CBS High Security Tubes
The unique fully secured system for storage in liquid nitrogen.
These are the optimum devices are the perfect replacement for Cryo Vials for semen and ovarian tissue freezing under liquid nitrogen. Available in a box of 20 individually wrapped, or a box of 50.
CBS High Security tubes are derived from the CBS high security concept designed for optimum sample preservation. Made of biocompatible resin, CBS tubes eliminate concerns related to cross-contamination and issues induced by storage in liquid nitrogen.
Once sealed with the SYMS III sealer, the CBS High Security tube will be placed in storage boxes and in current storage systems. The tubes can be opened with either special scissors or the SYSO automatic opening device.
The CBS High Security tube is CE marked and has Class II/a medical device certification; offering the opportunity for use in clinical phases and for therapeutic purposes.
Safety
- Full seals eliminate risks of cross-contamination of the sample and its environment.
- Validated as leak-proof and shatter-proof in all cryogenic temperatures including temperatures as low as liquid nitrogen phase.
- Indestructible under normal conditions of use.
Traceability options
- Colored inserts for simple identification in cryogenic environments
- 2D data matrix coded inserts
- Compatible with cryoresistant labels.
Compatibility
- Standard racks, boxes (9x9 or 10x10), canes
- Manual or automatic filling systems
- Programmable freezers
- Cryogenic storage conditions for use in liquid nitrogen, vapor phase, mechanical freezers
Fields of application
- Preservation of fertility (ovarian and testicular tissue, and sperm) for Assisted Reproductive Technologies
- Biological tissue banks for clinical phase or research
- Blood banks and blood transfusion centers
- Cell and genetic therapy (clinical phase and therapeutic applications)
- Packaging of vaccines and heat-sensitive drugs
Characteristics
- Usable working volume: 1.2mL
- Dimensions: 48 mm, Ø 11.8 mm
- Service temperature: from + 40°C to cryogenic temperature -196°C
- Liquid nitrogen and vapor phase validated
- 2D data matrix capacity: 10 digits
- 2D data matrix symbol size: 12 x 12 (rows x columns).
Flyer
Validation Studies
Validation Study Details
Specifications
| SKU 022252 | CBS High Security Tubes. Box of 20. Individually wrapped. |
| SKU 023722 | CBS High Security Tubes. Box of 50. |
CBS™ High Security Tubes are produced under GMP and ISO 7 conditions.
Cryo Bio System is ISO 13485 certified.
A complete testing program has been realized to validate the use of CBS™ High Security Tubes for cryopreservation of biological samples.
QUALITY ASSURANCE
Sterile CBS™ High Security tubes have been tested on:
- Endotoxin by LAL methodology (<1 EU/unit)
- One cell Mouse Embryo Assay (>80% expanded to blastocysts in 96h)
- Sterilization by irradiation to a Sterility Assurance Level (SAL) of 10(-6)
All results are reported on a lot specific ‘Certificate of analysis’, which is available upon request.
PRODUCT VALIDATION
CBS™ High Security Tubes made from virgin grade ionomeric resin have been
validated on:
Cell Toxicity: No difference in cell survival and development between CBS™ High Security Tubes and standard cryogenic vials
Protocol: Three cell lines (MRC 5, BXPC3 and CCRF-CEM) pipetted at room temperature, sealed, frozen, stored under liquid nitrogen and thawed in CBS™ High Security Tubes and in standard cryogenic vials. Laboratory: IZSLER, Italy
DNAses and RNases : Product is free of detectable DNases and RNases
Protocol: CBS™ High Security tubes are successively vortex washed with 200 µl DEPC water. RNA and DNA standards are incubated 1h at 37°C and 5 min at 65°C with extraction fluid (that has been in contact with sample Y/N) and then quantified for comparison. Laboratory: Mo Bio, USA
Pyrogenicity: Pyrogen free
Protocol: In vivo pyrogen test USP<151> and Pharm Eur 2.6.8.
Extractables:
Bisphenol A: No detectable level of Bisphenol A
Protocol: Analysis by HPLC – UV acetonitrile extract, 5h ultrasound, room temperature. Laboratory Intertek, France
Parabenes: No detectable levels of methylparaben, ethylparaben, propylparaben, butylparaben, isobutylparaben
Protocol: Analysis by HPLC-UV of (mixtures of) extraction solvents: acetonitrile, methanol, methanol-acetonitrile, THF-methanol, acetonitrile) after 5 + 5 hours ultrasound. Laboratory Intertek, France
Phtalates: No detectable levels of DMP, DIHxP, DPP, DNHP, BBP, DBEP,
DnOP, DNP, DMEP, DINP, DIDP. No quantifiable levels of DEP, DBP, DIBP,
DEHP and DCHP
Protocol: GC-MS analyses of two toluene extracts (5 hours ultrasound. Laboratory Intertek, France
No other carcinogen/mutagen/reproductive toxic components detected
Leachables: Based on the absence or very low concentrations of extractables, no leachables studies have been done
Cell Cryopreservation: No difference in cell survival and development over 6 days between CBS™ High Security Tubes and standard cryogenic vials
Protocol: Three cell lines (MRC 5, BXPC3 and CCRF-CEM) pipetted, sealed, CRF frozen (-1°C/min from +5°C till -40°C, -10°C/min from -40°C till -70°C and immersion in LN2) and 37°C water bath thawed in new CBS and in standard ST vials . Replication and development counted for 6 days. Laboratory: IZSLER, Italy
Cross contamination in the sealing process: No cross contamination was detected between highly contaminated and non-contaminated CBS™ High Security Tubes successively sealed with the same SYMS II sealer
Protocol: Two cell lines (PK15cl 28/BS, MDBK) contaminated or not with mycoplasma orale and bovine entero virus in CBS™ High Security Tubes and in standard cryogenic vials for controls . Real-time PCR for detection of mycoplasma DNA. Virus infection detection by isolation technologies
Cross contamination in liquid nitrogen storage: No cross contamination was detected between highly contaminated and non-contaminated CBS™ High Security Tubes immerged for 3 weeks in the same liquid nitrogen vessel.
Protocol: Two cell lines (PK15cl 28/BS, MDBK) contaminated or not with mycoplasma orale and bovine entero virus in CBS™ High Security Tubes and in standard cryogenic vials for controls. Real-time PCR for detection of mycoplasma DNA. Virus infection detection by isolation technologies
Resistance to immersion and storage in liquid nitrogen: No break after direct immersion in liquid nitrogen followed by storage under liquid nitrogen
Protocol: CBS™ High Security Tubes filled with 1 ml of water at room temperature are thermally sealed and immediately immerged in liquid nitrogen and stored for 48 hours.
Tubes are pressure tested for leakage after warming.
Resistance to centrifugation forces: No break or leaks at 3000 G for 10 minutes at 22°C
