Non pvc infusion bag film

Non-PVC infusion films are typically multi-layer co-extruded structures, often consisting of three to five layers. The outer layer is usually Polypropylene (PP) for mechanical strength and heat resistance, the middle layer acts as a gas and moisture barrier, and the inner layer is a specialized polyolefin designed for excellent biocompatibility and heat-sealing properties. Unlike PVC, these films are DEHP-free and plasticizer-free, ensuring no toxic substances leach into the medication, making them the gold standard for sensitive intravenous drugs.

Buyers must ensure suppliers comply with ISO 15747, which specifically governs plastic containers for intravenous injections. Additionally, the manufacturing facility must hold an ISO 13485 certification for medical device quality management. For market entry, verify that the product has CE marking (EU) or FDA registration (US), and request USP Class VI biological reactivity testing reports to confirm the material is safe for medical use.

High-quality Non-PVC films are designed to withstand high-pressure steam sterilization (autoclaving) at temperatures typically reaching 121°C. The film must maintain its transparency, structural integrity, and seal strength post-sterilization. It is critical to confirm the film's water vapor transmission rate (WVTR) is low enough to prevent concentration changes in the infusion liquid during its shelf life.

The film must be produced in a Class 10,000 (ISO 7) or Class 100,000 (ISO 8) cleanroom to prevent particulate contamination. Key physical benchmarks include high tensile strength, excellent puncture resistance (to prevent leaks during handling), and superior transparency to allow for easy visual inspection of the infusion fluid for particles or discoloration.

Always request a Pre-Shipment Inspection (PSI) conducted by a third-party agency like SGS or Intertek. Focus on batch consistency; ask the supplier for a Certificate of Analysis (COA) for every lot. On platforms like Made-in-China.com, prioritize Audited Suppliers who have undergone comprehensive on-site factory verifications to ensure their production capacity matches their claims.

Beyond price, negotiate on technical support and stability. Request a long-term quality guarantee agreement and clarify the shelf-life liability. For bulk orders, aim for a staged payment structure (e.g., 30% deposit, 70% after passing third-party lab testing) to ensure the supplier remains committed to the specified technical requirements.

Medical films are sensitive to environmental conditions. Ensure the shipping contract specifies temperature-controlled or moisture-proof packaging. The films should be stored in a cool, dry warehouse away from direct sunlight and chemical contaminants. Use palletized shipping to prevent mechanical damage to the film rolls, which could lead to micro-tears and compromised sterility.

Check the specific HS Code (typically under 3920 or 3921) for import duties and VAT in your country. Be aware of Anti-Dumping Duties that may apply to plastic products from certain regions. Ensure all Regulatory Affairs (RA) documentation, such as the Drug Master File (DMF) number, is provided by the supplier to facilitate smooth customs clearance and local health authority registration.