NAC585.360. Filters.

     1. Filters used in manufacturing, processing or packaging the components of any drug for parenteral injection in humans must not release fibers into the drug. No filter containing asbestos or releasing any other fiber may be used in manufacturing, processing or packaging such a drug unless the drug or its component cannot be manufactured without the use of such a filter.

     2. Filtration must be accomplished by a filter which does not release fiber, except as provided in subsections 3 and 4.

     3. If use of a filter which releases fiber is required, an additional filter which does not release fiber and has a maximum pore size of 0.22 microns (0.45 microns if the manufacturing conditions so dictate) must subsequently be used to reduce the content of any asbestos-form particles in the drug or component.

     4. Use of a filter containing asbestos followed by use of a filter which does not release fiber is permissible only if the licensee submits proof to the Commissioner that use of only the latter filter will or is likely to compromise the safety or effectiveness of the drug.

     5. For the purposes of this section:

     (a) A “filter which does not release fiber” is a filter, other than an asbestos filter, which, after any appropriate pretreatment, such as washing or flushing, will not continue to release fibers into the drug or component being filtered.

     (b) A “fiber” is any particle whose length is at least three times greater than its width.

     [Comm’r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.1.10-4.1.13.1, eff. 5-15-78]