CFR section
21 CFR 640.34(c): Processing
PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS · Subpart D-Plasma
Key facts
| Citation | 21 CFR 640.34(c) |
|---|---|
| Section | Processing |
| Part | PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS |
| Subpart | Subpart D-Plasma |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics |
| Regulation text (excerpt) | (c) Liquid Plasma. Liquid Plasma shall be separated from the red blood cells and shall be stored at a temperature of 1 to 6 °C within 4 hours after filling the final container or within the timeframe specified in the directions for use for the blood collecting, processing, and storage system. |
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