WACKER CLEAN OPERATIONS – Production Standard for Medical-Grade Silicones
Medical-grade silicones come into direct contact with human skin. Consequently, silicone-based products for this application area must satisfy the most stringent of demands on quality, reliability and safety. This is the thinking behind WACKER CLEAN OPERATIONS.
This cutting-edge production standard
- Complies with ISO 13485, the QM standard for the manufacture of medical products (insofar as it is relevant to us as a raw-materials producer)
- Encompasses selected GMP criteria
Thanks to WACKER CLEAN OPERATIONS, when you use our SILPURAN® silicone products, you can be assured that their purity has been verified, they have been produced with the utmost care and their quality is consistent – this is fully traceable all the way back from the end product through to the raw-material source.
- SILPURAN® silicone rubber grades are filled or packaged in Class 8 cleanrooms to prevent contamination.
- Visual inspection and 50-μm filters ensure that SILPURAN® reaches our customers in an absolutely pure and clean state.
SILPURAN® contains only precisely-defined ingredients, such as siloxanes, silica and crosslinkers/catalysts. Since the glass transition temperature is low (Tg = -125 °C), there is no need to add organic plasticizers, which could be released from the rubber.
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