In order to ensure the stability and safety of the bulk solution during freezing, re-thawing and transferring, Lianghei (A Duoning Company) developed 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 Lianghei. 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.
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 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
Applications
? Cell and gene therapy
? Vaccine
? Monoclonal antibody
? Fraction collection, storage and transfer of intermediate and bulk
Relevant tests
Chemical compatibility | |
Acid solution | Acceptable |
Base solution | Acceptable |
Common organic solution | Acceptable |
*Contact sales representatives or technician for detailed chemical compatibility information
Physical performance | Biocompatibility & Particulate | |||
Irradiation tolerance test | Pass | In vitro biocompatibility | USP<87> ISO 10993-3 ISO 10993-4 ISO 10993-5 | |
Repeated freezing test after irradiation | Pass | In vivo biocompatibility | USP<88> ISO 10993-6 ISO 10993-10 ISO 10993-11 | |
Drop test after freezing | ASTM D4169 | Bacterial endotoxin | USP<85> | |
Connection firmness, heat seal and integrity test before and after freezing | Pass | Extractables | BPOG | |
Physical chemistry test | USP<661> EP<3.2.2.1> | Insoluble particles | USP<788> | |
In vitro biocompatibility | USP<87> ISO 10993-3 ISO 10993-4 ISO 10993-5 | |||
Ordering information
Product name | Part No. | Configuration | HDPE Shell Dimension (Length*Width*Height, mm) | QTY |
GlacierStore? single-use freeze-thaw bag, 2 L, with silicone tube, quick connector, HDPE shell | SUS-S-R000212G | Inlet: silicone tube + CPC female connector + plug Outlet: silicone tube + CPC male connector + plug Sampling: silicone tube 20 cm + needleless sampler | 469*370*84 | 4 pcs/box |
GlacierStore? single-use freeze-thaw bag, 6 L, with silicone tube, quick connector, HDPE shell | SUS-S-R000612G | 648*430*105 | 2 pcs/box | |
GlacierStore? single-use freeze-thaw bag, 12 L, with silicone tube, quick connector, HDPE shell | SUS-S-R001212G | 743*512*120 | 2 pcs/box | |
GlacierStore? single-use freeze-thaw bag, 2 L, with silicone tube, aseptic connector, HDPE shell | SUS-S-R000222G | Inlet: silicone tube + CPC aseptic connector Outlet: silicone tube + CPC aseptic connector Sampling: silicone tube 20 cm + needleless sampler | 469*370*84 | 4 pcs/box |
GlacierStore? single-use freeze-thaw bag, 6 L, with silicone tube, aseptic connector, HDPE shell | SUS-S-R000622G | 648*430*105 | 2 pcs/box | |
GlacierStore? single-use freeze-thaw bag, 12 L, with silicone tube, aseptic connector, HDPE shell | SUS-S-R001222G | 743*512*120 | 2 pcs/box | |
GlacierStore? single-use freeze-thaw bag, 2 L, with TPE tube, HDPE shell | SUS-S-R000232G | Inlet: TPE tube + plug Outlet: TPE tube + plug Sampling: silicone tube 20 cm + needleless sampler | 469*370*84 | 4 pcs/box |
GlacierStore? single-use freeze-thaw bag, 6 L, with TPE tube, HDPE shell | SUS-S-R000632G | 648*430*105 | 2 pcs/box | |
GlacierStore? single-use freeze-thaw bag, 12 L, with TPE tube, HDPE shell | SUS-S-R001232G | 743*512*120 | 2 pcs/box |
*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, if you need bags with other volume or assembly services, please contact local sales representative or technician.
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