[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR640.68]

[Page 109-110]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 640_ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS--Table of 
 
                         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

[[Page 110]]

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.
    (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]