5-Layer Co-Extruded Infusion Film for Bioprocess & LVP Packaging

Engineered for sterile bioprocess containers, fluid management assemblies, and large-volume parenteral (LVP) packaging, this pharmaceutical-grade five-layer co-extrusion infusion film provides high mechanical integrity, chemical inertness, and biological safety. The film is produced in a standard roll specification of 210 μm thickness by 500 m length, delivering uniform tensile strength and pinhole resistance across continuous pouch-forming and high-speed bag-making lines.

Elastomer-Modified Polypropylene Matrix

The primary structural resin consists of pharmaceutical-grade polypropylene (PP) blended with thermoplastic polyester elastomers and styrene-based block copolymer elastomers. This multi-polymer modification enhances flexibility, sub-zero impact resistance, and flex-crack resistance without compromising the thermal stability or steam sterilizability of the virgin polypropylene backbone. The resulting co-extruded composite withstands post-fill terminal moist-heat autoclaving while maintaining structural seal strength and optical clarity for visual particulate inspection.

Rigorous Pharmacopeial Compliance and Biocompatibility

The five-layer co-extrusion film satisfies global pharmaceutical regulatory standards, complying with USP <87> Biological Reactivity Tests (In Vitro Cytotoxicity), USP <88> Biological Reactivity Tests (In Vivo Class VI Plastics), European Pharmacopoeia EP 3.1.6 (Polypropylene for containers and closures for parenteral preparations), and Chinese Pharmacopoeia standard YBB00112005-2015 alongside enterprise standard Q/321281GSB63-2020. Its formulation avoids intentional animal-derived components, plasticizers, and heavy metal stabilizers, ensuring extremely low extractable and leachable (E&L) profiles.

Specialized Drug Compatibility for Large-Volume Parenterals

Engineered specifically for demanding pharmaceutical formulations, the material exhibits high compatibility with large-capacity parenteral solutions and sensitive chemical entities, including sodium bicarbonate injection. The inert contact layer resists pH shifts, active ingredient sorption, and oxidative degradation, preserving therapeutic potency throughout long-term storage across ambient, refrigerated, and cryopreservation temperatures.

Technical Specifications

Frequently Asked Questions (FAQ)

1. What primary materials are used in the formulation of this 5-layer infusion film?

The core structural matrix is pharmaceutical-grade polypropylene modified with thermoplastic polyester elastomers and styrene-based elastomers to enhance flexibility and seal toughness.

2. What are the standard dimensions and delivery specifications for this film?

The film is manufactured with a nominal thickness of 210 μm and supplied in continuous wound rolls with a standard length of 500 meters.

3. What pharmacopeial standards does this five-layer co-extrusion film meet?

The material complies with USP <87> (Cytotoxicity), USP <88> (Class VI Biological Reactivity), European Pharmacopoeia EP 3.1.6, and Chinese packaging standard YBB00112005-2015.

4. Why is this film particularly suitable for sodium bicarbonate injection?

The modified polypropylene fluid-contact layer provides high chemical inertness and low gas permeability, preventing chemical degradation and pH shifts in sodium bicarbonate solutions.

5. How does elastomer modification benefit standard polypropylene film?

Blending thermoplastic polyester and styrene elastomers overcomes the rigidity and low-temperature brittleness of pure PP, improving drop resistance and puncture strength.

6. Can bags manufactured from this film undergo terminal steam sterilization?

Yes, the thermal resistance of the polypropylene blend allows bags to undergo terminal moist-heat steam autoclaving without film deformation or delamination.

7. What sealing and welding technologies can be used with this co-extruded film?

The material is compatible with commercial thermal impulse welders, hot-bar sealers, and ultrasonic welding equipment used for bag making and tube port attachment.

8. What extractable and leachable (E&L) documentation is available?

The formulation avoids plasticizers and toxic additives, yielding low extractable profiles fully documented to support customer regulatory drug filing dossiers.

9. Can this film be used for single-use bioprocess liquid storage bags?

Yes, it is designed for single-use 2D and 3D bioprocess bags used for holding cell culture media, intermediate harvesting fluids, and sterile chromatography buffers.

10. How does the film perform under refrigerated and low-temperature storage?

The elastomer-toughened polymer matrix maintains mechanical flexibility and impact strength during refrigerated storage (2°C to 8°C) and sub-zero freeze-thaw cycles.

11. Does the film provide adequate optical clarity for visual inspection?

Yes, the refined co-extrusion process ensures optical clarity, enabling automated visual inspection systems and manual operators to inspect for particulate contamination.

12. Is the film formulation free of animal-derived components (ADCF)?

Yes, the raw materials are formulated without animal-derived substances, mitigating TSE/BSE cross-contamination risks for compliant parenteral applications.