SILPURAN® 8630/60 is an addition-cure, two-component high consistency silicone rubber for the manufacture of extruded articles. The vulcanizates show good to very good mechanical properties and a low coefficient of friction. Compared to SILPURAN® 8030/60 the coefficient of friction is reduced by 50 - 70 %.
SILPURAN® 8630/60 is designed for medical applications in compliance with the WACKER SILICONES HEALTH CARE POLICY including implantation for < 30 days.
SILPURAN® 8630/60 meets selected test requirements of ISO 10993 and United States Pharmacopoeia (USP) Class VI. It is designed for medical applications in compliance with the WACKER SILICONES HEALTH CARE POLICY including implantation for < 30 days and is particularly suitable for the production of extruded articles having low coefficient of friction.
Thanks to addition cure, the vulcanization reaction is significantly faster compared to peroxide curing materials. No peroxide decomposition products are formed during vulcanization.
At service temperatures above approx. 180 °C the addition of suitable heat stabilizers is recommended. Further information about an improvement of the heat stability by use of specific ELASTOSIL® AUX Heat Stabilizers can be obtained from the Technical Information Sheet "ELASTOSIL® AUX Stabilizers H" or the latest edition of our brochures
The following studies were performed on vulcanizates of SILPURAN® 8630/60 according to ISO 10993:
- Cytotoxicity (ISO 10993-5)
- Sensitation LLNA (ISO 10993-10)
- Pyrogenicity (ISO 10993-11)
The following studies were performed on vulcanizates of SILPURAN® 8630/60 according to USP class VI:
- Acute systemic toxicity
- Intracutaneous toxicity
- Implantation test
No adverse effects have been detected at any of the studies performed.
Properly cured and post-cured vulcanizates of SILPURAN® 8630/60 can be used for food contact applications and are suitable for use under the Recommendation "XV. Silicones" of the BfR and FDA 21 CFR §177.2600 "Rubber Articles Intended for Repeated Use" considering any given limitations on extractable and volatile substances.
SILPURAN® 8630/60 may not be cured with peroxides, but only with the catalyst batch SILPURAN® Curing Agent X. SILPURAN® 8630/60 and SILPURAN® Curing Agent X are mixed homogeneously on a roll mill in a ratio of 100 : 2.0. Care must be taken to keep the mill and compound as cool as possible during mixing. The temperature of the rubber should not exceed 35 °C, since otherwise there is a risk of premature curing seriously reducing the pot life.
Crosslinking begins after SILPURAN® Curing Agent X has been added. The rate and degree of crosslinking depend on the storage time and temperature. At 23 °C, the mixture has a pot life of about 24 h. This can be extended by storing the catalyzed mixture at a lower temperature.
For detailed information please refer to the latest edition of our brochure "SOLID AND LIQUID SILICONE RUBBER - MATERIAL AND PROCESSING GUIDELINES".
SILPURAN® HCR is delivered in blocks (profile diameter = approx. 90 x 100 mm) that are wrapped in an antistatic film and heatsealed in a bag. The customer can thus be sure that the material is not contaminated before it enters the cleanroom. SILPURAN® HCR is packaged in accordance with class 8 clean room standards (DIN EN ISO 14644).
SILPURAN® is neither produced nor packed under sterile conditions, so the final product has to be sterilized prior to use, if necessary.
Please store the cardboard boxes in a dry and cool place. Once opened, cardboard boxes should always be resealed after use to avoid any contamination and to prevent the platinum catalyst from being poisoned by amines, sulphur or phosphorus compounds. The 'Best use before end' date of each batch is shown on the product label. Storage beyond the date specified on the label does not necessarily mean that the product is no longer usable. In this case however, the properties required for the intended use must be checked for quality assurance reasons.