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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2018]
[CITE: 21CFR606.60]



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

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 recorderCompare against thermometerDailyAs necessary.
Refrigerated centrifugeObserve speed and temperatureEach day of use Do.
Hematocrit centrifugeStandardize before initial use, after repairs or adjustments, and annually. Timer every 3 mo.
General lab centrifugeTachometer every 6 mo.
Automated blood-typing machineObserve controls for correct resultsEach day of use
HemoglobinometerStandardize against cyanmethemoglobin standard......do
RefractometerStandardize against distilled water......do
Blood container scaleStandardize against container of known weight......doAs necessary.
Water bathObserve temperature......do Do.
Rh view box......do......do Do.
Autoclave......doEach time of use Do.
Serologic rotatorsObserve controls for correct resultsEach day of useSpeed as necessary.
Laboratory thermometersBefore initial use.
Electronic thermometersMonthly.
Vacuum blood agitatorObserve weight of the first container of blood filled for correct resultsEach day of useStandardize 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 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]

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