Clean vs Sterile
Kristen D. Wiley
Materials Today - June 8, 2013
Parenteral pharmaceuticals administered subcutaneously via injection or implantation require a greater amount of quality control throughout the entire product lifecycle to ensure the health and safety of the patient. Parenterals must meet the requirements set forth by the United States Pharmacopeia (USP), whose requirements apply not only to the product, but to the primary container in which the finished product resides. In order to comply with these requirements and others in the USP, it is necessary to properly understand the differences in meaning between the terms clean and sterile.
When evaluating a product against the standards outlined in USP Methods for the Determination of Particulate Matter in Injections and Ophthalmic Solutions, the state of being ‘clean’ or ‘essentially free’ of particulate matter is often difficult to define due to the large number of variables involved in detecting the particulate. Particulate matter includes, but is not limited to, extraneous undissolved particles, fibers, glass shards, metals, polymer fragments, and skin. Particulate matter contamination can originate from undissolved drug product, processing equipment, containers and their closures, the environment, and humans. It is helpful to have a sample of the known drug product to use as a reference.