MiraCell is registered with the Food and Drug Administration (FDA) and operates within the confines of a Laboratory certified by Clinical Laboratory Improvement Amendments (CLIA) and utilizes state of the art equipment for processing and storing umbilical cord blood (UCB) stem cells. MiraCell has been trained, and implements, the processing protocol from the New York Blood Center for Reduction of Red Cells and Plasma from Placenta Blood.* MiraCell is registered with the American Association of Blood Banks (AABB) as an institutional member and will commence with the AABB laboratory accreditation process later in 2004. Although AABB accreditation is strictly voluntary, MiraCell acknowledges the important role the AABB fulfills by setting standards for the blood banking industry.
* Clinical training provided by ThermoGenesis Corp.
The BioArchiveĀ® System
Greater Safety and Security:
- 24-Hour Surveillance and Controlled Access.
- Uninterruptible Power Source (UPS) in the event of power failure.
- Password and Operator ID Documented Database.
- Supports Good Manufacturing Processes (GMP).
Integrated Freezing System:
- Permits robotic insertion and retrieval.
- Reduces Opportunity for Human Error.
- Controlled Freezer System and Storage Freezer all in one unit.
- Minimizes Transient Warming Events (TWE).
- Electronically records all freeze and storage characteristics for each UCB stem cell unit.
Inventory Management System:
- Utilizes ISBT 128 bar codes to eliminate potential transposition errors and enhance traceability.
- Electronically documents each UCB stem cell unit storage history.
- Automated handling precludes misplacement of UCB stem cell unit.
Our Stem Cell Storage Container
Custom, FDA approved, two compartment stem cell freezing bag.
- Detachable aliquots for confirmatory testing.
- Supports Ex-Vivo cell expansion.
- Labeled with ISBT 128 bar codes linking the two compartments, the canister and donor of the UCB stem cells.
- Hermetically sealed in a glass-transition Teflon plastic over wrap bag providing a second barrier and serving as a "quarantine bag".
The stainless steel canister:
- The canister helps to protect the freezing bag throughout the storage process and the canister's thermal properties help to facilitate proper heat transfer during the controlled rate freezing process.