Table 8.25
Update notice: text HIGHLIGHTED has changed following the issue of Change Notifications 1 and 2 - 2012
Table 8.25 Plasma components| Component name | Technical information | Storage temp. (°C) | Max. storage period (months) | Transport temp. (°C) | Volume (mL) | Platelet yield (x 109/L) | FVIIIc (IU/mL) | FVIIIc (IU/unit) | Fibrinogen (mg/unit) |
|---|
| LSL | USL | USL | LSL | LSL | LSL |
|---|
| Fresh Frozen Plasma, Leucocyte Depleted | Plasma that has been obtained from whole blood or by apheresis from a previously tested donor (as defined in Section 8.3).
The plasma has been rapidly frozen to a temperature that will maintain the activity of labile coagulation factors.
The Total Protein content should be >50g/L. | <-25 | 24
(Up to 24 hours post thaw at 4°C) | <-25 | Local | Local | 30 (Plt)
6 (Rbc) | 0.70 | | |
| Fresh Frozen Plasma, Methylene Blue Treated and Removed, Leucocyte Depleted | The components are produced from plasma that has been obtained from whole blood or by apheresis from a previously tested donor (as defined in Section 8.3) and has been treated with methylene blue and exposure to visible light to reduce pathogens.The Methylene Blue is subsequently removed using an adsorption filter.
The MB removal filter must have been shown to be capable of reducing methylene blue in the final component to ≤0.30µM (approximately 30µg per unit).The concentration pre removal is approximately 1µM (<100µg/unit).
The components need not be tested for leucocyte or platelet contamination where it is derived from frozen and thawed plasma unless the counting methodology is validated for frozen/thawed plasma or where the source plasma is monitored.
Ideally the plasma should be separated before the red cell component is cooled to its storage temperature.
The Methylene Blue treatment process reduces the FVIII:C content by approximately 30% when compared to standard FFP. | <-25 | 24
(Up to 24 hours post thaw at 4°C) | <-25 | Local | Local | 30 (Plt) | 0.50 | | |
| Cryoprecipitate, Leucocyte Depleted | The component represents a source of concentrated FVIII:C, and von Willebrand factor, fibrinogen, Factor XIII and fibronectin from a unit of Fresh Frozen Plasma, Leucocyte Depleted.The plasma from which the Cryoprecipitate, Leucocyte Depleted was derived is from a previously tested donor (as defined in Section 8.3).
Cryoprecipitate, Leucocyte Depleted is the cryoglobulin fraction of plasma obtained by thawing a single donation of fresh frozen plasma at 4°C ± 2°C. | <-25 | 24 | <-25 | Local | Local | | | 70 | 140 |
| Cryoprecipitate, Methylene Blue Treated and Removed, Leucocyte Depleted. See Table 8.28. |
| Plasma, Cyroprecipitate Depleted, Leycocyte Depleted | The supernatant plasma removed during the preparation of Cryoprecipitate, Leucocyte Depleted.The plasma from which the Plasma, Cryoprecipitate Depleted, Leucocyte Depleted was made was derived from a previously tested donor (as defined in Section 8.3). | <-25 | 24
(Up to 24 hours post thaw at 4°C) | <-25 | Local | Local | 30 (Plt)
6 (Rbc) | | | |