SOLE_SOURCE_JUSTIFICATION_AND_TITLE_21.pdf

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SEE ATTACHED TITLE 21 CFR 606.60

7/14/17

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ELECTRONIC CODE OF FEDERAL REGULATIONS

e-CFR data is current as of July 12, 2017

Title 21 → Chapter I → Subchapter F → Part 606 → Subpart D → §606.60

Title 21: Food and Drugs

PART 606—CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS

Subpart D—Equipment

§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 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]

Page 1 of 1eCFR — Code of Federal Regulations

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