Redefine Optimisation with eBAG 3D Mixer

transparent and square eBAG® 3D Tank (supplies) for bioprocessing equipment, has a white label on the top left side and a mixer inside the bag.

Smart liquid handling solutions in bags

Innovative and reliable single-use bag solutions for the biotech sector with eBAG 3D Mixer.

In the evolving landscape of Biotech, the single-use eBAG 3D Mixer optimize fluid dynamics for efficient mixing, save storage and easy transportation of liquids. Engineered with a unique 3D design, TECNIC eBAG 3D Mixer are reshaping the biotech sector by enhancing fluid dynamics for unparalleled quality results.

Produced under stringent aseptic conditions and subjected to comprehensive sterilization, these bags ensure high sterility and minimal contamination risk. With customizable features accommodating specific needs for size, configuration, and fittings, they seamlessly integrate into manufacturing processes.

Developed and Manufactured in the TECNIC ISO7 Clean Room, these 3D bags are constructed with high-quality materials and undergo gamma irradiation, making them ready-to-use according to the strictest pharmaceutical industry standards. Available in various sizes (50L, 100L, 200L, and 500L), these bags withstand rigorous handling, ensuring the safe containment of biopharmaceutical products. Meticulously designed to work seamlessly with TECNIC ePLUS® Mixer SU ⇀, they are manufactured to perfectly fit into the tank and adapt to the fully magnetic mixer for a secure and efficient process.

eBAG 3D Mixer for a superior solution

Sterility assurance

Convenience and efficiency is equal to less downtime

Cost-effectiveness

Various configuration options

Bag scalability

Quality assurance

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Film technology for enhanced bioprocess

Our TECNIC Film Technology is specifically engineered for high-quality. Every one of our Single-Use products distinguishes itself by its unique five-layer structure, with each layer serving a specific function to optimize the integrity, durability, longevity and the sterility of the equipment.

Layer 1 - LPDE (50μm)

Layer 2 - TIE (10μm)

Layer 3 - EVOH (20μm)

Layer 4 - TIE (10μm)

Layer 5 - ULPDE (230μm)

In-house ISO 7 cleanroom for single-use standards

The manufacturing process for our single-use bioprocessing products, such as the eBAG® 2D, 3D and SU vessel, strictly complies with the rigorous standards of an ISO 7 cleanroom This specific classification guarantees a highly controlled environment, characterized by a maximum particle count of 10,000 (≥ 0.5 μm) per cubic meter of air.

This level of control is critical for ensuring the sterility and quality of our products, as it significantly reduces the risk of microbial and particulate contamination. By adhering to these standards, we ensure that each product meets the high expectations of purity and performance required in sensitive bioprocessing applications, providing our clients with reliable and consistent biotechnological solutions.

Two people covered entirely in white clothing working in a clean room in a scientific application.

through a window, people can be seen in a single-use plant working

High standards in bioprocessing

The eBAG represents not just an innovation in cell culture film technology, but also sets new benchmarks in quality and regulatory compliance. Each eBAG is manufactured under stringent Good Manufacturing Practices (GMP), ensuring that every product meets the highest standards of quality and safety.

Sterilization is a critical aspect of production. We employ advanced radiation sterilization methods, effectively eliminating biological contaminants without compromising the product's integrity. This sterilization process is crucial for maintaining sterility and safety in sensitive applications.

Furthermore, the production of eBAG takes place in inhouse ISO 7 classified facilities. These cleanrooms are designed to control contamination and maintain an aseptic environment, essential for the manufacturing of biotechnological products. Adhering to ISO 7 standards ensures that each eBAG is produced in a controlled environment, minimizing the risk of cross-contamination and ensuring product consistency.

Together, these quality measures and regulatory compliance reflect our commitment to excellence in manufacturing eBAG, providing our clients with reliable and safe products for their critical bioprocessing applications.

Test	Requirements	Results
USP <788> Particulate Matter in Injections	Pass	Pass
USP <88> Systemic Toxicity	Pass	Pass
USP <88> Intracutaneous	Pass	Pass
USP <88> Implantation	Pass	Pass
USP <87> Cytotoxicity, Agar Diffusion	Pass	Pass
USP <87> Cytotoxicity, Elution	Pass	Pass
USP <85> Kinetic-Chromogenic LAL	0,25 EU/ml	0,006 EU/ml
USP <661.1> Physicochemical-Non Volatile	15 mg	1 mg
USP <661.1> Physicochemical-Residue on Ignition	5 mg	1 mg
USP <661.1>Physicochemical-Heavy Metals	1 ppm	1 ppm
USP ≤661.1>Physicochemical-Buffering Capacity	10 ml	1 ml
ISO 10993-4 In-Vitro Hemolysis Study	Non-haemolytic	Non-haemolytic
Irradiation Dosage	25-50 kGy	25-50 kGy
EP <3.2.2.1> Plastic Containers for Aqueous Solutions for Parenteral Infusion	Pass	Pass

The eBAG® represents not just an innovation in cell culture film technology, but also sets new benchmarks in quality and regulatory compliance. Each eBAG® is manufactured under stringent Good Manufacturing Practices (GMP), ensuring that every product meets the highest standards of quality and safety.

Furthermore, the production of eBAG® takes place in inhouse ISO 7 classified facilities. These cleanrooms are designed to control contamination and maintain an aseptic environment, essential for the manufacturing of biotechnological products. Adhering to ISO 7 standards ensures that each eBAG® is produced in a controlled environment, minimizing the risk of cross-contamination and ensuring product consistency.

Together, these quality measures and regulatory compliance reflect our commitment to excellence in manufacturing eBAG®, providing our clients with reliable and safe products for their critical bioprocessing applications.

Test	Requirements	Results
USP <788> Particulate Matter in Injections	Pass	Pass
USP <88> Systemic Toxicity	Pass	Pass
USP <88> Intracutaneous	Pass	Pass
USP <88> Implantation	Pass	Pass
USP <87> Cytotoxicity, Agar Diffusion	Pass	Pass
USP <87> Cytotoxicity, Elution	Pass	Pass
USP <85> Kinetic-Chromogenic LAL	0,25 EU/ml	0,006 EU/ml
USP <661.1> Physicochemical-Non Volatile	15 mg	1 mg
USP <661.1> Physicochemical-Residue on Ignition	5 mg	1 mg
USP <661.1>Physicochemical-Heavy Metals	1 ppm	1 ppm
USP ≤661.1>Physicochemical-Buffering Capacity	10 ml	1 ml
ISO 10993-4 In-Vitro Hemolysis Study	Non-haemolytic	Non-haemolytic
Irradiation Dosage	25-50 kGy	25-50 kGy
EP <3.2.2.1> Plastic Containers for Aqueous Solutions for Parenteral Infusion	Pass	Pass

Test	Need	Result
USP <788> Particulate Matter in Injections	Pass	Pass
USP <88> Systemic Toxicity	Pass	Pass
USP <88> Intracutaneous	Pass	Pass
USP <88> Implantation	Pass	Pass
USP <87> Cytotoxicity, Agar Diffusion	Pass	Pass
USP <87> Cytotoxicity, Elution	Pass	Pass
USP <85> Kinetic-Chromogenic LAL	0,25 EU/ml	0,006 EU/ml
USP <661.1> Physicochemical-Non Volatile	15 mg	1 mg
USP <661.1> Physicochemical-Residue on Ignition	5 mg	1 mg
USP <661.1>Physicochemical-Heavy Metals	1 ppm	1 ppm
USP ≤661.1>Physicochemical-Buffering Capacity	10 ml	1 ml
ISO 10993-4 In-Vitro Hemolysis Study	Non-haemolytic	Non-haemolytic
Irradiation Dosage	25-50 kGy	25-50 kGy
EP <3.2.2.1> Plastic Containers for Aqueous Solutions for Parenteral Infusion	Pass	Pass

Bag properties

Robust exterior layer

All of TECNIC Single-Use products are designed with a robust construction to guaranteeing the secure containment of the product. The mechanical strength of our products ensures durability and resistance to external physical factors.

Sterile environment

Temperature resilience

GMP and ISO standards

Compliance with standards

The eBAG 3D adheres to major biocompatibility and physicochemical standards, including Class VI, USP 87, ISO 10993, FDA 21CFR177, and Eu 3.1.9. Its compliance highlights its suitability for delicate bioprocessing applications.

Low extractable profile

Following Bio-Process Systems Alliance (BPSA) guidelines, the eBAG 3D features a low extractable profile, ensuring minimal material release into the product. This preserves the purity and integrity of bioprocessed materials.

Validation guide availability

A detailed validation guide for the eBAG 3D is available upon request. This guide provides comprehensive information on its performance and application suitability, serving as a vital resource for understanding the product's capabilities and compliance.

Manufacturing standards

Manufactured in an ISO14644-1 class 7 cleanroom, the eBAG 3D is produced in a controlled environment, significantly reducing contamination risks. This manufacturing standard is essential for ensuring the product's high quality and reliability.

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