SILPURAN® AUX 8251 RO
SILPURAN® AUX 8251 RO is a white, barium sulphate containing batch that is used as a radio-opaque additive for addition cured high consistency silicone rubber. SILPURAN® AUX 8251 RO is designed for medical applications in compliance with the WACKER SILICONES HEALTH CARE POLICY including implantation for < 30 days.
SILPURAN® AUX 8251 RO contains approx. 71 % barium sulphate which meets the requirements of the US and European Pharmacopoeia.
SILPURAN® AUX 8251 RO meets selected test requirements of ISO 10993 and United States Pharmacopoeia (USP) Class VI.
Spezifische Merkmale von SILPURAN® AUX 8251 RO
SILPURAN® AUX 8251 RO is used as an additive to get a radio opaque addition cure high consistency silicone rubber.
The following studies were performed on vulcanizates containing SILPURAN® AUX 8251 RO according to ISO 10993:
- Cytotoxicity (ISO 10993-5)
- Sensitation LLNA (ISO 10993-10)
- Pyrogenicity (ISO 10993-11)
The following studies were performed on vulcanizates containing SILPURAN® AUX 8251 RO 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 a suited HTV and SILPURAN® AUX 8251 RO 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® AUX 8251 RO is compatible with addition cure high consistency silicone rubber. SILPURAN® AUX 8251 RO and the high consistency silicone base rubber are mixed homogenously on a roll mill. The mixing ratio depends on the required concentration.
For detailed information please refer to the latest edition of our brochure "SOLID AND LIQUID SILICONE RUBBER - MATERIAL AND PROCESSING GUIDELINES".
Verpackung / Gebinde
SILPURAN® AUX 8251 RO 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® AUX 8251 RO 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.