Raw materials

  • WACKER-CHEMIE (Niemcy)
  • DOW CORNING (USA)
  • RHODIA (Francja)
  • GE-Bayer

 

Characteristicts

Working temperature (standard compounds) -50°C do +180°C / +250°C
Working temperature (specific compounds) -90°C do +315°C
Elongation 300-800%
Hardness 25 do 80 Shore A
Breakdown voltage 23 kV (VDE 0303)

 

Materials for specific applications

  • High chemical resistance
  • Good damping of high and low frequency vibrations
  • Silicon rubber products are tasteless and odourless
  • Resistance to ageing and weather conditions

 

Colors

The colour of silicon products can be suitably chosen for particular application: from transparent to black, in accordance to RAL, including metallic colours (aluminium, steel, brass).
The colours feature of vividness and durability

 

Physiology characteristics of silicone

The usage of silicone in pharmaceutics and food industry is regulated by each country standards.


Industry

Niemcy

BgVV XV, Teil A, "Silicone", 182. Mitteilung BGBI. 32, 211 (1989) BgVV IX, Teil A, "Farbmittel zum Einfärben von Kunststoffen und anderen Polymeren für Bedarfsgegenstände" , 178. Mitteilung BGBI. 31,363 (1988) "Kennzeichnung von Bedarfsgegenständen im Sinne des Lebensmittelgesetzes" DIN 7725 KTW - Empfehlung, BGBl. 28, Nr. 12 (1985)


USA

"Rubber Articles Intended for Repeated Use", FDA - Code of Federal Regulation, § 177.2600


Francja

"Décrets et Circulaires du Ministère de I´Agriculture", Brochure No. 1227


Anglia

BS 6920 (WRc Water Byelaws Scheme)


Parmaceutics

Niemcy


"Gummiteile" - Transfusion, Infusion, Injektion DIN 58367
"Infusionsgeräte" - Infusion, Transfusion DIN 58362


USA

"Biological Tests - Plastics"
United States Pharmacopoeia


Francja

"Silicone Elastomère réticulé á chaud"
Französische Pharmacopoeia


Europa

"Silicone Elastomers for Closures and Tubing" European Pharmacopoeia PA / PH / Exp. 3/ T (82) 57 Definitive January 22, 1985
Commission Directive 93 / 11 / EEC "Release of N-nitrosamines and N-nitrosable substances from elastomer or rubber teats and soothers" (1993)

Guidelines for medicine usage

These guidelines relate to the use of silicone products in the manufacture of medical devices.

We do not sanction the use of our products for and do not sell into long term implant applications defined as greaterthan 30 days. In no case will we sanction the use of our products for the following applications:

  • Cosmetic reconstruction (eg, plastic surgery, prosthetic devices).
  • Devices for gynecological or obstetric applications (eg, pessaries, tampons, vaginal stents) except for diagnosis and monitoring and surgical instruments.
  • Contraceptive or reproductive devices (eg, condoms, condom lubricants, intrauterine devices, cervical caps).
  • Free injection including the use of silicone fluids where they can be introduced directly into tissues, body cavities or blood (eg, syringe lubricants, intraocular fluids).

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