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Electronic Code of Federal Regulations

e-CFR data is current as of May 28, 2020

Title 21Chapter ISubchapter FPart 606 → Subpart D


Title 21: Food and Drugs
PART 606—CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS


Subpart D—Equipment


Contents
§606.60   Equipment.
§606.65   Supplies and reagents.

§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:

EquipmentPerformance checkFrequencyFrequency 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 °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]

§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 solutionFrequency of testing
Anti-human globulinEach day of use.
Blood grouping reagents      Do.
Lectins      Do.
Antibody screening and reverse grouping cells      Do.
Hepatitis test reagentsEach run.
Syphilis serology reagents      Do.
EnzymesEach 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]

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