Pharmaceutical PVC/PVDC/PE Film for Blister

Pharmaceutical PVC/PVDC/PE composite film is a high-quality multi-layer packaging material, specifically designed for blister packaging, suppositories, and moisture-sensitive drugs. The film is composed of Polyvinyl Chloride (PVC), Polyvinylidene Chloride (PVDC), and Polyethylene (PE), offering excellent barrier properties that effectively block oxygen, moisture, and external contaminants, ensuring the stability of the drug's efficacy and shelf life.

Pharmaceutical PVC/PVDC/PE film is an advanced composite material designed for blister packaging, providing outstanding protection and functionality for sensitive drugs. Its three-layer structure combines the thermoformability of PVC, the softening and molding enhancement of PE, and the exceptional barrier performance of PVDC, ensuring that sensitive drugs are protected throughout the distribution and storage process.

Pharmaceutical PVC/PVDC/PE Film Structure and Composition

Three-layer composite: The film typically consists of three layers:

PVC Film (Polyvinyl Chloride)

This is the most basic layer. It is selected for its excellent thermoformability and inherent rigidity. In pharmaceutical applications (often referred to as rigid PVC or RPVC), it is free of plasticizers, providing necessary structural strength while protecting the dosage form.

PE Film (Polyethylene)

The middle polyethylene layer enhances overall formability, especially for deep-draw or complex blister cavities. The PE layer acts as a "buffer layer" between the rigid PVC and the barrier layer, ensuring a more uniform and defect-free thermoforming process.

PVDC Film (Polyvinylidene Chloride)

The outermost coating is made of PVDC, a polymer renowned for its exceptional moisture and gas barrier properties. The PVDC layer significantly reduces the permeability of water vapor, oxygen, and even odors, thus extending the shelf life and stability of packaged pharmaceuticals. Typically, the PVDC coating is applied in weight increments (e.g., 40, 60, 90, or 120 g/m²), allowing manufacturers to customize the barrier performance based on specific product needs.

For example, a three-layer film configuration such as "250 microns PVC / 25 microns PE / 60-120 g/m² PVDC" is commonly used to ensure sufficient barrier protection while maintaining good formability and transparency.

PVC/PVDC/PE Film Technical Specifications

PVC/PVDC/PE Film Performance Advantages

PVC/PVDC/PE Film Applications

Pharmaceutical PVC/PVDC/PE film is a high-performance, cost-effective blister packaging solution that meets the strict requirements of the pharmaceutical industry. Its three-layer structure combines the thermoformability of PVC, the softening and molding-enhancing properties of PE, and the excellent barrier properties of PVDC, ensuring that sensitive drugs are protected throughout the distribution and storage process. With its customizable specifications and outstanding performance in barrier properties and processing efficiency, this composite film is the preferred choice for pharmaceutical packaging.

• Tablets and Capsules: Its excellent barrier properties ensure that sensitive drugs are protected from moisture and oxygen, maintaining their efficacy and shelf life.
• Suppositories and Other Dosage Forms: The film's versatility extends to packaging other dosage forms that require protection from environmental factors.
• Specialized Packaging Solutions: Manufacturers can also use this film to develop calendar packaging, compliance packaging, or other innovative packaging designs that require reliable protection and clear visibility of the product.
• Pharmaceuticals: Suitable for moisture-sensitive drugs (e.g., enzyme-based drugs, anti-diabetic tablets) and products that need an extended shelf life.
• Medical Devices: Due to its high barrier properties, it can be used for suppository packaging and inhalation devices.
• Tropical Regions: Provides enhanced protection in high humidity environments.

PVC/PVDC/PE Film Superior to Other Solutions

• Cost-Effective: More economical than cold-formed aluminum blister packaging, while offering the same barrier performance.
• Regulatory Compliance: Complies with US FDA, European Pharmacopoeia, and ISO 9001/14001 standards, ensuring the safety of direct contact with drugs.
• Sustainability: Some products contain PE layers that are recyclable, in line with environmental initiatives.

PVC/PVDC/PE Film Production Process

A. Lamination and Forming

Calendering and Extrusion:

The PVC layer is typically produced through extrusion or calendering processes, which allow for the production of films with controlled thickness—usually between 200–250 microns. The rigidity of plasticizer-free PVC is crucial for maintaining the physical integrity of the blister cavity.

PE Lamination:

In a subsequent step, a thin layer of PE (usually 25–30 microns thick) is laminated onto the PVC substrate. This step is performed under controlled temperature and pressure conditions to ensure strong adhesion while preserving the thermoforming performance of the film.

PVDC Coating:

The final step involves coating the PE layer with PVDC. Using an emulsion process, an aqueous dispersion of PVDC resin is uniformly deposited onto the substrate. The film is then passed through a drying stage to remove moisture and form a uniform, continuous barrier layer on the surface. By adjusting the coating weight (measured in grams per square meter), manufacturers can control WVTR (Water Vapor Transmission Rate) and OTR (Oxygen Transmission Rate) to meet specific product protection requirements.

B. Quality Control and Post-Processing

After lamination and coating processes, the film must be inspected for uniformity, adhesion, and barrier performance. Typical quality checks include:

• Thickness Uniformity: Ensures each layer meets precise specifications.
• Barrier Property Testing: WVTR and OTR are measured using standard methods (such as ASTM F 1249 or USP tests) to confirm barrier performance meets pharmaceutical requirements.
• Surface Appearance: Evaluates the film’s transparency and gloss, both crucial for product protection and consumer appeal.

Production and Quality Control

• Advanced calendering and coating technologies are used under GMP-compliant conditions.
• Rigorous testing includes oxygen/moisture permeability, tensile strength, and dimensional stability.

Selection Recommendations

• ‌High Barrier Requirements‌: Prioritize composite films with PVDC coating ≥90 g/m².
• ‌Transparency Requirements‌: Use pure PVC/PVDC structures, avoiding the addition of opacifiers.
• ‌Sterilization Method‌: For products requiring moist heat sterilization, verify the high-temperature resistance of the PVDC layer.

Pharmaceutical-grade PVC/PVDC/PE film is a versatile and reliable blister packaging solution that balances barrier performance, formability, and regulatory compliance. Its layered structure and customization options make it an essential choice for protecting sensitive medications under various climatic conditions.