Ophthalmic medications must meet particulate matter test requirements. Particulate matter may come from foreign or product-related substances. Clinical exposure to unwanted particulate matter can cause a biological response in patients including blocking capillaries and arteries, introducing microorganisms and causing an infection, or causing an allergic reaction.
A cleaning validation demonstrates a pharmacy, hospital, or outsourcing facility's cleaning procedure is effective and consistent in cleaning equipment and compounding surface areas. The Food and Drug Administration (FDA) expects firms to have written procedures (SOP's) detailing the cleaning processes used for various pieces of equipment. According to the FDA, 21 CFR Part 211, "Equipment and utensils shall be cleaned, maintained, and, as appropriate for the nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements." A cleaning validation is how one proves their cleaning SOPs are sufficient.
United States Pharmacopeia published the revised <795> and <797> chapters November 1, 2022. These chapters become official November 1, 2023. Revisions to the chapters can be accessed through a subscription to the USP Compounding Compendium.