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Our facility is updating our floor model centrifuge which will product volume reduced platelets (Apheresis Platelet which is Plasma Reduced). I'm interested if anyone has validated this process in their facility, and if so...what product parameters did you use to ensure volume reduction yielded viable platelets? We will be performing IQ/OQ of the centrifuge but in planning for the PQ of the product, we are initially considering: - volume of product pre/post - platelet count in pre/post (or lack of platelet/reduction of platelets in the 'removed' portion...) - visual inspection of vol reduced platelet (i.e., the swirling of platelets) If you've recently done it, know of any good references or can share any good (or bad!) experiences, please do! I imagine it would be similar if you've recently validated washing platelets, too... Thanks - and happy 4th!
