2D Bioprocessing Bags for Single-Use Biomanufacturing

We offer standard sizes from 150 mL to 50 liters. Common volumes include 150 mL, 250 mL, 500 mL, 1L, 2L, 5L, 10L, 20L, and 50L. Custom volumes between 100 mL and 100+ liters can be manufactured to your specifications with minimum order quantities typically starting at 100-500 bags depending on configuration.

2D bags are excellent for cell culture media preparation, storage, and transport, but are not designed for active cell cultivation. For growing cells, we recommend our 3D bioprocess bags which are engineered for optimal oxygen transfer and are compatible with bioreactor platforms. Use 2D bags for mixing powdered media, preparing buffers, storing prepared media, and transporting cell culture materials.

All our 2D bioprocess bags are sterilized by gamma irradiation (25-50 kGy) in accordance with ISO 11137 standards. Gamma sterilization provides a Sterility Assurance Level (SAL) of 10⁻⁶ and does not leave any chemical residues. Each lot includes a gamma sterilization certificate with dose mapping data. The bags arrive ready to use with no additional sterilization required.

Yes! We offer extensive customization of port types, positions, and quantities. You can select from luer locks, MPC (AseptiQuik) connectors, hose barbs, tri-clamp fittings, septum ports, and vent filters. Common configurations include multiple fill/drain ports, top and bottom ports for complete drainage, and sampling ports at specific heights. Custom tubing lengths and materials (silicone, C-Flex, TPE) are also available. Contact us with your requirements for a quote.

Our manufacturing facility is ISO 13485:2016 certified for medical device manufacturing. All bags are produced under cGMP conditions in an ISO Class 7 cleanroom. Materials are USP Class VI compliant, and gamma sterilization follows ISO 11137. We provide complete documentation including Certificates of Conformance, gamma sterilization certificates, material certifications, and extractables/leachables data. Our products are suitable for use in pharmaceutical and biopharmaceutical manufacturing under FDA and EU regulations.

When stored properly in original packaging at room temperature (15-25°C) away from direct sunlight and moisture, our gamma-sterilized 2D bags have a shelf life of 5 years from the date of sterilization. The sterilization date and expiration date are clearly marked on each package. Bags should be inspected for package integrity before use. If the outer packaging is damaged, the sterility cannot be guaranteed.

Filling: Use top ports for filling. Ensure vent filter (if present) is open to allow air displacement. Fill to 50-80% of nominal volume for optimal mixing or to maximize volume for storage. Draining: Use bottom drain ports for gravity drainage. For complete drainage, lay bag flat and gently massage liquid toward drain port. Bags can achieve >99% drainage when properly positioned. For pumping, use peristaltic pumps with appropriate tubing connections.

Yes, our 2D bags are suitable for freezing at -20°C and -80°C. When freezing: (1) Fill to no more than 80% capacity to allow for expansion, (2) Lay bags flat for uniform freezing, (3) Freeze slowly to prevent stress on seams, (4) Thaw slowly at 2-8°C or room temperature. Note: Bags frozen with liquid contents will become rigid and must be handled carefully to avoid puncture. Do not use sharp objects near frozen bags.

Standard Configurations: In-stock items ship within 2-4 weeks from order confirmation. Custom Configurations: Manufacturing lead time is typically 6-10 weeks depending on complexity and order volume. Rush orders may be accommodated for additional fees. For urgent needs or large volume orders, please contact us to discuss expedited options.

Yes! We provide comprehensive validation support including: (1) Extractables & Leachables study data, (2) Biocompatibility testing results per ISO 10993, (3) Sterilization validation documentation, (4) Material certifications and supplier qualification, (5) Change control documentation, (6) Technical support for process validation. Our applications team can also assist with compatibility testing, process optimization, and troubleshooting. Contact us for validation support.