Single-use assemblies (SUAs) are widely used in the biopharmaceutical industry due to their advantages in reducing the risk of cross-contamination, enhancing production flexibility, and shortening batch changeover times. Since these assemblies come into direct or indirect contact with pharmaceutical products, their quality and safety are directly linked to the final drug quality and patient safety. Therefore, single-use assemblies employed in biopharmaceutical applications must meet a series of rigorous and comprehensive requirements spanning material, physical, chemical, biological, and regulatory aspects.

Amerigo Scientific provides high-quality and improved single-use assemblies to meet diverse biopharma process needs. The facility has ISO9001, ISO15378, and GMP certifications. The entire production process complies with GMP standards. Our products have completed the DMF filing and can be applied in the production and processing of large-molecule biological products, vaccines, cell and gene therapies, etc. Our comprehensive solutions feature single-use technologies for specific process steps including cell culture, formulation and filling, preparation and storage, and fluid management.

Cell Culture Solutions

Amerigo Scientific offers single-use cell culture bags and single-use bioreactor bags specifically designed for cell therapy manufacture, cell expansion in antibody production, vaccine production, and the preparation of viral vectors. In addition, our single-use fermentation bags specially designed for high-density fermentation of microorganisms such as Escherichia coli, Pseudomonas, and yeast.

Filling Solutions

The single-use filling system is a sterile transfer tool that has been pre-verified, pre-installed, and pre-sterilized. A system is formed by combining the single-use assemblies (such as hoses, filters, bags, and filling needles) and the filling unit on an equipment. Amerigo Scientific offers the single-use products that can be flexibly applied in the preparation, sterilization filtration, or filling of pharmaceutical semi-finished products of biological drugs such as vaccines, antibodies, antibody-drug conjugates (ADCs), and recombinant proteins.

Product Features

• Modular sterile and ready-to-use consumables with simple installation procedures
• Utilizing high-performance and highly transparent membrane materials
• Inverted trapezoidal design of the bag body, minimizing residue
• Possessing a high compatibility with the filling equipment and reliable filling accuracy

Liquid Mixing and Storage Solutions

Amerigo Scientific offers single-use solutions for liquid preparation, storage, and aseptic transportation required in bioprocesses, meeting specification requirements ranging from 5ml to 3000L, as well as customized design.

Fluid Management Solutions

We offer disposable sterile sampling bags that are designed for sampling during processes such as cell culture and medium preparation, making the sampling process safe and reducing material loss and repetitive operations. In addition, we also provide high-quality single-use assemblies for cryogenic storage. Our lyophilization trays are made of lightweight and breathable materials, and are compatible with most freeze-drying processes.

Product Materials and Testing Standards

Biopharmaceutical Membranes

The main raw materials of our single-use assembly products are multi-layer polymer biopharmaceutical membranes. The inner fluid-contacting layer of the biopharmaceutical membranes IX9101 and T2101 is made of ultra-low density polyethylene (ULDPE), which is animal-derived ingredient-free (ADCF) and has excellent chemical compatibility, biological safety, and low leachability. The inner surface layer material of the biopharmaceutical membrane 1400C is ethylene-vinyl acetate copolymer (EVA), a lightweight, soft, elastic and durable polymer material with good waterproof, anti-chemical corrosion, low-temperature resistance, and non-toxic properties. The middle layer material is ethylene-vinyl alcohol (EVOH) copolymer, which can effectively block oxygen, carbon dioxide, and water vapor. The non-contact outer layer material is linear low-density polyethylene (LLDPE), polyamide (PA), or polyethylene (PE), providing high mechanical strength and biological inertness.

Biopharmaceutical Membrane IX9101 is used to manufacture single-use cell culture bags, single-use bioreactor bags, and single-use filling systems. This membrane is a five-layer co-extruded film with a total thickness of 0.32mm, featuring good flexibility and transparency, excellent biological compatibility, chemical compatibility, etc.

Biopharmaceutical Membrane T2101 is used to manufacture single-use mixing bags, single-use 2D liquid storage bags, and single-use 3D liquid storage bags. It is composed of five layers, with a total thickness of 0.36mm, having excellent mechanical strength and toughness, enabling the assemblies to have properties such as wear resistance, puncture resistance, and bending resistance.

Biopharmaceutical Membrane 1400C is used to manufacture single-use 2D liquid storage bags and single-use 3D liquid storage bags. This membrane is a five-layer co-extruded film with a total thickness of 0.31mm, featuring high flexibility, low-temperature resistance, and other characteristics.

Material Characteristics

• LLDPE has high transparency and excellent flexibility, which can enhance the processing performance of the membrane.
• EVOH has high barrier properties, providing good water and gas barrier capabilities.
• EVA has excellent low-temperature resistance and anti-stress cracking ability.
• PA can enhance the physical properties of the membrane.
• ULDPE has high inertness and low leachability, and is suitable for direct contact with biological liquids and pharmaceutical materials.

Product Testing Standards