Pharmaceutical PVC
1. Definition Pharmaceutical PVC refers to medical-grade polyvinyl chloride specially manufactured for pharmaceutical packaging and medical disposable devices. It complies with strict pharmacopoeia and packaging safety standards, and is divided into rigid pharmaceutical PVC and flexible medical PVC.
2. Two Main Types & Applications
(1) Rigid Pharmaceutical PVC (PVC-U Blister Sheet)
• Composition: High-purity virgin PVC resin with lead-free pharmaceutical-grade calcium-zinc stabilizers; no plasticizers added.
• Main use: PTP blister packaging for tablets, capsules, pills and oral solid medicines. It is heat-sealed with medicinal aluminum foil to form individual sealed cavities for drugs.
• Key properties:
1). High transparency, allowing visual inspection of intact medicines.
2). Excellent thermoformability, compatible with high-speed pharmaceutical packaging machines.
3). Good moisture resistance and stable heat-sealing performance with medicinal foil.
• Safety limits: Residual vinyl chloride monomer ≤1 ppm; heavy metal leachables, pH value and oxidizable substances meet pharmaceutical standards.
(2) Flexible Medical PVC
• Composition: PVC resin mixed with medical plasticizers. Traditional DEHP plasticizer is gradually replaced by non-phthalate plasticizers like TOTM and ATBC to reduce migration risks.
• Main use: Disposable infusion bags, blood storage bags, dialysis tubes, oxygen catheters and endotracheal tubes.
• Key properties: Soft, elastic, resistant to saline and common liquid medicines, and suitable for EO ethylene oxide low-temperature sterilization. It is the only plastic material globally approved for long-term blood storage.
Advantages
1. High chemical stability: Low extractables and low substance migration; no chemical reaction with most solid drugs and infusion liquids.
2. Cost-effective processing: Lower raw material cost than PET and PP alternatives; fast thermoforming suitable for mass pharmaceutical production lines.
3. Customizable functionality: Transparent sheets for regular medicines, tinted opaque sheets (green/black) for light-sensitive drugs to block ultraviolet light.
4. Wide sterilization compatibility: Rigid sheets support radiation sterilization; flexible medical PVC tolerates EO sterilization without material degradation.
