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| Product Name | Cryogenic Storage Vials, 2 mL, External Thread, Sterile |
| Catalog No. | IGM-HMM-0059 |
| Description | Sterile 2.0 mL cryogenic storage vials with external thread design and silicone O-ring seal for secure liquid and vapor phase nitrogen storage. Self-standing round bottom with white marking area and printed graduations. Gamma sterilized. |
| Intended Use | Long-term cryopreservation of cell suspensions, biological fluids, tissue samples, purified biomolecules, and clinical specimens at ultra-low temperatures in liquid nitrogen vapor phase (-135 C to -196 C) or mechanical freezers (-80 C). |
| Principle / Technology | External thread design prevents sample contact with cap threads, eliminating wicking contamination risk. Silicone O-ring compressed between cap and vial rim provides leak-proof seal at cryogenic temperatures. Virgin polypropylene maintains impact resistance at ultra-low temperatures. |
| Detection Method | Cryogenic leak test at -196 C liquid nitrogen immersion; sterility per ISO 11137; cap seal integrity by dye penetration at -80 C and LN2 temperatures; centrifugation to 17,000 x g |
| Sample Type | Mammalian cell suspensions in cryopreservation medium, bacterial glycerol stocks, tissue biopsy samples, purified proteins, nucleic acid preparations, clinical blood fractions |
| Performance Range / Specifications | Working volume 1.8 mL maximum; graduation marks at 0.5, 1.0, 1.5, 1.8 mL; temperature range -196 C to 121 C; max RCF 17,000 x g; cap assured seal >50 open-close cycles |
| Sensitivity / LOD | Endotoxin <0.1 EU/vial; cytotoxicity negative (USP <87>); nuclease non-detectable; extractable DNA <0.1 ng/vial |
| Specificity | No leachable compounds detectable after 24h water extraction at 121 C by LC-MS; silicone seal validated for non-interference with cell viability post-thaw |
| Reaction Conditions / Protocol | Fill vial to no more than 1.8 mL; tighten cap until resistance is felt; label on side marking area or cap; place in controlled-rate freezer or Mr. Frosty container; transfer to liquid nitrogen storage location. |
| Components / Formulation | Virgin polypropylene (USP Class VI) vial body, polypropylene cap, medical-grade silicone O-ring, gamma sterilized in resealable bags |
| Storage Conditions | 15-30 C prior to use; after filling, store at -80 C or in liquid nitrogen vapor phase as appropriate |
| Shelf Life | 60 months from sterilization date (unfilled); indefinite cryogenic storage when properly sealed and maintained |
| Package Specifications | 100 vials per resealable sterile bag; 500 vials per case; 50 vials per tube rack box |
| Product Form | 2.0 mL self-standing cryogenic vial, external thread, round bottom, sterile, with white marking area |
| Quality Control | Sterility to ISO 11137; cryogenic leak tested at -196 C on statistical sample; cap seal torque test; endotoxin and nuclease batch release; centrifugation integrity |
| Key Features | External thread prevents sample contamination; silicone O-ring for cryogenic seal integrity; self-standing design; large white marking patch; sterilization certified; graduated; RNase/DNase-free |
| Purity | Sterile (SAL 10^-6); DNase/RNase-free certified; endotoxin tested; non-pyrogenic; human DNA-free; non-cytotoxic |
| Concentration | N/A |
| Activity / Unit Definition | N/A |
| Molecular Weight | N/A |
| Source / Origin | USP Class VI polypropylene and medical-grade silicone; manufactured under ISO 13485 in cleanroom environment; gamma sterilized |
| pH Range / Optimal pH | Polypropylene chemically resistant pH 1-14; silicone O-ring stable across full cryogenic temperature range; compatible with cryopreservation media containing DMSO up to 10% |
| Shipping Conditions | Ambient temperature; sterile bags packed in protective cartons; vial orientation secure to prevent cap loosening |
| Expiration Date / Stability | 5 years from sterilization date for unfilled vials; indefinite cryogenic storage for filled vials with intact seal |
| Regulatory / Compliance | ISO 13485:2016; CE IVD marked; ISO 11137 sterilization; USP <661> and <87>; FDA 21 CFR 820 registered; compliant with IATA Dangerous Goods Regulations for diagnostic specimen transport |
| Compatibility | Compatible with -80 C mechanical freezers and liquid nitrogen vapor/liquid phase storage systems; fits standard cryobox storage systems (81-place and 100-place formats); compatible with color-coded cap inserts and vial identification systems |
| Recommended Buffer System | Compatible with standard cryopreservation media (DMSO-based, glycerol-based); compatible with FBS, culture medium, and commercial freezing media; silicone O-ring compatible with ethanol disinfection of vial exterior |
| Application Notes / Precautions | Do not overfill beyond 1.8 mL to allow for volume expansion during freezing; tighten cap firmly but do not overtighten; for liquid phase LN2 storage, verify cap seal integrity to prevent nitrogen ingress and potential vial explosion during thawing; warm vials in 37 C water bath with cap slightly loosened |
| Batch-to-Batch Consistency | Cap seal torque specification verified per cavity mold; silicone O-ring dimensions controlled to +/- 0.1 mm; cryogenic leak test pass rate 100% on batch release samples; sterility batch release documentation included |
For research use only, not for clinical use.
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