- The principle of action
- The single use disposable
- The illumination device
- Specifications of the THERAFLEX MB-Plasma pocess
- What are the characteristics of the THERAFLEX MB-Plasma process?
- Increasing safety and traceability with RFID
The THERAFLEX-MB Plasma system is a photodynamic procedure using methylene blue (MB) and visible light and applied to single donor units of plasma. It employs a 0.65 µm membrane filter (Plasmaflex PLAS4, Macopharma) which removes residual leucocytes, red cells, platelets and aggregates. The filtered plasma dissolves a dry pill of 85µg anhydrous MB chloride which is integrated in the disposable providing a final concentration of 0.8 to 1.2 µM for a volume of plasma between 235 and 330 ml. Aphaeresis plasma is often split into a volume within this range. The illumination is achieved by a microprocessor-controlled device (MacoTronic B2, Macopharma). After treatment, residual MB combined with its photo products are removed by the Blueflex filter.
The THERAFLEX MB-Plasma kit incorporates a dockable set suitable for both whole blood and aphaeresis plasma. The process requires a simple dry set consisting of :
- a Plasmaflex filter for leucodepletion, removal of residual red cells, platelets and aggregates
- a Methylene Blue pill (85µg anhydrous MB chloride)
- an illumination bag
- a Blueflex filter for MB and photoproduct retention
- and a storage bag
The initial plasma volume range o be connected to the THERAFLEX MB-Plasma system is 235ml-330ml.
The MacoTronic B2 illumination device
MacoTronic B2 uses light-emitting diodes (LED) with a wavelength of 630 nm and processes 2 units per cycle in 15 minutes. The smaller size of the MacoTronic B2 allows it to be used as a benchtop illuminator.
Features of THERAFLEX MB-Plasma
Inactivation / Reduction of Pathogens
- No risk of window period or low sensitivity of available tests.
- Protection against new agents such as West Nile Virus or unknown pathogens.
- Mutation of the virus does not effect the efficacy of the method.
Cell-and fragment-free plasma
- Reduction of adverse reactions.
No lookback on donor
- No plasma wastage in case of lookback failure.
Plasma directly available after treatment
- No need for large stock, no logistical issues.
- No risk of human/labelling error if the wrong unit is released when the donor returns.
Benefits of virus-inactivated MB plasma
Raises the safety margin by inactivating pathogens that have gone undetected during screening due to window periods or test errors. Provides a proactive approach, inactivating emerging pathogens before it enters the blood supply chain and before screening tests have been developed and implemented. Single unit treatment preventing cross-contamination. Plasma from local sources in-house and on demand.
Advantages of MB-Plasma
- Efficient virus reduction (e.g. HIV, HBV, HCV, CMV, Parvovirus B19).
- Pro-active measure against upcoming viruses.
- Treatment of single units prevents cross-contamination.
- Plasma quality is maintained.
- Clinical efficacy is not affected.
- Removal of cells prevents certain adverse events.
- Production on demand (reduction of storage space, emergency cases).
- Suitable for both Whole Blood and Aphaeresis plasmas.
- RFID chip already integrated to Macopharma labels and dedicated to the storage plasma bag (donation data)
- RFID readers integrated into the MacoTronic B2 illumination machine (identification of the plasma bag during MB-treatment, storage of illumination data)
- RFID readers for the identification of the bag before MB-treatment and the transmission of the data directly to the MacoTrace and the Local Information System (LIS) of the blood centre
The use of RFID improves the safety of the process by avoiding possible user mistakes during labeling or proper identification of the bag.