Product Description:
Cold Form PVC PE PVDC Film for Medical Blister Protection
Multi-Layer Structure:
PVC Layer: Provides rigidity and cold-formability at room temperature.
PE Layer: Enhances flexibility and impact resistance.
PVDC Layer: Ensures superior oxygen (<10 cc/m²/day) and moisture barrier (<0.5 g/m²/day).
Key Advantages:
Cold-Forming Capability: Eliminates heat during blister shaping, reducing thermal stress on sensitive contents.
Enhanced Puncture Resistance: Withstands >50 N puncture force (ASTM F1306), minimizing damage during handling.
Chemical Inertness: Resists acids, alkalis, and organic solvents.
Transparency: Allows visual inspection of packaged items.
Regulatory Compliance: Meets FDA 21 CFR, EU MDR, and ISO 15378 standards.
Applications:
Sterile medical devices (e.g., syringes, implants).
Lyophilized drugs and biologics.
High-value diagnostic tools.
Production Process
Material Preparation:
PVC, PE, and PVDC resins are compounded with stabilizers (e.g., organotin for PVC) and slip agents.
PVDC is pre-coated onto PE via solvent-free dispersion.
Co-Extrusion & Lamination:
Layers are co-extruded using a multi-manifold die, followed by chill-roll cooling to stabilize the structure.
PVDC barrier layer is precision-laminated under controlled tension.
Cold-Forming Process:
Cold Form PVC PE PVDC Film for Medical Blister Protection is fed into a cold-forming press, where blisters are shaped at ambient temperature using high-pressure dies (up to 300 MPa).
No heat is applied, preserving drug stability.
Slitting & Winding:
Film is slit to customer-specified widths (150–600 mm) and wound on anti-static cores.
Quality Control
Puncture Resistance: Tested via ASTM F1306 using a 2.5 mm probe.
Barrier Performance: Measured with MOCON® oxygen and water vapor analyzers.
Seal Integrity: Validated by dye penetration tests (ASTM D3078).
Thickness Uniformity: Laser gauges ensure ±0.003 mm tolerance.
Sterilization Compatibility: Gamma irradiation (25 kGy) and ethylene oxide (EtO) resistance tested.
Production Facility & Cleanroom Standards
Class ISO 7 Cleanrooms: Manufactured in controlled environments with HEPA filtration and <20 particles/ft³ (≥0.5 µm).
Temperature/Humidity Control: 20–24°C, 40–60% RH to prevent film warping.
Equipment: BOBST cold-forming machines, Windmöller & Hölscher extruders.
Frequently Asked Questions (FAQ)
Q: Can this Cold Form PVC PE PVDC Film for Medical Blister Protection replace aluminum in blister packaging?
A: Partially. While it offers superior puncture resistance, aluminum foil is still required for full light and gas barrier in some cases.
Q: Is the film compatible with peelable lidding foils?
A: Yes. It works with PET/Alu or paper-based lidding materials for easy patient access.
Q: What is the minimum order quantity (MOQ)?
A: MOQ is 1,000 linear meters, with custom widths and thicknesses available.
Q: How does cold-forming affect production speed?
A: Speeds are slightly slower than thermoforming (max 200 cycles/min) but ensure zero thermal degradation.
Q: Are eco-friendly alternatives available?
A: We offer a bio-based PE variant, reducing fossil fuel dependency by 30%.
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