[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.46]

[Page 119-120]
 
                        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

[[Page 120]]

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 from those for other 
drug products for human use.