The Sepax cell separation system is a modern cell centrifugation device for fast and automated processing of blood and its components.
- An important tool which gives the possibility to keep both technical and patient data for each procedure performed with the Sepax system. Data for all procedures can be saved in the Sepax memory card and also be printed.
- The traceability features and devices include a thermal printer, a bar code reader, managing software, cables and connector protections.
- Umbilical Cord Blood Processing
- Biosafe provides three protocols to process umbilical cord blood:
- Umbilical Cord Blood-HES (UCB-HES): It is based on the sedimentation agent Hydro-Ethyl Starch.
- Umbilical Cord Blood processing (UCB)- No Additives: This protocol does not require additives. This separation protocol is ideally suited to UCB banking where storage costs need to be minimized and the use of additives is a concern.
- Umbilical Cord Blood-Low Buffy-Coat Volume (UCB-LBC): This protocol produces very small buffy-coat volume.
- Umbilical Cord Blood Stem Cell Washing Protocol-Post Thawing (The UCB Washing Protocol):
- This protocol is designed for automated washing of thawed cord blood units in a closed system.
- The washed Cells are viable for hours which also allow further processing without time constraints. This washing protocol is recommended when a safe and automated removal of
- DMSO and hemolysed plasma from thawed UCB products is desired.
Peripheral Blood Processing:
- Biosafe provides two protocols to process PBSC products:
- PBSC Volume Reduction: This protocol is designed for reducing volume of peripheral blood stem cell (PBSC) preparations after leukapheresis. The hematopoietic stem cells can then be frozen and stored until future transplantation into a patient. This protocol is recom- mended when optimization of cell concentration and reduction of DMSO toxicity are a concern.
- Peripheral Blood Stem Cell Washing: This protocol is designed for automated and safe removal of DMSO and hemolysed plasma from thawed leucapheresis products. The washed cells are viable for hours which also enable further process without time constraints.
Bone Marrow Processing:
- Biosafe provides two protocols:
- The Generic Volume Reduction Protocol: This protocol is designed for efficient separation of stem cells in a closed system. This protocol is conceived for volume reduction of different blood products and specially adapted for bone marrow applications in transplantation and regenerative medicine applications.
- The Density Gradient based Separation Protocol: This protocol is designed for bone marrow or umbilical cord blood processing in regenerative medicine applications. This protocol is recommended when optimization of cell concentration and high depletion of RBC are a concern.
The smart max device has multiple functions:
Preparing cellular products for cryopreparation with automated mixing and cooling technology
Preparing cellular products for infusion by thawing or incubation of frozen products.
Adding reagents such as cryoprotectant or dillution media at a controlled rate into cellular products
Potential to be used in incubation, digestion and other cell therapy applications
The Smart-Max is a hands-free device designed for safe and reproducible procedures. It allows multiple units of various sizes to be connected at once. A data storage and transfer function allows the traceability of each unique unit.
- USB ports to connect printer, barcode scanner, memory sticks and other usual PC interfaces.
LAN, WLAN integration.
- User selectable multi-language support.
- Enhanced traceability features (eg collect patient file via USB)
- Pneumatic mixing technology for optimal product mixing during reagent infusion.
- Universal cooling plate for small and large volume blood bags.
- Possibility of cooling down to 1oC and heating up to 50oC.
- 2 peristaltic to inject DMSO infusion, parallel infusions possible.
- Possibility to inject DMSO in two cryobags at the same time (dual platform).
- Remote access possibility via internet.
- The mechanical platform for cooling and heating.
- The pneumatic cuff bags for mixing.
- The perialistic pumps for the injection of biological additives.
Safety and Performance
Smart-Max will comply with the directive 93/42/CEE for medical devices, including the electrical safety standard IEC 60601-1.
The Smart-Max should only be operated on a flat, horizontal and clean surface with enough surrounding space to allow proper ventillation and operation procedures. The Smart-Max must only be used / stored under the following environmental conditions
||Storage and Transport
||+7oC to 27oC
||0oC to 50oC
||30% to 75%, non-condensing
||20% to 75%, non-condensing