[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: 21CFR606.65]

[Page 45]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS--Table of Contents
 
                          Subpart D--Equipment
 
Sec. 606.65  Supplies and reagents.

    All supplies and reagents used in the collection, processing, 
compatibility testing, storage and distribution of blood and blood 
components shall be stored in a safe, sanitary and orderly manner.
    (a) All surfaces coming in contact with blood and blood components 
intended for transfusion shall be sterile, pyrogen-free, and shall not 
interact with the product in such a manner as to have an adverse effect 
upon the safety, purity, potency or effectiveness of the product. All 
final containers and closures for blood and blood components not 
intended for transfusion shall be clean and free of surface solids and 
other contaminants.
    (b) Each blood collecting container and its satellite container(s), 
if any, shall be examined visually for damage or evidence of 
contamination prior to its use and immediately after filling. Such 
examination shall include inspection for breakage of seals, when 
indicated, and abnormal discoloration. Where any defect is observed, the 
container shall not be used, or, if detected after filling, shall be 
properly discarded.
    (c) Representative samples of each lot of the following reagents or 
solutions shall be tested on a regularly scheduled basis by methods 
described in the Standard Operating Procedures Manual to determine their 
capacity to perform as required:

------------------------------------------------------------------------
           Reagent or solution                  Frequency of testing
------------------------------------------------------------------------
Anti-human globulin......................  Each day of use.
Blood grouping reagents..................      Do.
Lectins..................................      Do.
Antibody screening and reverse grouping        Do.
 cells.
Hepatitis test reagents..................  Each run.
Syphilis serology reagents...............      Do.
Enzymes..................................  Each day of use.
------------------------------------------------------------------------

    (d) Supplies and reagents that do not bear an expiration date shall 
be stored in such a manner that the oldest is used first.
    (e) Supplies and reagents shall be used in a manner consistent with 
instructions provided by the manufacturer.
    (f) Items that are required to be sterile and come into contact with 
blood should be disposable whenever possible.

[40 FR 53532, Nov. 18, 1975, as amended at 59 FR 23636, May 6, 1994]

Subpart E  [Reserved]

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