PVC Hard Sheet Pharmaceutical Packaging Material Registration Certificate A - Capsule and Tablet Blister Packaging

       Blister packaging for tablets and capsules is one of the core applications of PVC rigid sheets in the pharmaceutical field. Anyang Feilong Pharmaceutical produces medicinal PVC rigid sheets, designed to balance drug protection, ease of use, and safety. The following is a detailed introduction:

1. Blister Packaging Structure A typical pharmaceutical blister pack is composed of a transparent PVC rigid sheet laminated with an aluminum foil backing layer: Outer Layer (PVC Rigid Sheet): Provides transparency, support, and formability. Inner Layer (Heat-Seal Coating): Typically made of PVDC (polyvinylidene chloride) or aluminum foil to enhance barrier properties (moisture-proof, light-resistant, oxygen barrier). Backing Material: Aluminum foil or paper-plastic composite material, designed for easy tearing to access medication.

2. Advantages of PVC Rigid Sheets High Transparency: Allows for easy inspection of drug integrity (e.g., color, shape). Excellent Formability: Precise thermoforming adapts to tablet/capsule sizes, reducing movement and friction. Barrier Performance: Basic PVC sheets offer moderate water vapor barrier; lamination with PVDC or aluminum foil can reduce water vapor transmission rate to <0.5 g/m²·24h. UV-blocking additives prevent degradation of light-sensitive drugs. Safety: Complies with pharmaceutical-grade standards (e.g., USP Class VI, EU 10/2011), ensuring no migratory toxicity. High heat-seal strength (typically ≥1.5 N/15mm) prevents breakage during transportation.

3. Key Points in Production Process Material Selection: Food and pharmaceutical-grade PVC resin: vinyl chloride monomer residue ≤1 ppm. Stabilizers: Calcium-zinc stabilizers replace traditional lead salts to avoid heavy metal contamination. Composite Process: PVC rigid sheets are combined with PVDC/aluminum foil via dry lamination or extrusion coating. Aluminum foil thickness is typically 20-40μm, ensuring no pinholes (testing standard: ASTM D3985). Heat-Sealing Parameters: Heat-seal temperature: 120-150°C (adjusted based on coating type). Pressure: 0.2-0.6 MPa, ensuring uniform sealing.

4. Industry Standards and Certifications International Standards: ISO 15378: Quality management for primary packaging materials in pharmaceuticals. US FDA 21 CFR 177.2600: Safety standards for PVC materials in contact with food and drugs. Performance Testing: Seal integrity testing: Vacuum leak method (e.g., ASTM D3078). Barrier testing: Water vapor transmission rate (ASTM E96), oxygen transmission rate (ASTM D3985). Biocompatibility: Cytotoxicity testing (ISO 10993-5).