21 CFR § 640.16 - Processing.

---
identifier: "/us/cfr/t21/s640.16"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 640.16 - Processing."
title_number: 21
title_name: "Food and Drugs"
section_number: "640.16"
section_name: "Processing."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "F"
subchapter_name: "BIOLOGICS"
part_number: "640"
part_name: "ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264."
regulatory_source: "38 FR 32089, Nov. 20, 1973, unless otherwise noted."
cfr_part: "640"
---


# 640.16 Processing.

(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.

(b) *Sterile system.* All surfaces that come in contact with the red cells shall be sterile and pyrogen-free.

(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.

[38 FR 32089, Nov. 20, 1973, as amended at 43 FR 34460, Aug. 4, 1978; 50 FR 4139, Jan. 29, 1985; 64 FR 45372, Aug. 19, 1999; 66 FR 1836, Jan. 10, 2001; 66 FR 40890, Aug. 6, 2001]