Ami Polymer launches IMAFLEXELL™ Film for bioprocessing applications

Overview

• Post By : Suresh Rathod


• Source: Microbioz India


• Date: 08 Dec,2025

In today’s rapidly evolving bioprocessing landscape, maintaining uncompromised sterility, safety, and performance has become more critical than ever. Addressing these demands, Ami Polymer Pvt. Ltd. introduces IMAFLEXELL™ Film, a next-generation multi-layer barrier film engineered to elevate the reliability of single-use bioprocessing systems.

What Makes IMAFLEXELL™ Film Unique

Ami Polymer Pvt Ltd. has engineered Imaflexell™ Film, a next-generation multi-layer barrier film, to redefine safety, reliability, and performance in bioprocessing applications. Designed and produced in an ISO 9001 and ISO 15378 certified cleanroom, the film delivers superior barrier and mechanical properties essential for critical biopharmaceutical processes. At the core of its innovation lies a five-layer co-extruded structure that provides unmatched balance between flexibility, strength, and barrier protection:

This advanced 320 µm film composition ensures low gas permeability, high puncture resistance, and exceptional chemical compatibility, making it ideal for demanding liquid-handling systems.

Why It Matters

In bioprocessing, maintaining sterility and chemical stability of sensitive media is critical. Imaflexell™ Film directly addresses key challenges faced in single-use technologies (SUT):

1. Superior Barrier Properties: EVOH core layer provides exceptional resistance to oxygen, carbon dioxide, and moisture—preserving product integrity and extending shelf life.
2. Mechanical Resilience: High tensile strength (up to 15 MPa) and elongation (>500%) ensure durability even under stress and cold conditions (below -60°C).
3. Low Extractable and Leachable: Extensive BPOG and ICH Q3D-compliant extractable studies confirm no detectable volatile, semi-volatile, or non-volatile organic compounds.
4. Biocompatibility and Safety: Fully compliant with USP <85>, <87>, <88>, <661> and ISO 10993 series.
5. Tests confirm non-cytotoxic, non-haemolytic, non-irritant, and non-sensitizing characteristics.
6. Gamma Sterilization Compatible: Stable across 25–40 kGy irradiation range without degradation in clarity, strength, or barrier performance.

By combining scientific precision with regulatory assurance, Imaflexell™ Film minimizes process risks and ensures biopharmaceutical consistency from development to commercial scale.

Applications across Bioprocessing

Imaflexell™ Film’s versatility allows seamless integration across the entire single-use workflow — from 50 mL lab-scale bags to 2000 L production-scale systems. Its configurations include:

1. 2D Pillow-Style Bags: Ideal for small-volume storage and sampling.
2. 3D Cube-Style Bags: Designed for large-scale liquid storage, media preparation, and buffer handling.
3. Custom Assemblies: Available with porting, connectors, and manifolds for specific process needs.

Typical Applications

1. Media and buffer storage
2. Intermediate product collection
3. Aseptic transfer and sampling
4. Bioreactor and mixing bag assemblies
5. Cell culture and fermentation processes

Each film configuration is pre-irradiated and ready to use, ensuring sterility and convenience for GMP environments.

Certifications & Quality Assurance

Imaflexell™ Film is validated under stringent regulatory and quality standards to meet global biopharmaceutical expectations.

Regulatory Compliance Includes:

1. USP Standards: <85>, <87>, <88> (Class VI), <661>, <788>
2. ISO Standards: 10993-4, 10993-5, 10993-10, 10993-23, 11137-1
3. ASTM Tests: D882 (Tensile), D3985 (O₂ Transmission), F1249 (Water Vapour), F2476 (CO₂ Transmission), D1003 (Transparency)
4. ICH Q3D (R2): Elemental Impurities
5. BPOG: Extractable and leachable compliance

Additional Approvals:

1. FDA 21 CFR 177.1520
2. REACH & RoHS compliant
3. BPA-free, Phthalate-free
4. No TSE/BSE risk (no animal-derived components)

Each roll undergoes traceable labelling, double-bag packaging, and gamma-validated sterility assurance, ensuring full compliance for pharmaceutical and biologics manufacturing.

Key Product Features at a Glance

Authored By: Suresh Rathod
Designation: Assistant Manager – Business Development