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

Engineered for pharmaceutical parenteral packaging, sterile liquid containment, and single-use bioprocess systems, this pharmaceutical-grade three-layer co-extrusion infusion film provides high seal integrity, chemical inertness, and biological safety. Supplied in standard continuous master rolls of 200 μm nominal thickness by 500 m length, this co-extruded substrate provides consistent mechanical toughness, puncture resistance, and tensile balance required for automated high-speed form-fill-seal (FFS) processing and pre-formed bag fabrication.

Styrene-Elastomer and Polyolefin Modified Polypropylene Architecture

The material platform utilizes high-purity pharmaceutical polypropylene (PP) modified through precision melt blending with specialized styrene-based block copolymer elastomers and branched polyolefin polymers. This three-layer formulation enhances flex-crack resistance, low-temperature impact strength, and elastic recovery while preserving the thermal stability and low permeability of the polypropylene matrix. The film easily withstands terminal moist-heat steam autoclaving without post-sterilization embrittlement, optical hazing, or layer delamination.

Comprehensive Global Pharmacopeial Compliance

The three-layer co-extruded film complies with stringent international biocompatibility and pharmaceutical packaging standards, satisfying USP <87> Biological Reactivity Tests (In Vitro Cytotoxicity), USP <88> Biological Reactivity Tests (In Vivo Class VI Biocompatibility), European Pharmacopoeia EP 3.1.6 (Polypropylene for containers and closures for parenteral preparations), and Chinese Pharmacopoeia standard YBB00102005-2015 alongside enterprise quality standard Q/321281GSB67-2020. The formulation contains no intentional plasticizers, heavy metals, or animal-derived components, delivering low extractables and leachables (E&L) profiles.

Versatile Formulation Packaging and Process Fluid Containment

Designed for broad chemical and formulation compatibility, this inert contact film is suited for packaging diverse large-volume parenterals (LVP), therapeutic intravenous infusions, electrolyte replacements, and active pharmaceutical solutions. Within upstream and downstream bioprocessing workflows, the film provides safe storage for sterile buffers, cell culture media, intermediate harvest pools, and bulk drug substances across ambient, refrigerated, and sub-zero storage conditions.

Technical Specifications

Frequently Asked Questions (FAQ)

1. What polymers are utilized in the formulation of this three-layer infusion film?

The core matrix is pharmaceutical-grade polypropylene blended and modified with functional styrene-based block copolymer elastomers and polyolefin materials to optimize flexibility and impact resistance.

2. What are the standard roll dimensions and thickness specifications?

The film is manufactured with a nominal thickness of 200 μm and supplied in continuous master rolls with a standard length of 500 meters.

3. What global regulatory and pharmacopeial standards does this film meet?

The film complies with USP <87> (Cytotoxicity), USP <88> (Class VI Biological Reactivity), European Pharmacopoeia EP 3.1.6, and Chinese packaging standard YBB00102005-2015.

4. How does polyolefin and styrene elastomer modification benefit polypropylene film?

The elastomer-modified blend reduces the rigidity and notch-sensitivity of pure polypropylene, significantly boosting drop-impact durability, seal toughness, and puncture resistance.

5. Can bags made from this three-layer film withstand terminal steam sterilization?

Yes, the thermal profile of the polypropylene-polyolefin blend allows finished infusion containers to undergo terminal moist-heat steam autoclaving without film distortion or delamination.

6. What sealing and bag-making technologies are compatible with this material?

The material is compatible with thermal contact hot-bar sealers, high-frequency impulse welders, and ultrasonic sealing equipment commonly utilized in medical bag manufacturing.

7. Is this film suitable for single-use bioprocess liquid storage bags?

Yes, it is designed for 2D and 3D single-use bioprocess bags used to hold cell culture media, intermediate harvest solutions, sterile process buffers, and bulk drug substances.

8. What type of drug formulations can be packaged in this infusion film?

The inert fluid-contact surface exhibits broad chemical compatibility, making it suitable for standard intravenous solutions, electrolyte therapies, glucose infusions, and sensitive therapeutic preparations.

9. How does the film perform under low-temperature cold chain storage?

The incorporated styrene-elastomer phase maintains mechanical flexibility and impact resistance during refrigerated storage (2°C to 8°C) and sub-zero storage conditions.

10. What extractables and leachables (E&L) documentation is available for regulatory filing?

The film is manufactured without plasticizers or heavy metal catalysts, generating clean E&L profiles supported by validation documentation to facilitate customer regulatory drug filings.

11. Does the film provide sufficient optical transparency for fluid inspection?

Yes, the co-extruded formulation provides optical clarity, allowing automated vision inspection systems and operators to verify liquid clarity and detect particulate contaminants.

12. Is the film formulation certified animal-derived component free (ADCF)?

Yes, all raw materials are formulated without animal-derived substances, eliminating TSE/BSE cross-contamination risks in compliance with international biopharmaceutical regulations.