China Supplier: Medical Packaging Films at Factory Price

As a leading manufacturer based in Weifang, China, with 30+ years of expertise since our establishment in 1993, we specialize in the production of high-performance medical packaging films designed to meet the stringent requirements of the global healthcare industry. Located at the North Section of East Outer Ring Road, Zhucheng City, our 10,000㎡ state-of-the-art facility is equipped with cutting-edge technology, ISO-certified cleanrooms, and a dedicated team of 130 professionals. We deliver innovative, reliable, and compliant packaging solutions for medical devices, pharmaceutical products, and sterile supplies, ensuring patient safety and product integrity.  

With CNY 10 million in fixed assets and an annual output value of CNY 20 million, we combine advanced material science, rigorous quality control, and customization capabilities to serve hospitals, medical device OEMs, and pharmaceutical companies worldwide. Our medical packaging films are engineered to comply with ISO 11607, FDA, and EU MDR standards, offering unmatched barrier properties, durability, and sterilization compatibility.  

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Product Overview: Medical Packaging Films  

Medical packaging films play a critical role in protecting sensitive medical products from contamination, moisture, oxygen, and physical damage. Our films are tailored for applications such as:  

- Sterile barrier systems for surgical instruments, implants, and catheters.  

- Pharmaceutical blister packs and pouches for tablets, capsules, and injectables.  

- Tyvek®-alternative breathable films for sterilization wraps and pouches.  

- High-barrier laminates for diagnostic kits, IVD reagents, and biologics.  

Our solutions prioritize:  

- Sterilization compatibility (ethylene oxide, gamma radiation, steam autoclave, electron beam).  

- Puncture and tear resistance for sharp or heavy medical devices.  

- Transparency and printability for product visibility and regulatory labeling.  

- Sustainability with recyclable and halogen-free material options.  

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Detailed Product Parameters  

#1. Material Composition & Structures  

- Monolayer Films:  

  - PET (Polyester): 12-250µm thickness; high clarity, tensile strength, and chemical resistance.  

  - HDPE/LDPE: 50-200µm; moisture-resistant, cost-effective for non-critical applications.  

  - PP (Polypropylene): 30-150µm; autoclave-safe, ideal for liquid pouches.  

- Multi-Layer Co-Extruded Films:  

  - PET/PE/EVOH/PE: 5-7 layers; ultra-high oxygen barrier (<0.5 cm³/m²·24h·atm) for sensitive pharmaceuticals.  

  - PA/AL/PE: Aluminum foil laminates; light and moisture barrier for long-term storage.  

  - Tyvek®-PE Composites: Aseptic breathable films for sterilization pouches (pore size 0.2-0.5µm).  

- Specialty Films:  

  - Anti-Static Films: Surface resistivity ≤10¹¹ Ω/sq for electronic medical devices.  

  - High-Clarity Films: >90% transparency for visual inspection of contents.  

  - Recyclable Mono-Materials: PE or PP-based structures compatible with circular economy goals.  

#2. Functional Performance  

- Sterilization Compatibility:  

  - Ethylene Oxide (EtO): Films withstand 55°C, 60% RH, and gas penetration without delamination.  

  - Gamma Radiation: Retains integrity at 25-50 kGy doses.  

  - Steam Autoclave: Resists temperatures up to 135°C for 30 minutes.  

  - Electron Beam (E-beam): No degradation at 25-40 kGy.  

- Barrier Properties:  

  - Oxygen Transmission Rate (OTR): As low as 0.3 cm³/m²·24h·atm (EVOH-based films).  

  - Water Vapor Transmission Rate (WVTR): ≤0.1 g/m²·24h (foil laminates).  

  - Light Barrier: UV-blocking films with >99% opacity for light-sensitive drugs.  

- Mechanical Strength:  

  - Tensile Strength: ≥50 MPa (MD) and ≥45 MPa (TD) (tested per ASTM D882).  

  - Elongation at Break: ≥150% (MD/TD) for flexible packaging.  

  - Puncture Resistance: ≥15N (ASTM D1709; suitable for sharp surgical tools).  

- Sealability:  

  - Heat Seal Strength: ≥40 N/15mm (ASTM F88; peelable or permanent seal options).  

  - Cold Seal Compatibility: For temperature-sensitive biologics.  

#3. Product Formats & Customization  

- Roll Stock Films: Widths 200mm-1,500mm; lengths up to 5,000 meters.  

- Pre-Formed Pouches: Sterile pouches with self-sealing adhesive strips or Tyvek® lids.  

- Blister Films: Thermoformable PVC/PVdC, COC, or Aclar®-based structures.  

- Die-Cut Lids: Precision-cut films for trays and clamshells.  

- Custom Printing:  

  - Inks: Non-toxic, low-migration inks compliant with FDA 21 CFR and EUPIA guidelines.  

  - Printing Methods: Flexographic (up to 8 colors), rotogravure, or digital printing.  

  - Labeling: Barcodes, QR codes, LOT numbers, and sterilization indicators.  

#4. Certifications & Compliance  

- Quality Standards: ISO 13485, ISO 11607-1/2, EN 868, USP <661>.  

- Regulatory Approvals: FDA 21 CFR Part 177, EU MDR 2017/745, Japan PAL, China NMPA.  

- Sustainability: REACH, RoHS, Halogen-Free (IEC 61249-2-21), and ISO 14001.  

Manufacturing Strength & Technological Excellence  

#1. Advanced Production Infrastructure  

- Cleanroom Facilities: Class 100,000 cleanrooms for medical-grade film production.  

- Extrusion Lines: 8 multi-layer co-extrusion lines with inline thickness gauges (accuracy ±2µm).  

- Lamination & Coating: Dry-bond, solvent-free, and adhesive laminators; SiO₂ coating for barrier enhancement.  

- Slitting & Rewinding: Precision servo-controlled machines with dust-free winding.  

- Quality Testing Lab: Equipped with:  

  - OTR/WVTR testers (MOCON, ASTM F1927/F1249).  

  - Seal integrity testers (ASTM F1140).  

  - Bioburden and endotoxin testing equipment.  

#2. Quality Assurance Process  

- Raw Material Control:  

  - FDA-grade resins sourced from BASF, Dow, and Mitsui Chemical.  

  - Certificates of Analysis (CoA) for every batch.  

- In-Process Checks:  

  - Real-time monitoring of thickness, seal strength, and barrier properties.  

  - Particulate contamination checks via automated vision systems.  

- Final Product Validation:  

  - 100% leak testing (bubble emission method per ASTM D3078).  

  - Accelerated aging studies (ASTM F1980) for shelf-life validation.  

#3. R&D & Innovation  

- Material Development: Collaboration with universities and material institutes to create high-barrier, lightweight films.  

- Sustainability Initiatives: Development of recyclable mono-material films and biodegradable PLA-based alternatives.  

- Smart Packaging: Integration of RFID tags and freshness indicators for track-and-trace applications.  

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Service Advantages  

#1. End-to-End Customization  

- Design Support: CAD prototyping for custom pouch shapes, spout attachments, and tear-notches.  

- MOQ Flexibility: Low minimum order quantities from 2,000 sqm for niche medical applications.  

- Rapid Prototyping: Functional samples delivered within 5-7 working days.  

#2. Global Logistics & Delivery  

- Fast Turnaround: 20-35 days for standard orders; expedited services in 15 days.  

- Shipping Expertise: FOB Qingdao/Shanghai; DDP terms available. Partnerships with DHL, FedEx, and Maersk.  

- Inventory Management: Safety stock programs for high-demand films (e.g., Tyvek® alternatives).  

#3. After-Sales Support  

- Technical Assistance: 24/7 support for seal parameter optimization and sterilization validation.  

- Documentation: Full regulatory documentation, including DoC, CoC, and sterilization compatibility reports.  

- Training: On-site or virtual workshops on medical packaging standards and best practices.  

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Global Export Leadership  

- Export Markets: Serving 40+ countries, including the USA, Germany, India, Brazil, and Saudi Arabia.  

- Compliance Expertise:  

  - EU MDR Technical File preparation.  

  - FDA Drug Master File  (DMF) submissions.  

  - CE Marking and Health Canada licensing.  

- Sustainability Commitment:  

  - Carbon-neutral production via solar panels and waste recycling programs.  

  - Recyclable medical films aligned with Ellen MacArthur Foundation guidelines.  

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Case Study: Enhancing Sterility Assurance for Surgical Kits  

Client: A German medical device OEM requiring sterile barrier systems for orthopedic implants.  

Challenges:  

- Maintain sterility for 5 years under 25°C/60% RH storage.  

- Compatibility with EtO and gamma sterilization.  

- Peelable seals without fiber tear.  

Solution:  

- Developed a 3-layer PET/PE/EVOH film with anti-static coating.  

- Integrated a Tyvek®-like breathable lidstock with 0.3µm pore size.  

- Achieved ISO 11607 certification and 0% seal failure rate in validation.  

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Why Choose Us?  

1. Three Decades of Trust: Partnered with Fortune 500 healthcare brands like Johnson & Johnson and Cardinal Health.  

2. Cost Efficiency: 20-30% cost savings vs. European suppliers, with equivalent quality.  

3. Regulatory Mastery: In-house team for global compliance, reducing client time-to-market.  

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Contact Information  

Factory Address: Dongwaihuan Road, Weifang City, Shandong Province, China

Email: zhugeorge158@gmail.com  

WhatsApp: +86 15853635022 

Website: https://www.huasupackaging.com/ 

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Your Strategic Partner in Medical Packaging Innovation – Ensuring Safety, Compliance, and Reliability Since 1993