Wide temperature range. Medical grade. Food safe.

LSR (Liquid Silicone Rubber): two-component liquid pumped into heated mold, cures in seconds. Best for high-volume precision small parts (medical, baby products, sensor seals). HTV (High-Temperature Vulcanized): gum stock consistency, compression or transfer molded, longer cycle times. Best for larger parts, lower volumes, gaskets. We work with both depending on volume and part geometry.

FDA 21 CFR 177.2600 compliance for food contact. Specific requirements: material traceability, post-cure process to eliminate volatiles, documented testing for food-simulant extractables. Platinum-cured silicone (vs peroxide-cured) preferred for food contact — no peroxide byproducts. We source certified food-grade compounds and document compliance for customer requirements.

USP Class VI biocompatibility certification required for medical devices. Specific tests: systemic toxicity, intracutaneous toxicity, implantation response. Medical silicone grades from specific suppliers (NuSil, Wacker, Shin-Etsu) come pre-certified. For implantable medical devices, additional customer qualification and traceability required. Standard medical device silicone work: clear documentation chain from raw material to finished part.

Correct — silicone is a thermoset, doesn't melt for reprocessing. Scrap and runners are generally waste. Newer LSR tooling designs include runnerless molds to minimize waste. For high-volume production, consider material cost in economics — silicone at $15-40/kg is expensive vs commodity thermoplastics.

Standard silicone: -50 °C to +230 °C continuous. High-temperature specialty grades: +260 °C. Above this, silicone degrades. Fluorosilicone: similar temperature range with added fuel resistance. Below -50 °C, silicone stays flexible unlike most elastomers — key advantage for cryogenic applications.

LSR injection mold tooling: $8,000-40,000 depending on part complexity and cavity count. Faster break-even than standard injection because silicone cycles are short (30-90 sec typical). For 10,000+ parts: tool amortization minimal per-part. For prototype or low-volume, compression molding with simpler tooling ($2,000-10,000) or machining from sheet may be more economical.