New book: Aseptic and Sterile Processing: Control, Compliance and Future Trends

New book: Aseptic and Sterile Processing: Control, Compliance and Future Trends. Edited by Tim Sandle and Edward C. Tidswell.

Sterile medical products comprise of medical devices, drugs, and biologics. Some are completed  by a terminal sterilization step, thousands of the sterile products found in hospitals, clinics and pharmacies are manufactured by aseptic processing.  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. This places a considerable emphasis upon environmental control and sterility assurance. Despite this concerns of regulatory agencies suggest weaknesses in adequately determining the risk factors that are presented to aseptic and sterile products processing.

To help to check against this rise in regulator concerns, DHI and PDA have published the most important text discussing aseptic and sterile manufacturing to be published in the last decade. The 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.

The lessons from the leading practitioners are aimed squarely at those involved with aseptic and sterile processing. Such readers will be able take away many learning points and apply these principles to aseptic and sterile processing within the pharmaceutical and healthcare sectors. The book will also appeal to students of pharmaceutical sciences.

A central theme with the new book is that it is time for a new paradigm in relation to our understanding sterility, given that many microorganisms cannot be cultured. This places a renewed emphasis upon assurance and controls; a thorough science-based risk assessment of processes; and by taking advantage of the best available technologies.

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