Int J Pharm Compd
February 2016
Sterilization kills microorganisms in compounded preparations, on the implements used to prepare them, and on the vessels that contain them, but depyrogenation incinerates the remaining debris and renders the treated tool, container, or meditation pyrogen free. Depyrogenation is thus an essential step in the preparation of sterile compounds, and the pharmacist who dispenses those formulations is directly responsible for ensuring their safety, potency, and purity. Dry heat provided by a depyrogenation oven or tunnel is the pharmaceutical gold standard for ensuring the elimination of pyrogens.
View Article and Find Full Text PDFCompounding pharmacies, especially those awarded 503B status under the U.S. Federal Food, Drug, and Cosmetic Act that resulted from the Drug Quality and Security Act, must meet increasingly strict standards for the preparation of sterile formulations.
View Article and Find Full Text PDF