Ami Polymer Pvt. Ltd. has introduced IMAFLEXELL™ Film, an advanced five-layer barrier film engineered to deliver superior safety, reliability, and performance for modern bioprocessing systems. Developed in certified cleanroom facilities, the film combines mechanical strength, ultra-low extractables, and world-class regulatory compliance setting a new standard for single-use bioprocessing technologies.
What makes IMAFLEXELL™ Film a breakthrough for the bioprocessing industry?
The biopharmaceutical sector continues to shift toward flexible, contamination-free, and scalable production systems, and with this shift comes a demand for materials that deliver uncompromised purity and reliability. IMAFLEXELL™ Film, introduced by Ami Polymer Pvt. Ltd., is designed specifically to meet these evolving requirements. Engineered in ISO 9001 and ISO 15378 certified cleanrooms, the film brings a new level of precision to single-use technology (SUT), ensuring greater process safety and sterility across applications.
How is the film engineered to deliver superior protection?
At the core of its innovation lies a sophisticated five-layer co-extruded structure, engineered to balance strength, flexibility, and barrier performance. The outer LDPE layer provides mechanical durability and abrasion resistance, while two adhesive tie layers integrate the structure seamlessly. The central EVOH core—renowned for its outstanding gas-barrier capability—protects sensitive biologics from oxygen, carbon dioxide, and moisture ingress. The final inner ULDPE contact layer ensures chemical compatibility with buffers, media, and complex biologic formulations. Combined, these layers form a robust 320 µm film that offers ultra-low gas transmission, high puncture resistance, and dependable performance under extreme low-temperature conditions.
Why is this film important for modern single-use workflows?
Bioprocessing applications depend on materials that preserve sterility, ensure product stability, and withstand mechanical stress during use. IMAFLEXELL™ Film meets these needs by offering tensile strength between 13–15 MPa and elongation exceeding 500 percent—parameters crucial for handling, storage, and transport. Additionally, the film undergoes extensive extractable and leachable analysis following BPOG and ICH Q3D protocols, confirming the absence of volatile, semi-volatile, and non-volatile impurities. This directly reduces contamination risks and enhances regulatory approval pathways for biologics manufacturers.
How does the film meet global biocompatibility and safety standards?
Safety is a defining strength of IMAFLEXELL™ Film. It complies with major international standards such as USP <85>, <87>, <88> (Class VI), <661> and ISO 10993 for cytotoxicity, sensitization, and irritation. This assures manufacturers that the film is biologically safe for direct contact with process fluids. Moreover, its compatibility with gamma sterilization from 25–40 kGy ensures stable performance after irradiation—free from degradation in clarity, barrier strength, or mechanical integrity.
Where can IMAFLEXELL™ Film be used in bioprocessing?
Its versatile structure supports a wide range of formats across upstream and downstream workflows. These include 2D pillow-style bags for small-volume sampling, 3D cube-style bags for large-scale media and buffer handling, and various custom assemblies designed with specialized connectors, ports, and manifolds. The film’s integrity under pressure and temperature fluctuations makes it suitable for media preparation, aseptic transfer, intermediate product storage, bioreactor mixing, fermentation, and other critical operations.
What assurances does the product offer in terms of compliance and quality control?
Every roll of IMAFLEXELL™ Film is supported by a comprehensive regulatory package, including FDA 21 CFR 177.1520 compliance, REACH and RoHS adherence, BPA-free and phthalate-free confirmation, and assurance of no TSE/BSE risk due to the absence of animal-derived components. Traceable labeling, double-bag packaging, and validated sterility assurance further reinforce readiness for GMP environments.
What does this mean for the future of single-use systems?
By combining innovation in material science with stringent regulatory alignment, IMAFLEXELL™ Film represents a major advancement in single-use technologies. It strengthens confidence in bioprocessing operations and supports safer, faster, and more efficient development of life-saving therapeutics.
Written By: Suresh Rathod
Designation: Assistant Manager – Business Development
For more information :
www.amipolymer.com
