21 CFR § 640.102 - Manufacture of Immune Globulin (Human).

---
identifier: "/us/cfr/t21/s640.102"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 640.102 - Manufacture of Immune Globulin (Human)."
title_number: 21
title_name: "Food and Drugs"
section_number: "640.102"
section_name: "Manufacture of Immune Globulin (Human)."
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"
---


# 640.102 Manufacture of Immune Globulin (Human).

(a) *Processing method.* The processing method shall be one that has been shown: (1) To be capable of concentrating tenfold from source material at least two different antibodies; (2) not to affect the integrity of the globulins; (3) to consistently yield a product which is safe for subcutaneous and intramuscular injection and (4) not to transmit viral hepatitis.

(b) *Microbial contamination.* Low temperatures or aseptic techniques shall be used to minimize contamination by microorganisms. Preservatives to inhibit growth of microorganisms shall not be used during processing.

(c) *Bulk storage.* The globulin fraction may be stored in bulk prior to further processing provided it is stored in clearly identified hermetically closed vessels. Globulin as either a liquid concentrate or a solid and containing alcohol or more than 5 percent moisture shall be stored at a temperature of −10 °C or lower. Globulin as a solid free from alcohol and containing less than 5 percent moisture, shall be stored at a temperature of 0 °C or lower.

(d) *Determination of the lot.* Each lot of Immune Globulin (Human) shall represent a pooling of approximately equal amounts of material from not less than 1,000 donors.

(e) *Sterilization and heating.* The final product shall be sterilized promptly after solution. At no time during processing shall the product be exposed to temperatures above 45 °C, and after sterilization the product shall not be exposed to temperatures above 32 °C for more than 72 hours.

[38 FR 32089, Nov. 20, 1973, as amended at 50 FR 4140, Jan. 29, 1985; 63 FR 16685, Apr. 6, 1998; 64 FR 26287, May 14, 1999; 65 FR 13679, Mar. 14, 2000; 65 FR 52018, Aug. 28, 2000]