Regulations last checked for updates: May 02, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025
§ 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 be used when it is not possible to manufacture such products without the use of these filters. If use of a fiber-releasing filter is necessary, an additional nonfiber-releasing filter having a maximum nominal pore size rating of 0.2 micron (0.45 micron if the manufacturing conditions so dictate) shall subsequently be used to reduce the content of particles in the injectable drug product. The use of an asbestos-containing filter is prohibited.

[73 FR 51932, Sept. 8, 2008]
source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted.
cite as: 21 CFR 211.72