's is supplied as a ready-to-use product that does not require mixing or additional quality testing. By eliminating these steps, GE's Tufel I may lower manufacturing costs by up to ten percent. Further, the material offers fast cure rates at elevated extrusion oven temperatures and has a long mixed shelf life of up to three months at room temperature.
Like the Tufel III elastomer grade, GE's Tufel I silicone rubber is cured without peroxides that can produce VOCs. It is compositionally compliant with FDA 21 CFR 177.2600 for indirect food contact and can be sterilized using steam, gamma radiation, and EtO.
Typical applications include: pharmaceutical tubing, fluid transfer tubing, gaskets, and seals.
About GE - Advanced Materials
The Advanced Materials business of General Electric Company is part of the Industrial business group and is headquartered in Wilton, Conn. Comprised of Silicones and Quartz, GE - Advanced Materials is a global leader in providing a range of high-technology materials solutions. GE's silicones portfolio includes silicone-based products and technology platforms, silanes, sealants and adhesives. GE's quartz portfolio includes high-purity fused quartz and ceramics materials. These materials solutions are used as springboards for innovation in hundreds of consumer and industrial applications ranging from car engines to biomedical devices to integrated circuits. Markets served include aerospace, agriculture, appliances, automotive, construction, electronics, furniture and furnishings, healthcare, home care, industrial, lighting, packaging, personal care, plastics, semiconductor, telecommunications, tire, transportation, and water purification. As a Worldwide Partner of the Olympic Games, GE is the exclusive provider of a wide range of innovative products and services that are integral to a successful Games. Experience more at http://www.ge.com/advancedmaterials.
o Tufel is a trademark of General Electric Company.
o Addisil is a trademark of GE Bayer Silicones.
1. Biocompatible: A representative lot of Tufel I elastomer has been tested according to USP Class VI methods (Intramuscular implantation, intracutaneous injection, and systemic injection). A representative lot of Tufel III elastomer has been tested to both USP Class VI methods (Intramuscular implantation, intracutaneous injection, and systemic injection) and to ISO 10993 (for <29 days contact duration only: products tested for the 7 of the 21 tests that are applicable to "wet" chemical).
Contacts
The Americas
Amelia Burkhart
GE - Advanced Materials, Silicones,
Wilton, Conn.
Tel: +1-203-761-1934
E-Mail: amelia.burkhart@ge.com
Europe
Robert Scheib
GE Bayer Silicones, Leverkusen, Germany
Tel: +49 2143040532
E-Mail: Robert.Scheib@ge.com
Asia
Junko Tsuda
GE Toshiba Silicones, Tokyo, Japan
Tel: +81 3 5772 5345
E-Mail: junko.tsuda@ge.com
