GlacierStore™ single-use freeze-thaw bag
GlacierStore™ single-use freeze-thaw bag is to ensure the stability and safety of the bulk solution during freezing, re-thawing and transferring. 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. which is convenient to operate and ensures consistency and reproducibility of the freeze-thaw process.
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.
Applications
- Cell and gene therapy
- Vaccine
- Monoclonal antibody
- Fraction collection, storage and transfer of intermediate and bulk
Product Features
- 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 VDMAX25 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
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