[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]
 
                        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.  1271.195  Environmental control and monitoring.

    (a) Environmental control. Where environmental conditions could 
reasonably be expected to cause contamination or cross-contamination of 
HCT/Ps or equipment, or accidental exposure of HCT/Ps to communicable 
disease agents, you must adequately control environmental conditions and 
provide proper conditions for operations. Where appropriate, you must 
provide for the following control activities or systems:
    (1) Temperature and humidity controls;
    (2) Ventilation and air filtration;
    (3) Cleaning and disinfecting of rooms and equipment to ensure 
aseptic processing operations; and
    (4) Maintenance of equipment used to control conditions necessary 
for aseptic processing operations.
    (b) Inspections. You must inspect each environmental control system 
periodically to verify that the system, including necessary equipment, 
is adequate and functioning properly. You must take appropriate 
corrective action as necessary.
    (c) Environmental monitoring. You must monitor environmental 
conditions where environmental conditions could reasonably be expected 
to cause contamination or cross-contamination of HCT/Ps or equipment, or 
accidental exposure of HCT/Ps to communicable disease agents. Where 
appropriate, you must provide environmental monitoring for 
microorganisms.
    (d) Records. You must document, and maintain records of, 
environmental control and monitoring activities.