HiSiaddi is an innovative foreign trade service provider driven by both technology transformation and export business. We have established a "1+2+3+4=1" service system and can supply FEP resins from multiple well-known original manufacturers. As a foreign trade service provider with independent R&D capabilities, HiSiaddi has long-term technical transformation cooperation with manufacturing plants and an accurate grasp of market demands, enabling us to repeatedly resolve customized requirements for FEP resins. Below is a case where HiSiaddi delivered a full customized FEP resin solution.
Please contact HiSiaddi customer service if you require customized product services.
MedCable GmbH is a listed German specialist enterprise focusing on minimally invasive medical consumables, ranking among Europe’s top producers of interventional medical cables and insulation materials for minimally invasive catheters. It supplies Siemens Healthineers and the German Federal Institute for Medical Devices, specializing in insulating jackets for cardiac interventional catheters and insulated wires for high-frequency surgical electrodes. The company procures FEP (tetrafluoroethylene-hexafluoropropylene copolymer resin, CAS: 25067-58-7) of medical grade from DuPont all year round, with an annual FEP resin procurement volume of 260 tons. Its raw materials must comply with USP Class Ⅵ biocompatibility standards, EU REACH Regulation and IEC standards for medical cable insulation, with the strictest industry controls over resin purity, melt flow rate, extractables and transparency for medical applications.
Due to capacity constraints among major European and American fluorochemical manufacturers, lead times for customized grades have extended to 120 days. At the Cologne International Medical Fair 2025, the client finalized cooperation with HiSiaddi (Shanghai HiSi Technology) to develop a customized ultra-low extractable transparent FEP grade for medical use, with an initial trial order of 40 tons. Previously, the client independently coordinated sample production with domestic Chinese manufacturers but failed to deliver viable customized products, and thus entrusted HiSiaddi with full overall management covering formula customization, process matching and compliance implementation.
Product Basics: FEP primary pellets, HiSiaddi Item Code: 3904690000, packed in 25kg moisture-proof paper drums lined with aluminum foil.
1. Custom copolymer ratio: Precise control of hexafluoropropylene (HFP) content at 14.2%±0.2%, melt flow rate (372℃/5kg) 12.5±0.4g/10min, compatible with the client’s high-speed precision extrusion line;
2. Medical-grade control: Fluoride ion extractables of resin <0.3ppm, no low-molecular oligomer precipitation, passing USP Class Ⅵ cytotoxicity testing; extruded tubes remain fully transparent without crystal spots after high-temperature processing;
3. Process compatibility: Compatible with the client’s staged extrusion process at 285~310℃, insulation wall thickness tolerance ±0.03mm for wires, no coating rupture, bubbles or fish eyes during high-speed extrusion.
1. Conventional domestic FEP manufacturers only mass-produce general cable-grade products and cannot fine-tune the copolymer ratio of TFE/HFP, resulting in batch-to-batch melt flow rate fluctuations exceeding ±1.8%, failing to meet precision extrusion thresholds;
2. Residual polymerization additives and low-molecular polymers in standard grades lead to excessive extractables after hot water immersion, failing German medical biocompatibility tests;
3. Production facilities lack dust-free polymerization and post-devolatilization workshops for medical-grade production, resulting in micro-impurities within the resin and abundant crystal spots on extruded finished products, rendering the material unfit for minimally invasive catheter insulation.
After 3 months of R&D and 8 rounds of unsuccessful sample trials, the client faced production stagnation for its new catheter product line due to a 32% price hike and delayed delivery of original DuPont raw materials.
HiSiaddi assigned fluorine material engineers to cooperate with partner fluororesin manufacturers for targeted modification via suspension polymerization:
1. Real-time online monitoring of TFE and HFP gas partial pressure during polymerization, closed-loop control of monomer feed ratios to stabilize HFP content at 14.2%, locking in melt flow rate stability from the source;
2. Addition of a three-stage negative-pressure high-temperature devolatilization post-polymerization process (290℃ vacuum treatment to remove small molecules) to eliminate residual monomers, low-molecular oligomers and emulsifying additives, strictly controlling fluoride ion extractables;
3. Optimization of the termination system with fully medical-grade fluorine-free residual additives, eliminating industrial-grade dispersants to align with USP medical compliance requirements.
Five batches of 50kg lab-scale samples were produced sequentially. All indicators including melt flow rate, extractables and transparency passed third-party laboratory testing in Germany.
1. HiSiaddi dispatched engineers to be stationed at the client’s facility in Germany. Based on the thermal stability of customized FEP, the extrusion temperature curve was re-optimized: barrel temperature from 288℃ to die head at 305℃, screw speed reduced by 15%, eliminating bubbles and coating rupture during high-speed extrusion;
2. Standardized pre-drying parameters for raw materials (120℃ for 12 hours dehumidification) were provided for ultra-fine wire coating to eliminate fish eyes caused by trace moisture in resin. After optimization, insulation wall thickness was stably controlled within tolerance, and production yield jumped from 52% in initial trials to 99.2%.
Industrial-grade monomers were phased out, replaced with high-purity electronic-grade TFE and HFP monomers sourced exclusively, with full chromatographic testing for each incoming monomer batch. A dedicated dust-free production workshop was established solely for medical-grade FEP for Germany, physically segregated from production lines for general industrial FEP. The exclusive grade was designated FEP-MED142 for German medical custom use. Each batch is accompanied by monomer ratio records and full physical property COA reports.
1. Handled EU REACH pre-registration for finished products and monomers, obtained ECHA registration numbers, and issued bilingual German-English MSDS documents;
2. Assisted with product testing at TÜV Germany to obtain USP Class Ⅵ biocompatibility and cytotoxicity certificates, fulfilling German medical device raw material filing requirements;
3. Optimized export packaging: vacuum aluminum foil lining + moisture-proof paper drums, constant-temperature warehousing prior to shipment to avoid resin property fluctuations induced by temperature changes during sea transit. Standardized domestic customs declaration and tax rebate procedures, and expedited customs clearance at the Port of Hamburg, Germany.
1. Short-Term Delivery: 40 tons of modified customized FEP were shipped to the Port of Hamburg, Germany on schedule. The client successfully launched mass production of its new series of minimally invasive interventional catheters, replacing imported DuPont raw materials with a 27% reduction in procurement costs and lead times cut from 120 days to 32 days;
2. Long-Term Framework Agreement: An annual framework procurement contract for 240 tons of customized FEP-MED142 was signed in H2 2025. R&D and customization of radiation-resistant modified medical FEP grades were launched simultaneously;
3. Industry Expansion: Leveraging this benchmark case with the leading German medical client, HiSiaddi established stable customized supply channels for medical-grade FEP in Europe by onboarding three additional high-end medical consumable manufacturers in Austria and Switzerland.
Please contact HiSiaddi customer service for more customized solution services.
+86-13120989737 
info@hisiaddi.com 
English
