[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR640.68]

[Page 98-99]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS--Table of Contents
 
                        Subpart G--Source Plasma
 
Sec. 640.68  Processing.

    (a) Sterile system. All administration and transfer sets inserted 
into blood containers used for processing Source Plasma intended for 
manufacturing into injectable or noninjectable products and all interior 
surfaces of plasma containers used for processing Source Plasma intended 
for manufacturing into injectable products shall be sterile, pyrogen-
free, nontoxic, and compatible with the contents under normal conditions 
of use. Only Sodium Chloride Injection USP shall be used as a red blood 
cell diluent. If the method of separation of the plasma intended for 
injectable products involves a system in which an airway must be 
inserted into the plasma container, the airway shall be sterile and 
constructed so as to exclude microorganisms and maintain a sterile 
system.
    (b) Final containers. Final containers used for Source Plasma, 
whether integrally attached or separated from the original blood 
container, shall not be entered prior to issuance for any purpose except 
for filling with the plasma. Such containers shall be uncolored and 
hermetically sealed, and shall permit clear visibility of the contents. 
Final containers and their components shall not interact with the plasma 
contents under conditions of storage and use so as to alter the safety, 
quality, purity, or potency of the plasma and shall provide adequate 
protection against external factors that may cause deterioration or 
contamination. Prior to filling, the final container shall be marked or 
identified by number or other symbol which will relate it directly to 
the donor.

[[Page 99]]

    (c) Preservative. Source Plasma shall not contain a preservative.

[38 FR 32089, Nov. 20, 1973, as amended at 41 FR 10769, Mar. 12, 1976; 
50 FR 4140, Jan. 29, 1985]