Plasma for SD Plasma Processing Sample Clauses

Plasma for SD Plasma Processing. (the "PSDP") - The fluid portion of whole blood (Human) collected in the U.S. by FDA-licensed blood centers from volunteer, non-remunerated donors and containing no additives other than FDA approved anti-coagulant. The plasma must have been drawn from adult humans who are in good physical condition to give blood, in so far as can be determined by personal history and physical examination on the date of collection. In order for plasma to be acceptable for use in the production of SD Plasma it needs to meet the requirements for Recovered Plasma (Frozen) or Source Plasma from plateletpheresis or plasmapheresis as well as the additional requirements outlined in these SPECIFICATIONS. The plasma shall be separated from red cells and frozen solid no longer than ******** after collection. (It is preferable for the plasma derived from a whole blood collection to be separated from both red cells and platelets, but this is not --- required.) The plasma shall be frozen flat and stored continuously at ************* or below. Once frozen, plasma may not be thawed.
Sample 1
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Plasma for SD Plasma Processing. (the "PSDP") - The fluid portion of whole blood (Human) collected in the U.S. by FDA-licensed blood centers from volunteer, non-remunerated donors and containing no additives other than FDA approved anti-coagulant. The plasma must have been drawn from adult humans who are in good physical condition to give blood, in so far as can be determined by personal history and physical examination on the date of collection. In order for plasma to be acceptable for use in the production of SD Plasma it needs to meet the requirements for Recovered Plasma (Frozen) or Source Plasma from plateletpheresis or plasmapheresis as well as the additional requirements outlined in these SPECIFICATIONS. The plasma shall be separated from red cells and frozen solid no longer than ******** after collection. (It is preferable for the plasma derived from a whole blood collection to be separated from both red cells and platelets, but this is not required.) The plasma shall be frozen flat and stored continuously at --- ************* or below. Once frozen, plasma may not be thawed. Plasma for SD Plasma Processing must be collected, prepared (processed), labeled and stored in accordance with these SPECIFICATIONS and in a manner fully consistent with plasma or any blood component intended for transfusion, e.g. FFP or Red Blood Cell Concentrate. PSDP needs to be labeled by ABO type. As such, PSDP must undergo a blood center's normal cGMP practices for unit release and labeling and ultimate release for distribution (i.e. release for transport by VITEX's authorized carrier to VITEX for SD Plasma Processing) as would be the case for any labeled blood component intended for transfusion. VITEX RETAINS THE RIGHT TO REJECT OR OTHERWISE NOT ACCEPT ANY UNITS OF PLASMA FOR SD PLASMA PROCESSING WHENEVER IT BELIEVES, IN ITS SOLE DISCRETION, THAT THE UNITS SUPPLIED ARE NOT IN FULL CONFORMANCE WITH THESE SPECIFICATIONS.
Sample 1

Related to Plasma for SD Plasma Processing

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