Advance your bioprocess with eBAG 2D TFF

Advanced ready-to-use single-use bags for optimization of your downstream process

eBAG 2D TFF compatible with Tangential Flow Filtration system in single-use configuration along with an special flowkit

Introducing the meticulously crafted Single-Use eBAG 2D TFF, seamlessly engineered to integrate flawlessly with TECNIC TFF systems, ensuring impeccable connections throughout the filtration process. Our innovative design caters specifically to the demands of single-use applications, providing unmatched convenience without compromising on performance.

Developed and Manufactured in TECNIC ISO7 Clean Room, these bags are built tough high-quality materials and undergo gamma irradiation. As a result, they are ready-to-use according the strictest pharmaceutical industry standards and available in various sizes (2L, 5L, 10L, 20L, 50L). The bags can be configurated according to different number of ports in order to adapt to the most specific demands.

The eBAG 2D TFF is more than just a bag; it's a solution designed with an in-depth understanding of the challenges faced in downstream processes within the biotechnology industry. Equipped with a specialized Boat Port and a Flow Kit, it empowers you to stay organized during critical processes, saving time and ensuring easy access to your tools. Safety is paramount, and our design allows for secure manipulation of your end-product.

Step into the future where convenience, functionality, and style converge in the realm of downstream biotech. Embrace innovation with eBAG 2D TFF, ensuring the preservation of the high-quality products of your bioprocess. Redefine your expectations and discover a new era in bioprocessing excellence.

Enhancing bioprocess integrity with eBAG 2D TFF

Sterility assurance
Convenience and efficiency is equal to less downtime
Various configuration options
Environmental sustainability
Scalability
Quality assurance

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)

High standards in bioprocessing

The eBAG 2D TFF 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 in-house 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® 2D TFF 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 in-house 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.

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

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
Sterile environment
Temperature resilience
GMP and ISO standards

Compliance with standards

 The eBAG 2D TFF adheres to major biocompatibility and physicochemical standards, including Class VI, USP 87, ISO 10993, FDA 21CFR177, and Eu 3.1.9. This compliance demonstrates its suitability for use in sensitive bioprocessing applications.

Low extractable profile

ollowing the guidelines of the Bio-Process Systems Alliance (BPSA), the eBAG 2D TFF has a low extractable profile, ensuring that it does not release significant quantities of materials into the product, thus maintaining the purity and integrity of the bioprocessed materials.

Validation guide availability

A complete validation guide is available upon request, providing detailed information on the eBAG 2D TFF performance and suitability for various applications. This guide is an essential resource for users to understand the product's capabilities and compliance.

Manufacturing standards

The eBAG 2D TFF is manufactured in an ISO14644-1 class 7 cleanroom, ensuring that it is produced in a controlled environment that minimizes the risk of contamination. This level of manufacturing standard is crucial for maintaining the high quality and reliability of the product.

Boat Ports in eBAG 2D

Boat ports in our Single-Use products are designed for precision and versatility. They facilitate seamless fluid transfer, allowing for the addition or removal of media and products while maintaining a sterile environment. These ports are also key for in-process sampling, enabling consistent quality monitoring without compromising bag integrity. TECNIC Bag Port is also equipped to accommodate various sensors, which provide critical data for process control. Finally, the robust design of these ports ensures durability and compatibility with a range of bioprocessing equipment, making them a vital feature in advanced biotechnological solutions.

In-house ISO 7 cleanroom for single-use standards

The manufacturing process for our single-use bioprocessing products, such as the eBAG 2D and 3D, 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.

Our sales team is ready to assist you with the most technical details.

Connect with our team today. Whether you have specific questions or are just beginning to explore, we're here to guide and assist. Reach out now and let's shape the future together.