{"data":{"id":"us/21-cfr-640.16","jurisdiction":"us","citation":"21 CFR 640.16","heading":"Processing.","body":"(a) Separation. Within the timeframe specified in the directions for use for the blood collecting, processing, and storage system used, Red Blood Cells may be prepared either by centrifugation, done in a manner that will not tend to increase the temperature of the blood, or by normal undisturbed sedimentation. A portion of the plasma sufficient to insure optimal cell preservation shall be left with the red cells except when a cryoprotective substance or additive solution is added for prolonged storage.\n(b) Sterile system. All surfaces that come in contact with the red cells shall be sterile and pyrogen-free.\n(c) Final containers. Final containers used for Red Blood Cells shall be the original blood containers unless the method of processing requires a different container. The final container shall meet the requirements for blood containers prescribed in § 640.2(c). At the time of filing, if a different container is used, it shall be marked or identified by number or other symbol so as to relate it to the donor of that unit of red cells.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER F—BIOLOGICS","PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS","Subpart B—Red Blood Cells"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"4ed2d013e6777a9790e96d2e6fbbea8c1f61afb70864b6804403183b8e251c18","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-640.15","next":"us/21-cfr-640.17"},"notice":"GroundRules: Original legal text. Not legal advice."}