[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: 21CFR606.60]

[Page 49-50]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 606_CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS--
 
                           Subpart D_Equipment
 
Sec. 606.60  Equipment.


    (a) Equipment used in the collection, processing, compatibility 
testing, storage and distribution of blood and blood components shall be 
maintained in a clean and orderly manner and located so as to facilitate 
cleaning and maintenance. The equipment shall be observed, standardized 
and calibrated on a regularly scheduled basis as prescribed in the 
Standard Operating Procedures Manual and shall perform in the manner for 
which it was designed so as to assure compliance with the official 
requirements prescribed in this chapter for blood and blood products.
    (b) Equipment that shall be observed, standardized and calibrated 
with at least the following frequency, include but are not limited to:

----------------------------------------------------------------------------------------------------------------
             Equipment                   Performance check            Frequency         Frequency of calibration
----------------------------------------------------------------------------------------------------------------
Temperature recorder..............  Compare against             Daily................  As necessary.
                                     thermometer.
Refrigerated centrifuge...........  Observe speed and           Each day of use......   Do.
                                     temperature.
Hematocrit centrifuge.............  ..........................  .....................  Standardize before
                                                                                        initial use, after
                                                                                        repairs or adjustments,
                                                                                        and annually. Timer
                                                                                        every 3 mo.
General lab centrifuge............  ..........................  .....................  Tachometer every 6 mo.
Automated blood-typing machine....  Observe controls for        Each day of use......
                                     correct results.
Hemoglobinometer..................  Standardize against         ......do.............
                                     cyanmethemoglobin
                                     standard.
Refractometer.....................  Standardize against         ......do.............
                                     distilled water.
Blood container scale.............  Standardize against         ......do.............  As necessary.
                                     container of known weight.
Water bath........................  Observe temperature.......  ......do.............   Do.
Rh view box.......................  ......do..................  ......do.............   Do.
Autoclave.........................  ......do..................  Each time of use.....   Do.
Serologic rotators................  Observe controls for        Each day of use......  Speed as necessary.
                                     correct results.

[[Page 50]]


Laboratory thermometers...........  ..........................  .....................  Before initial use.
Electronic thermometers...........  ..........................  .....................  Monthly.
Vacuum blood agitator.............  Observe weight of the       Each day of use......  Standardize with
                                     first container of blood                           container of known mass
                                     filled for correct                                 or volume before initial
                                     results.                                           use, and after repairs
                                                                                        or adjustments.
----------------------------------------------------------------------------------------------------------------

    (c) Equipment employed in the sterilization of materials used in 
blood collection or for disposition of contaminated products shall be 
designed, maintained and utilized to ensure the destruction of 
contaminating microorganisms. The effectiveness of the sterilization 
procedure shall be no less than that achieved by an attained temperature 
of 121.5 [deg]C (251 [deg]F) maintained for 20 minutes by saturated 
steam or by an attained temperature of 170 [deg]C (338 [deg]F) 
maintained for 2 hours with dry heat.

[40 FR 53532, Nov. 18, 1975; 40 FR 55849, Dec. 2, 1975, as amended at 45 
FR 9261, Feb. 12, 1980; 57 FR 11263, Apr. 2, 1992; 57 FR 12862, Apr. 13, 
1992]