Initial validation and quality control of platelet concentrates prepared by apheresis.

Platelet concentrate (PC) prepared by apheresis is a widely used product in the practice of transfusion medicine. New machines, new protocols and/or disposables for existing machines, as well as new storage containers for the PC are being introduced with great frequency. Furthermore, additional steps such as filtration are being introduced between preparation and storage. The goal of this paper is to discuss the wide range of laboratory measurements which might be used by manufacturers of apheresis centers to validate a new procedure prior to its introduction into clinical practice. In addition, the discussion should shed light on what procedures might be used as quality control assessments by an apheresis center during the ongoing utilization of a procedure which has previously been validated. Once a PC has been prepared, it must be stored for finite period of time. A new procedure may provide a PC with a large number of platelets and few contaminating leukocytes but poor potential for storage. Therefore, any new preparative procedure must specify how long the PC may be stored and what the conditions of storage are to be. The laboratory assays to be described should be applied at the end of that storage interval.

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