NuSil’s color masterbatches offer off-the-shelf pigmenting options for silicone devices intended for the medical device market. NuSil Technology and GSDI co-developed a line of silicone masterbatches for coloring liquid silicone rubbers (LSRs) and high consistency silicone rubbers (HCRs). The color materbatch can be used with NuSil’s line of unrestricted (long term implantable) and restricted (less than 30 day implant, or non-implant) silicone products.
The color masterbatches consist of pigments dispersed in vinyl functional silicone polymers that when
used in conjunction with platinum systems will participate in the elastomer’s curing process, becoming
part of the polymer matrix.
Benefits of using color masterbatches:
- Eliminate dry pigment contamination in clean room environments
- Reduce costly cleaning time
- Provide a means to easily pigment silicone elastomer systems
- Unparalleled color consistency
- Improved device aesthetics
- No ‘bleed' out will occur in the final cured state
- Minimal effect on physical properties
What differentiates NuSil’s color masterbatches from other color options in the medical device market is the level of biological testing performed on these materials. NuSil color masterbatches are supported by a full range of biocompatibility testing which meet USP Class VI and many ISO 10993 standards. U.S. FDA USP Class VI testing consists of systemic toxicity, intracutaneous reactivity, seven day muscle implantation, genotoxicity, pyrogenicity and sensitization testing are completed for restricted products; and, hemolysis and 90-day muscle implantation with histopathology studies are completed for the unrestricted products.
NuSil Silicone Color Masterbatches are offered in an array colors and in both opaque and translucent color palettes. Colors include: white, black red, orange, yellow green, dark blue and blue. Custom colors, obtained through the blending of eight base colors, are available upon request.
NuSil’s will also supply most any of its silicone products pre-colored as a ready to use material eliminating any color processing. For solid color masterbatches, the MED-4502 and MED-4102 series offer simple, accurate pigmentation of high-consistency silicone materials, which may be molded, calendared or extruded. The MED-4800 and MED-4900 solid color series and MED50-4800 and MED50-4900 translucent color series allow easy and precise pigmentation of LSRs and low-consistency materials, which may be injection-molded.
GSDI has been manufacturing color
and additive dispersions solely for the silicone industry for over 25 years.
Their products fall into two general categories: Standard and Custom.
Their “Standard” line consists of over
70 colors in either Gum or Paste (MQ and VMQ) form. The Standards are always on
the shelf and ready to ship. Each batch is manufactured and tested to ensure
both consistency of color and optimum dispersion of the pigment particles in
the silicone matrix. While the Standard Colors have been a mainstay of the
industry for over 25 years, we are especially proud of our work in the area of
Custom Colors. Our ability to match Pantone® or RAL® numbers reinforces our
position as the leader in the industry. With over 100 years of active
experience in matching and dispersing silicone colors, GSDI can quickly develop
a consistent, reliable product to meet your needs.
GSDI Contact Information
30 Second Street, S.W.
Barberton, Ohio 44203
(800) 4-GAYSON (USA)