Single-Use StorageSource: 3M Purification
3M Purification Inc.’s 2D and 3D single-use biocontainers offer scalable and cost-effective sterilized, “Plug n Play” solutions for storage, transfer and process applications in the biopharmaceutical industry.
3M Purification Inc.’s 2D and 3D single-use biocontainers offer scalable and cost-effective sterilized, “Plug n Play” solutions for single-use storage, transfer and process applications in the biopharmaceutical industry. Made with a state-of-the-art co-extruded film in an ISO Class 5 cleanroom and using medical grade polymers that are free of any animal derived components. 3M Purification’s single-use biocontainers have exceptional strength, superior barrier properties and are exceptionally clean.
These single-use biocontainers have been designed to provide total fluid drainability and ease of use. The 2D and 3D biocontainers are made with the same materials of construction for easy scalability of the process from R&D to clinical manufacturing to commercial production. Since 3M Single-Use Biocontainers are 100% integrity tested as a whole bag with the connectors attached, they offer exceptional reliability. The 2D biocontainer connections are molded as a single piece to enhance the reliability even further.
Because one film is used for both the 2D and 3D single-use biocontainers, scale-up is easy and the validation burden across applications is minimized. The biocontainers are manufactured in ISO Class 5 cleanrooms while many comparable competitive products are made in ISO Class 7 cleanrooms. US FDA “Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice” recommends ISO Class 5 environment for critical areas for processing sterile drugs. A whole bag assembly integrity test is performed during the manufacturing process, which increases process reliability. The use of industry standard connectors allows easy integration with other single-use components. To ensure maximum control over product quality, 3M Single-Use Biocontainers are made in a vertically integrated supply chain. Additionally, to ensure reliability of supply, the film and bicontainers are made at multiple facilities.
Single-use biocontainers are offered in industry standard sizes with C-Flex tubing and CPC connectors to suit volume requirements. While the 2D biocontainers do not require any special devices to hold them in place, the 3D biocontainers do require matching totes.
- 2D single-use biocontainers: 1, 5, 10, 20, and 50 liters
- 3D single-use biocontainers: 100, 200, 500, and 1000 liters
- Supporting hardware: stainless steel totes