Sterile medical products comprise of medical devices, drugs, and biologics. These are products intended for patients who have weak or compromised immune systems. This means a contaminated product will the patient’s condition worse or result in death. A new book considers the state of sterile products manufacturing both today and tomorrow. The book is edited by two leading experts in aseptic and sterile products manufacture: Dr. Tim Sandle and Dr. Edward Tidswell.

To produce this comprehensive text the editors sought out leading industry and academic figures to help reassess current risks and technologies, and to represent new developments in the field. The aim was to produce a book that was foremost practical, but also grounded in sound science. Among the subjects covered are contamination risks, regulations, bioburden control, endotoxin control, water systems, depyrogenation, filtration, microbial contamination risks to cleanrooms, environmental monitoring, aseptic process simulations, single-use disposable technology, disinfection, sterility testing, cleanroom operator controls, risk assessment, human error and rapid methods.

Among the subject matter experts enlisted are: David Hussong, James Agalloco, James Akers, Maik W. Jornitz, Teri C. Soli, James Vesper, Hal Baseman, Anne Marie Dixon-Heathman, Michael Miller, Mark Trotter, Karen Zink McCullough, Matts Ramstorp, Crystal Booth, Mark Hunter and others highly experienced in their specialist subjects.

Aseptic and Sterile Processing: Control, Compliance and Future Trends is available from the PDA Bookstore, at: store.pda.org/ProductCatalog/Product.aspx?ID=3850