[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.46]

[Page 142-143]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 211_CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--Table of Contents
 
                   Subpart C_Buildings and Facilities
 
Sec.  211.46  Ventilation, air filtration, air heating and cooling.

    (a) Adequate ventilation shall be provided.
    (b) Equipment for adequate control over air pressure, micro-
organisms, dust, humidity, and temperature shall be provided when 
appropriate for the manufacture, processing, packing, or holding of a 
drug product.
    (c) Air filtration systems, including prefilters and particulate 
matter air filters, shall be used when appropriate on air supplies to 
production areas. If air is recirculated to production areas, measures 
shall be taken to control recirculation of dust from production. In 
areas where air contamination occurs during production, there shall be 
adequate exhaust systems or other systems adequate to control 
contaminants.
    (d) Air-handling systems for the manufacture, processing, and 
packing of penicillin shall be completely separate

[[Page 143]]

from those for other drug products for human use.