System for secure bioprocess material storage

eBAG 2D Storage is a ready-to-use fungible equipment

Innovating biotech storage with maximum functionality with eBAG 2D Storage

In the evolving biotech landscape, the innovative Single-Use eBAG 2D Storage will enhance your bioprocessing efforts with redefined functionality, style, durability and convenience. Designed for storage and compatible with TECNIC equipment, this biotech solution will streamline your bioprocessing operations.

Crafted in the TECNIC ISO7 Clean Room, these bags boast resilience with high-quality materials and undergo gamma irradiation, meeting the strictest pharmaceutical industry standards. Available in various sizes (2L, 5L, 10L, 20L, 50L), eBAG 2D Storage is not just a storage solution; it's a testament to precision and understanding of the challenges faced in everyday biotechnological practices.

Designed with specialized Boat Ports, eBAG 2D Storage ensures organizational efficiency during critical experiments, saving time and ensuring easy access to your tools.

Discover how convenience, functionality, and style are redefined in the world of biotech. Embrace the future with eBAG 2D Storage to elevate your bioprocess endeavors to new heights.

eBAG 2D Storage outperforms traditional storage

Sterility assurance

Configurability

Cost-effectiveness

Environmental sustainability

Scalability

Quality assurance

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Film technology for enhanced bioprocess bags

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)

Layer 1 - LPDE (50μm)

The first layer is made of Low-Density Polyethylene (LPDE) provides the Single-Use products with a robust mechanical strength, ensuring durability and resistance to physical factors. Is the outer shell that protects the bag from external factors and handling damages.

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

Compliance with standards

The eBAG 2D Storage 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

Following the guidelines of the Bio-Process Systems Alliance (BPSA), the eBAG 2D Storage 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 Storage 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 Storage 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.

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

Sterile environment

Temperature Resilience

GMP and ISO standards

eBAG® 2D TFF filled with a turquoise colored liquid, on the bag you can see a TECNIC sticker.

Boat Ports in eBAG 2D Storage

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.

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.

More information ⇀

eBAG 2D Storage is a ready-to-use fungible equipment

Innovating biotech storage with maximum functionality with eBAG 2D Storage

eBAG 2D Storage outperforms traditional storage

Sterility assurance

Configurability

Cost-effectiveness

Environmental sustainability

Scalability

Quality assurance

Download technical details ⇀

Film technology for enhanced bioprocess bags

Layer 1 - LPDE (50μm)

Layer 2 - TIE (10μm)

Layer 3 - EVOH (20μm)

Layer 4 - TIE (10μm)

Layer 5 - ULPDE (230μm)

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

Compliance with standards

Low extractable profile

Validation guide availability

Manufacturing standards

High standards in bioprocessing

Bag properties

Robust exterior layer

Sterile environment

Temperature Resilience

GMP and ISO standards

Boat Ports in eBAG 2D Storage

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

Applications

Company

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