[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: 21CFR211.72]

[Page 145]
 
                        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 D_Equipment
 
Sec.  211.72  Filters.

    Filters for liquid filtration used in the manufacture, processing, 
or packing of injectable drug products intended for human use shall not 
release fibers into such products. Fiber-releasing filters may not be 
used in the manufacture, processing, or packing of these injectable drug 
products unless it is not possible to manufacture such drug products 
without the use of such filters. If use of a fiber-releasing filter is 
necessary, an additional non-fiber-releasing filter of 0.22 micron 
maximum mean porosity (0.45 micron if the manufacturing conditions so 
dictate) shall subsequently be used to reduce the content of particles 
in the injectable drug product. Use of an asbestos-containing filter, 
with or without subsequent use of a specific non-fiber-releasing filter, 
is permissible only upon submission of proof to the appropriate bureau 
of the Food and Drug Administration that use of a non-fiber-releasing 
filter will, or is likely to, compromise the safety or effectiveness of 
the injectable drug product.

    Effective Date Note: At 72 FR 68068, Dec. 4, 2007, Sec.  211.72 was 
revised, effective Apr. 17, 2008. For the convenience of the user, the 
revised text is set forth as follows:




                        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 D_Equipment
 
Sec.  211.72  Filters.

    Filters for liquid filtration used in the manufacture, processing, 
or packing of injectable drug products intended for human use shall not 
release fibers into such products. Fiber-releasing filters may not be 
used in the manufacture, processing, or packing of these injectable drug 
products unless it is not possible to manufacture such drug products 
without the use of such filters. If use of a fiber-releasing filter is 
necessary, an additional nonfiber-releasing filter of 0.22 micron 
maximum mean porosity (0.45 micron if the manufacturing conditions so 
dictate) shall subsequently be used to reduce the content of particles 
in the injectable drug product.