CFR section
21 CFR 640.25(a): General requirements
PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS · Subpart C-Platelets
Key facts
| Citation | 21 CFR 640.25(a) |
|---|---|
| Section | General requirements |
| Part | PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS |
| Subpart | Subpart C-Platelets |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Devices, Drugs |
| Regulation text (excerpt) | (a) Storage. Immediately after resuspension, Platelets shall be placed in storage at the selected temperature range. If stored at 20 to 24 °C, a continuous gentle agitation of the platelet concentrate shall be maintained throughout the storage period. Agitation is optional if stored at a temperature between 1 and 6 °C. |
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