Source: https://www.ecfr.gov/cgi-bin/text-idx?mc=true&node=sp21.7.640.f&rgn=div6
Timestamp: 2020-08-11 01:24:03
Document Index: 354745796

Matched Legal Cases: ['art 640', '§640', '§640', '§640', '§640', '§640', '§630', '§630', '§640', '§640', '§640', '§600']

Title 21 → Chapter I → Subchapter F → Part 640 → Subpart F
§640.50 Cryoprecipitated AHF.
§640.51 Eligibility of donors.
§640.52 Collection of source material.
§640.54 Processing.
§640.55 U.S. Standard preparation.
(a) Whole blood donors must meet the criteria for eligibility prescribed in §§630.10 and 630.15 of this chapter.
(b) Collection establishments must determine the eligibility of plasmapheresis donors in accordance with §§630.10 and 630.15 of this chapter.
(a) Whole blood used as a source of Cryoprecipitated AHF shall be collected as prescribed in §640.4. Whole blood from which both Platelets and Cryoprecipitated AHF is derived shall be maintained as required under §640.24 until the platelets are removed.
(b) If plasmapheresis is used, the procedure for collection shall be as prescribed in §640.64 (except that paragraph (c)(3) of that section shall not apply), and 640.65.
(3) Immediately after separation and freezing of the plasma, the plasma shall be stored and maintained at −18 °C or colder until thawing of the plasma for further processing to remove the Cryoprecipitated AHF.
A U.S. Standard Antihemophilic Factor (Factor VIII) preparation may be obtained from the Center for Biologics Evaluation and Research, (HFM-407) (see mailing addresses in §600.2 of this chapter) for use in the preparation of a working reference to be employed in a quality control potency test of Cryoprecipitated AHF.