[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271]

[Page 730-731]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1271_HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS--Table 
 
                 Subpart D_Current Good Tissue Practice
 
Sec.  1271.200  Equipment.

    (a) General. To prevent the introduction, transmission, or spread of 
communicable diseases, equipment used in the manufacture of HCT/Ps must 
be of appropriate design for its use and must be suitably located and 
installed to facilitate operations, including cleaning and maintenance. 
Any automated, mechanical, electronic, or other equipment used for 
inspection, measuring, or testing in accordance with this part must be 
capable of producing valid results. You must clean, sanitize, and 
maintain equipment according to established schedules.

[[Page 731]]

    (b) Procedures and schedules. You must establish and maintain 
procedures for cleaning, sanitizing, and maintaining equipment to 
prevent malfunctions, contamination or cross-contamination, accidental 
exposure of HCT/Ps to communicable disease agents, and other events that 
could reasonably be expected to result in the introduction, 
transmission, or spread of communicable diseases.
    (c) Calibration of equipment. Where appropriate, you must routinely 
calibrate according to established procedures and schedules all 
automated, mechanical, electronic, or other equipment used for 
inspection, measuring, and testing in accordance with this part.
    (d) Inspections. You must routinely inspect equipment for 
cleanliness, sanitation, and calibration, and to ensure adherence to 
applicable equipment maintenance schedules.
    (e) Records. You must document and maintain records of all equipment 
maintenance, cleaning, sanitizing, calibration, and other activities 
performed in accordance with this section. You must display records of 
recent maintenance, cleaning, sanitizing, calibration, and other 
activities on or near each piece of equipment, or make the records 
readily available to the individuals responsible for performing these 
activities and to the personnel using the equipment. You must maintain 
records of the use of each piece of equipment, including the 
identification of each HCT/P manufactured with that equipment.