1.Details

In order to ensure the stability and safety of the bulk solution during freezing, re-thawing and transferring, Duoning developed a new frozen-transportation solution for biopharmaceutical users, which is convenient to operate and ensures consistency and reproducibility of the freeze-thaw process.

GlacierStore™ single-use freeze-thaw bag is independently developed and manufactured by Duoning. The bag body uses DuoFilm®-002 7-layer co-extruded film with thickness of 0.325 mm, and material of the liquid contact layer is ULDPE. These bags feature high strength, high flexibility, and resistant to low temperature and aging, and can be frozen in environment with temperature low to -80°C.

 

Duofilm®-002 Structure Diagram

Applications

• Cell and gene therapy

• Vaccine

• Monoclonal antibody

• Fraction collection, storage and transfer of intermediate and bulk

2.Features

Relevant tests

*Contact sales representatives or technician for detailed chemical compatibility information

Maximum Filling Volume

The low-temperature resistance and freeze–thaw protection performance of Duoning’s GlacierStore™ single-use freeze–thaw bags have been rigorously validated. When used with the protective shell, the bag design supports the maximum possible filling volume to meet user needs. The corresponding relationship between bag capacity and filling volume is as follows:

3.Advantages

These products are manufactured and packaged in ISO 14644-1:2015 Class 7 cleanroom, in compliance with relevant standards including requirements of USP, FDA, ISO and European Pharmacopoeia, and are tested for extractables by internationally renowned third-party testing laboratories in accordance with BPOG standards. The freezing test shows that after irradiation, frozen at -80°C and rethawed at room temperature, all properties were not affected and meet relevant standards.

• Bag + shell pre-assembled structure, with 3 volume specifications: 2 L, 6 L and 12 L

• Self-developed DuoFilm-002 7-layer co-extrusion film with excellent performance and can be stored in ultra-low temperature environment of -80°C for long-term use

• Advanced welding technology, heat sealing strength of welding point >30 N/15 mm

• Pass integrity test and connection firmness test after freezing, no risk of leakage

• Provide gamma irradiated product with dose of 25 kGy – 45 kGy, the SAL can reach 10^-6 according to ISO 11137 VD_MAX²⁵ method

• Single-use design, reduce the risk of contamination

• Non-cytotoxic, non-hemolytic

• Liquid contact materials comply with USP<88> CLASS VI requirement

• Animal derived component free (ADCF)

• TSE/BSE free

• Bacterial endotoxin <0.25 EU/mL

• Single-use freeze-thaw bags comply with RoHS, REACH, SDS and other relevant regulations

• Provide extractable research and validation documents on demand

• Shelf life: 2 years after irradiation

4.Specification

*The length of the main tube for 2 L bags is 66 cm/74 cm, the length of main tube for 6 L bags is 89 cm/93 cm, and the length of main tube for 12 L bags is 108 cm/112 cm.

*The product is double-layer packaged, with product label on the package, and can be traced and recorded.

*HDPE shell and bag body are pre-assembled, if disassembled without authorization which cause leakage, Duoning does not assume any responsibility.

*The above product numbers are standard configurations, Duoning can also provide shell-free freeze–thaw bags in 10 mL, 50 mL, or 150 mL sizes for process validation and development use. For these smaller bag volumes or assembly services, please contact your local sales or technical team for customized solutions

Duoning Biotech is a leading one-stop bioprocess solutions provider from China, committed to offering products and services required for the discovery, development and commercialization production of biologics, including reagents, consumables, instruments, equipment, and services. Leveraging our integrated bioprocess system, we empower our customers to achieve effective, reliable, lower-cost and higher-quality biologics manufacturing processes.