Quick Answer

LSR molding delivers five critical advantages for medical and food-grade applications: ISO 10993/USP Class VI biocompatibility for medical use, FDA and LFGB compliance for food contact, extreme temperature resistance (-60 to +250°C), chemical inertness that resists degradation, and excellent mechanical properties including high tear strength and flexibility that last for years without hardening or cracking.

Medical-Grade Advantages

LSR meets the most stringent medical requirements: ISO 10993 biocompatibility (cytotoxicity, sensitization, irritation), USP Class VI certification, ability to withstand steam and EtO sterilization without degradation, radiolucency (MRI-compatible), and a smooth, non-porous surface that resists bacterial colonization. Applications include: surgical masks, breathing tubes, seals for medical devices, implantable components, and drug delivery system parts.

Food-Grade Advantages

For food contact applications, LSR offers: FDA 21 CFR 177.2600 compliance, LFGB and EU 1935/2004 certification, no plasticizer migration (unlike PVC), no bisphenol A or phthalates, resistance to oils and acidic foods, temperature range covering boiling water and freezer, and a non-stick surface for easy cleaning. Applications: baby bottle nipples, baking molds, kitchen spatulas, food storage seals, and beverage tube components.

Manufacturing Benefits

LSR injection molding is fully automated. The two-part liquid silicone is mixed in the machine barrel and injected into heated molds (150-200°C) where it cures in 15-60 seconds. No post-curing is required for most applications. Flash is minimal, and fully automatic degating is possible. Cycle times are comparable to thermoplastic injection molding. LSR also reproduces extremely fine detail -- down to 1-micron surface texture reproduction.

Why Choose SOMI Custom Parts

At SOMI Custom Parts, we offer LSR injection molding with the same quality systems as our precision CNC machining. Our cleanroom-compatible production environment supports medical and food-grade requirements. We provide full material certification documentation including FDA compliance certificates and ISO 10993 test reports. Our engineers help you select the right LSR grade (general purpose, high tear strength, optically clear, or electrically conductive) for your specific application.

Case Study

A medical device company needed baby bottle nipples that met FDA and EU food safety standards. The design required a 0.5mm wall thickness, smooth surface finish, and consistent flow rate through the nipple hole. SOMI produced the LSR tooling and molded 100,000 nipples per month. Each nipple passed FDA extractable testing and had ±0.05mm dimensional consistency. The client reported zero returns due to quality issues.

Industry Data

The global LSR market is growing at 8.2% CAGR, driven by medical device and baby product demand (MarketsandMarkets, 2025). LSR now accounts for 15% of all silicone products, up from 8% in 2020, as manufacturers switch from HCR (high-consistency rubber) to LSR for its faster cycle times and automation advantages. Medical applications represent 35% of LSR consumption.

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