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 patients
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