Product Description:
Thermoformable PVC/PVDC Film is a cutting-edge pharmaceutical packaging material engineered to meet the stringent requirements of modern drug blister packaging. Combining the flexibility of PVC (Polyvinyl Chloride) with the ultra-high barrier properties of PVDC (Polyvinylidene Chloride), this film ensures robust protection against moisture, oxygen, light, and microbial contamination. It is widely used for packaging tablets, capsules, lozenges, and other solid-dose medications requiring extended shelf life and compliance with global pharmaceutical regulations.
2. Key Features & Technical Specifications
2.1 Material Structure
Base Layer: Rigid PVC (200–250 microns) – Provides structural integrity and thermoforming capability.
Barrier Layer: PVDC coating (10–20 microns) – Offers exceptional gas and moisture resistance.
Optional Print-Ready Layer: Surface-treated for high-resolution printing (e.g., batch codes, branding).
2.2 Performance Characteristics
Thermoforming Temperature Range: 120–160°C (optimized for blister cavity molding).
Moisture Barrier (WVTR): ≤0.03 g/m²/day at 38°C/90% RH (ASTM F1249).
Oxygen Barrier (OTR): ≤0.5 cm³/m²/day at 23°C/50% RH (ASTM D3985).
Tensile Strength: ≥20 MPa (ASTM D882).
Elongation at Break: ≥150% (ASTM D882).
Heat Seal Strength: ≥6 N/15mm (with aluminum lidding foil, ASTM F88).
2.3 Regulatory Compliance
USP Class VI (Biological Reactivity Testing).
EU Regulation 10/2011 (Food Contact Materials).
FDA 21 CFR 177.1520 (PVC compliance) & 21 CFR 177.1630 (PVDC compliance).
ISO 15378 (Primary Packaging Materials for Medicinal Products).
REACH & RoHS (Free of phthalates, heavy metals, and SVHCs).
Q1: How does PVDC compare to other barrier coatings (e.g., PVdC, EVOH)?
A: PVDC offers superior moisture resistance vs. EVOH and better thermal stability than PVdC.
Q2: Can the film be used with cold-forming machines?
A: Yes, but thermoforming is recommended for optimal blister shape definition.
Q3: What is the carbon footprint of PVC/PVDC film?
A: Our film uses 30% recycled PVC content; PVDC layer is optimized for minimal material usage.
Q4: How to handle film brittleness in cold environments?
A: Store at >15°C; pre-warm rolls to 25°C before thermoforming.
Q5: Are there alternatives for PVDC in eco-friendly packaging?
A: We offer PVC/PE-based films with recycled content, but barrier performance may vary.
3. Production Process (Step-by-Step)
3.1 Raw Material Sourcing
PVC Resin: Medical-grade, non-plasticized, sourced from ISO 9001-certified suppliers.
PVDC Granules: High-purity copolymer with chlorine content ≥80% for optimal barrier performance.
3.2 Co-Extrusion & Lamination
Material Blending: PVC and PVDC are pre-dried to remove moisture (≤0.1% humidity).
Multi-Layer Extrusion:
Layer 1: PVC melt extruded through a T-die.
Layer 2: PVDC applied via precision slot-die coating.
Process temperature: 180–200°C.
Cooling & Calendering: Film is cooled on chill rolls (10–15°C) to ensure uniform thickness (±2% tolerance).
3.3 Surface Treatment
Corona Treatment: 40–50 dynes/cm surface energy for enhanced adhesion to inks and lidding foils.
Anti-Fog Coating (Optional): Prevents condensation in high-humidity environments.
3.4 Slitting & Winding
Film slit into rolls (standard widths: 300mm, 600mm; custom widths available).
Wound on 3" or 6" plastic cores with edge protection to prevent damage.
3.5 Batch Coding & Traceability
Laser-etched batch codes on roll edges for full traceability (ISO 9001 requirements).
Frequently Asked Questions (FAQ)
Q1: How does PVDC compare to other barrier coatings (e.g., PVdC, EVOH)?
A: PVDC offers superior moisture resistance vs. EVOH and better thermal stability than PVdC.
Q2: Can the film be used with cold-forming machines?
A: Yes, but thermoforming is recommended for optimal blister shape definition.
Q3: How to handle film brittleness in cold environments?
A: Store at >15°C; pre-warm rolls to 25°C before thermoforming.
Q4: Are there alternatives for PVDC in eco-friendly packaging?
A: We offer PVC/PE-based films with recycled content, but barrier performance may vary.
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