Product Description:
This advanced multi-layer film is engineered to protect heat-sensitive biologic drugs (e.g., mRNA vaccines, monoclonal antibodies, and enzyme therapies) during packaging and storage. By combining PVC, PE, and PVDC, it achieves a balance of durability, flexibility, and ultra-low sealing temperatures while maintaining stringent barrier properties. Ideal for cold-chain logistics and sterile applications, it complies with FDA, USP Class VI, and ISO 10993 standards for pharmaceutical packaging.
Product Specifications
| Attribute | Details |
|---|---|
| Material Layers | PVC (outer layer), PE (sealing layer), PVDC (barrier layer) |
| Thickness Range | 0.07–0.30 mm (customizable) |
| Sealing Temperature | 80–110°C (optimized for minimal thermal exposure) |
| Oxygen Barrier | ≤1.2 ml/m²·day (at 23°C, 50% RH) |
| Moisture Barrier | ≤0.5 g/m²·day (at 38°C, 90% RH) |
| Sterilization Compatibility | Gamma irradiation, ethylene oxide (EtO), hydrogen peroxide plasma |
| Temperature Resistance | -40°C to 60°C (stable across freezing and ambient conditions) |
Key Features
Preservation of Drug Efficacy
Avoids thermal degradation by sealing at 80–110°C (vs. 130–150°C for traditional films).
PVDC layer blocks >99% oxygen and moisture, critical for biologics prone to oxidation or hydrolysis.
Regulatory Compliance
Meets FDA 21 CFR and EU Annex 1 standards for sterile drug packaging.
USP Class VI-certified for direct drug contact.
Operational Flexibility
Compatible with automated blister packaging lines and vertical form-fill-seal (VFFS) machines.
Retains flexibility even at -40°C, reducing crack risks during frozen storage.
Sustainability Features
PVC layer uses non-phthalate plasticizers (e.g., acetyl tributyl citrate) for reduced toxicity.
Recyclable PE layer (where PVDC is omitted in select formulations).
Production Process
Raw Material Preparation
PVC Resin: Mixed with stabilizers (e.g., Ca-Zn), plasticizers, and lubricants.
PE Granules: Pre-dried to ≤0.02% moisture content.
PVDC Dispersion: Coated onto PE via solvent-based or aqueous methods.
Multi-Layer Extrusion
Co-extrusion of PVC (top layer) and PE/PVDC (middle/sealing layer) at 160–190°C.
Layer thickness controlled to ±2% tolerance using laser gauges.
Calendering & Surface Treatment
Film passed through chilled rollers to set structure and enhance surface smoothness.
Corona treatment (40–50 dynes/cm) applied to improve printability and adhesion.
Slitting & Quality Assurance
Precision slitting to customer-specified widths (max 1,500 mm).
100% inline inspection for pinholes, thickness deviations, and barrier defects.
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)
Q1: Can this film replace aluminum foil in blister packaging?
Yes. Its high barrier performance allows use in foil-free blisters for biologics, reducing packaging weight by 50%.
Q2: How does it perform with biologics containing organic solvents?
The PE layer resists solvents like ethanol (≤20% concentration). For aggressive solvents, a fluoropolymer-coated variant is recommended.
Q3: Is the film suitable for lyophilized drug packaging?
Absolutely. Its low moisture permeability (<0.5 g/m²·day) protects lyophilized products from rehydration.
Q4: What is the maximum shelf life achievable?
Up to 36 months for vaccines stored at 2–8°C, validated via real-time stability studies.
Hot Tags: low-temperature sealing pvc/pe/pvdc film for heat-sensitive biologic drugs, China, manufacturers, suppliers, factory, customized, custom, wholesale, low price, free sample, Pvc Pe Pvdc Film, Pvdc Coated Pvc Film, Colorful PVC Film, Pvc Pvdc Film For Pharmaceutical Packaging, Triplex PVC PE PVDC, PVC PE PVDC Sheet For Medicine Packaging
