§ 606.60 Equipment.
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Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER F—BIOLOGICS > PART 606—CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS > Subpart D—Equipment
Text
(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 thermometer
Daily
As necessary.
Refrigerated centrifuge
Observe speed and temperature
Each day of use
Do.
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 correct results
Each day of use
Hemoglobinometer
Standardize against cyanmethemoglobin standard
......do
Refractometer
Standardize against distilled water
......do
Blood container scale
Standardize against container of known weight
......do
As necessary.
Water bath
Observe temperature
......do
Do.
Rh view box
......do
......do
Do.
Autoclave
......do
Each time of use
Do.
Serologic rotators
Observe controls for correct results
Each day of use
Speed as necessary.
Laboratory thermometers
Before initial use.
Electronic thermometers
Monthly.
Vacuum blood agitator
Observe weight of the first container of blood filled for correct results
Each day of use
Standardize with container of known mass or volume before initial 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 °C (251 °F) maintained for 20 minutes by saturated steam or by an attained temperature of 170 °C (338 °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]
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