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

Convenience and efficiency is equal to less downtime
Cost-effectiveness
Various configuration options
Bag 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  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

Robust exterior layer
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.

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.