| 1. Mixing the two componentsThe components A and B are mixed by weight in the above indicated ratio. The mixing can be carried out either by hand or by using a low-speed electric or pneumatic mixer to minimise the introduction of air and to avoid any temperature increase.
It is also possible to use a special mixing and dispensing machine for the two silicone components. Further information is available upon request.
2. Degassing
The mixture should be degassed preferably at 30 to 50 mbar to eliminate any entrapped air. If a dispensing machine is used, the two components are degassed separately prior to mixing.
The silicone mixture expands to times of its initial volume and bubbles rise to the surface. Wait a few minutes to complete the degassing and then flash the vacuum. The silicone is ready for pouring, either by gravity or under low pressure.
Note: Flashing the vacuum once or twice accelerates the degassing. It is recommended to use a container with a high diameter / height ratio.
3. Polymerisation
The system polymerises at 23°C. The curing may be slowed down at lower temperature or accelerated by heat.
Contact with certain materials can inhibit the crosslinking. See list below: - Natural rubbers vulcanised with sulphur.
- RTV 2 silicone elastomers catalysed with metal salts, e.g. tin-compounds.
- PVC stabilised with tin salts and additives.
- Epoxy resins catalysed with amines.
In case of doubts, it is recommended to test the substrate by applying a small quantity of the mixed silicone on a restricted area. Biocompatibility testing addresses the categories of evaluation for cytotoxicity, skin sensitization and skin irritation specified in USP Class VI and / or ISO 10993 for device use of less than 30 days duration.
Silbione silicone products may be used for healthcare applications in accordance with ELKEM's healthcare product guidelines. ELKEMSilicones supports the sales of these Silbione silicone products to customers involved in manufacturing and assembling approved medical devices for less than 30-day implantation. The purchaser has the sole responsibility to select a particular Silbione silicones product and determine its application suitability. The purchaser also has the sole responsibility to comply with all applicable statutory, regulatory and industry requirements and standards for compatibility, extractability, testing, safety, efficacy, and labeling.
Bioburden testing, ie measure of the total number of viable microorganisms (total microbial count), for example prior to sterilization of the final medical device, is not provided for Silbione RTGel products. Should your application request bioburden testing for the silicone raw material, please contact your local Elkem Silicones Sales Representative to discuss Elkem Silicone’s Silbione HC2 product range. | SILBIONE RT GEL 4320 FC A may be stored at temperatures between -10°C / 14°F and 30°C / 86°F for up to 12 months from its date of manufacturing. | | | Please consult the Safety Data Sheet of this product. | | | SILBIONE RT GEL 4320 FC A | SILBIONE RT GEL 4320 FC A&B is a two component silicone elastomer which cures at room temperature by a polyaddition reaction. The polymerisation can be accelerated by heat.
The silicone material is delivered as two low viscous liquid components, which once mixed and cured, transform into an elastic gel. Polymerisation occurs without formation of heat. | Adhesion;Bio-compatibility | 2 Part RTV | | | - Very good adhesion on dry skin.
- No adhesion on moist wounds.
- Proven biocompatibility.
- No free oil.
| - Adhesive wound dressings.
- Adhesive sheets for scar treatment.
| Asia Pacific;Europe Middle East Africa;Central and South America;North America | | | |
