Experience the difference with eBAG 3D Open
Unique and innovative single-use open bag for a versatile and efficient uses
Effortless mixing and secure storage in bioprocessing with eBAG 3D Open
Introducing the single-use eBAG 3D Open, designed for effortless and efficient mixing with its unique 3D configuration, allowing users to work with unparalleled ease. Crafted from pharmaceutical-grade materials, this bag not only maintains the integrity of biologics but also resists chemical degradation, offering a perfect blend of functionality, style, durability, and convenience.
The distinctive feature of a large open port in the upper part provides diverse options for media preparation or storage systems in various atmospheric conditions. Tailored with customizable features, these bags cater to specific needs in terms of size, configuration, and fittings, ensuring seamless integration into manufacturing processes.
Developed and manufactured within the TECNIC ISO7 Clean Room, these 3D bags are constructed with high-quality materials and undergo gamma irradiation. This meticulous process ensures they are ready-to-use, available in sizes ranging from 50L to 500L, and capable of withstanding rigorous handling for the secure containment of biopharmaceutical products. The bags are designed for user-friendly operation, featuring clear markings and ergonomic handles, allowing for easy connection to existing systems and seamless integration into manufacturing processes. Experience the next level of efficiency and reliability with the Single-Use eBAG 3D Open.
Maximizing productivity with tailored single-use storage
Effortlessly tailor the eBAG 3D Open to accommodate diverse volumes by selecting the preferred number of ports. Our standard configuration options offer flexibility in terms of the number of ports, locations, and types, ranging from 2 ports to 3 ports. Each bag includes a big open port fot media components addition along with a harvest ports. Furthermore, a side sampling port can be added.
Explore a spectrum of connectors and tubing options, such as Quick Couplers, Tri-Clamp (TC), Aseptic Connectors, C-Flex 374, and Luer Connectors. These choices ensure seamless integration, providing compatibility with your unique setup.
Different additional accessories are available to adapt this bag to the most demands of you process such as an external agitation, additional inlet or outlet port or a pressure sensor in order to read the values and control the pressure before the filtration. Elevate your operational efficiency by embracing the versatility offered through these diverse 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 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.
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.
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 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.