Sterile Basics of Compounding: Particulates in Parenteral Preparations: Sources, Minimization, and Detection

Parenteral solutions may include particulate matter that can be introduced from several different sources, including the active pharmaceutical ingredients, excipients, vehicles, cosolvents, buffers, preservatives, antioxidants, inert gases, surfactants, complexing agents, collecting agents, and others. Also, personnel involved in compounding parenteral drugs can be a source of particulates; this emphasizes the importance of adhering to proper compounding procedures in a proper environment during which compounding personnel should be properly garbed during the compounding. The container itself, whether it be plastic or glass, may also be a source of particulates. The identification of these particulates is important for the quality-control personnel to identify any issues that might be involved in adhering to required standards for sterile compounding. The United States Pharmacopeia has a number of chapters which are applicable to the compounding of sterile preparations, and the compounding personnel involved in compounding sterile preparations should be familiar with and adhere to the United States Pharmacopeia Chapter <797> standards for sterile preparations. The United States Pharmacopeia also includes inspecting injectable solutions, even though particulate matter testing presents many difficulties for the quality-control specialist. In addition to inspection and analysis of the parenteral solutions for the presence of foreign particulate matter, particulate matter testing includes procedures for removing, counting, and sizing contaminants in injections and ophthalmic solutions. There are four United States Pharmacopeia general chapters related to particulate matter in sterile products, including 1) Chapter <787> Subvisible Particulate Matter in Therapeutic Protein Injections, 2) Chapter <788> Particulate Matter in Injections, 3) Chapter <789> Particulate Matter in Ophthalmic Solutions, and 4) Chapter <790> Visible Particulates in Injection, all of which are discussed in this article.