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Medical & Food-Grade Elastomer Factory

Medical & Food-Grade Elastomer Manufacturers

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Product Overview

Zhongli's Medical and Food-Grade Elastomer series is a purpose-built line of hydrogenated styrenic block copolymers (SEBS) formulated to meet the stringent purity, extractables, and regulatory requirements of healthcare device manufacturers, pharmaceutical packagers, and food-contact product producers. Unlike general-purpose SEBS grades, these materials are manufactured using pharmaceutical-quality raw materials, processed on dedicated production equipment, and released only after batch-level extractables testing and traceability documentation — practices aligned with GMP principles applicable to polymer raw material supply.

The result is a halogen-free, plasticizer-free elastomer that combines the softness, clarity, and flexibility demanded by end-users with the compliance documentation required by regulatory bodies in the United States (FDA), European Union (EU 10/2011, EU MDR), and international markets. From IV tubing and bottle closures to infant feeding products and food packaging seals, Zhongli medical and food-grade SEBS enables product developers to replace legacy PVC formulations with a cleaner, safer, and more sustainable alternative — without compromising processability or end-product performance.

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The development of Zhongli Technology's product series has gone through stages such as (1) universal grade SBS and SEBS, (2) special specification SEBS and universal grade SEPS, and (3) special specification SEP (S).

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Technical Specification Sheet

Parameter Detail
Polymer BaseHydrogenated Styrene-Butadiene Block Copolymer (SEBS)
Available GradesSEBS-M100, SEBS-M200, SEBS-M300 (hardness range: Shore A 50–80)
Styrene Content27–35% (grade-dependent)
HardnessShore A 50 – 80
Tensile Strength≥15 MPa (ISO 37)
Elongation at Break≥600% (ISO 37)
Extractables Level<0.5% (USP <661> methodology); <0.3% for M200
Heavy MetalsNot detected (<1 ppm, ICP-MS)
Sterilization CompatibilityGamma (25–50 kGy), EtO gas, Steam autoclave 121°C / 15 min
Light Transmittance≥88% (3 mm specimen, ASTM D1003)
Food Contact ComplianceFDA 21 CFR 177.1810; EU Regulation 10/2011
Biocompatibility (M200)ISO 10993-5 (cytotoxicity); ISO 10993-10 (sensitization)
Product FormNatural pellet (water-white); 20 kg or 25 kg sealed PE-lined bags
TraceabilityFull batch traceability from monomer to finished pellet; lot-specific COA

* ISO 10993 test reports available under NDA for SEBS-M200. Compliance documentation package (COA, SDS, DoC, extractables report) provided with every production shipment.

Key Features

  • Halogen-Free, Plasticizer-Free Formulation: Contains no PVC, phthalates, DEHP, or heavy-metal heat stabilizers — directly addressing global regulatory and procurement requirements that are phasing out legacy flexible PVC in medical devices and food-contact applications.
  • Low Extractables Profile Verified by Batch Testing: Every production lot undergoes extractables testing per USP <661> protocols before release. Results are documented in a lot-specific COA, giving downstream compounders and device manufacturers the data needed for their own regulatory submissions without redundant in-house testing.
  • Validated Across Three Sterilization Modalities: Gamma, EtO, and autoclave compatibility data are available in grade-specific datasheets, allowing device designers to select sterilization method based on their process without reformulating — a significant time saving in product development.
  • Water-White Clarity for Visual Inspection Applications: High light transmittance (≥88%) in the natural grade enables direct visual monitoring of fluid flow in tubing and reservoirs — a critical functional requirement for IV sets, peristaltic pump tubing, and diagnostic cartridges.
  • Full Regulatory Documentation Package Included: Zhongli provides FDA 21 CFR compliance letters, EU Declaration of Conformity (DoC), ISO 10993 test reports (M200), and batch traceability certificates as standard deliverables — reducing the administrative burden on your regulatory affairs team and accelerating time-to-market.

Application

  • IV Tubing & Medical Fluid Handling: Transparent, kink-resistant SEBS tubing that withstands repeated flexing and is compatible with standard medical-grade plasticizer-free compounding.
  • Stoppers, Caps & Closures: Injection-moldable SEBS grades replace PVC and latex in pharmaceutical bottle stoppers and vial closures, eliminating leachable plasticizers.
  • Baby Care & Infant Products: Pacifiers, teethers, and bottle nipples formulated from Zhongli food-grade SEBS meet stringent migration limits and retain softness across repeated sterilization cycles.
  • Food-Contact Packaging Seals: Gaskets, lid seals, and flexible membranes in food packaging lines where taste and odor neutrality are mandatory.
  • Surgical & Diagnostic Device Components: Grips, overmold layers, and soft-touch interfaces for handheld medical devices leveraging SEBS's comfort and chemical resistance.
  • Pharmaceutical Blister & Film Packaging: SEBS-based film layers in multilayer pharmaceutical packaging offering moisture barrier and flexibility at low temperatures.

Advantage

  • Halogen-Free & Plasticizer-Free: No PVC, phthalates, or heavy-metal stabilizers — directly addressing the regulatory shift away from traditional flexible PVC in medical devices.
  • Low Extractables Profile: Rigorously tested to USP <661> and ICH Q3D guidelines; minimizes risk of leachable substances migrating into drug products or foodstuffs.
  • Sterilization Compatibility: Validated for gamma irradiation (up to 50 kGy), ethylene oxide (EtO), and steam autoclave without significant degradation of mechanical properties.
  • Excellent Clarity & Aesthetics: High light transmittance and water-white color for applications requiring visual inspection of fluid contents or product presentation.
  • Regulatory Documentation Support: Zhongli provides comprehensive documentation packages including FDA letters of no objection, EU Declaration of Conformity, and ISO 10993 test reports to accelerate your product registration.
  • Consistent, Traceable Manufacturing: Each production lot is assigned a unique batch number with full traceability from monomer to finished pellet, supporting GMP audit requirements.

Payment & Shipping

  • Accepted Payment Terms: T/T in advance for sample orders; T/T 30% deposit + 70% before shipment, or L/C at sight for production orders.
  • Minimum Order Quantity: 100 kg for medical-grade SEBS (due to dedicated production runs); sample quantities 0.5–2 kg available for regulatory testing and compounding trials.
  • Lead Time: Standard medical grades: 15–20 business days from order confirmation. Expedited options available for established accounts.
  • Packaging: 20 kg or 25 kg sealed PE-lined craft bags on hygienic pallets; lot number, production date, and COA reference printed on each bag. Custom labeling available.
  • Shipping Options: Sea freight (FCL/LCL) from Ningbo/Shanghai; air freight for urgent medical supply chain requirements. Temperature-controlled logistics available on request.
  • Documentation: Full GMP documentation package: COA, SDS, Declaration of Conformity, extractables test report, and batch traceability certificate included with every shipment.
Message Feedback
ABOUT ZHONGLITEC
Coming From China,
Marketing To The World.
Zhejiang Zhongli Synthetic Material Technology Co., Ltd. is China Medical & Food-Grade Elastomer Manufacturers and Wholesale Medical & Food-Grade Elastomer Factory,was established in May 2015, invested by Zhejiang Zhongcheng Packing Material Co.,Ltd.(Share No.:002522).While the annual production of 120,000 tons of thermoplastic elastomer materials project was launched in November 2015.
Zhejiang Zhongli Synthetic Material Technology Co., Ltd. ABOUT US Zhejiang Zhongli Synthetic Material Technology Co., Ltd.
Zhejiang Zhongli Synthetic Material Technology Co., Ltd.
Zhejiang Zhongli Synthetic Material Technology Co., Ltd.
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Cooperative Clients

  • Q: Does Zhongli's medical-grade SEBS comply with FDA requirements?
  • A: Yes. Our SEBS-M100 and SEBS-M200 grades are formulated to comply with FDA 21 CFR 177.1810 (styrene block copolymers) and have been tested per the extractables methodology outlined in USP guidelines. We provide FDA-related compliance letters and extractables/leachables data upon request.
  • Q: Can your SEBS be used for direct food contact in the EU?
  • A: Selected grades comply with EU Regulation 10/2011 on plastic materials and articles intended to come into contact with food. We supply a Declaration of Conformity (DoC) and specific migration test results for the relevant food simulants. Please specify your intended food type and processing conditions so we can match you with the correct grade.
  • Q: Is ISO 10993 biocompatibility data available?
  • A: SEBS-M200 has completed a subset of ISO 10993 tests including cytotoxicity (10993-5) and sensitization (10993-10). Full test reports are available under NDA. For implantable or long-term body-contact applications, we recommend customers conduct end-product biocompatibility testing as required by their regulatory pathway.
  • Q: What sterilization methods are compatible with your medical SEBS grades?
  • A: Our medical grades are validated for gamma irradiation (25–50 kGy), ethylene oxide (EtO) gas, and steam autoclave (121 °C, 15 min). Post-sterilization mechanical properties data is available in our technical datasheets. Dry heat sterilization above 130 °C is not recommended.
  • Q: Can you supply custom-colored or pre-compounded medical SEBS?
  • A: We supply natural (water-white) pellets for downstream compounding. Pre-compounded colors using FDA/EU-approved pigments can be arranged through our qualified compounding partners. Please contact our technical sales team with your color requirements and application specifications.
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