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
Effortlessly customize the eBAG 2D TFF to suit various volumes by selecting the desired number of ports. The default design includes essential features such as an inlet port, exhaust filter, feed/harvest port, and the retentate port, offering unparalleled flexibility to meet specific operational requirements.
Choose from a range of connectors and tubing options, including Quick Couplers, Tri-Clamp (TC), Aseptic Connectors, C-Flex 374, and Luer Connectors, ensuring seamless integration and compatibility with your unique setup. Elevate your operational efficiency with the versatility that comes with these varied configuration choices.
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.
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.
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
- > 25 kGy, not validated sterile
- Professional option with validated sterilization and a 2-year shelf life
This flexibility in sterilization options ensures that all our products can meet diverse sterility requirements of our customers.
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.