ValSource Chief Operating Officer Hal Baseman, along with ValSource Consultants David Hussong, Mike Long and James Vesper, are contributors to the book, Aseptic and Sterile Processing: Control, Compliance and Future Trends. Through practical, sound science, the book reassesses current risks and technologies and considers new developments in the field.
“We’ve seen a rise in regulatory concerns about adequately determining the risk factors that challenge aseptic and sterile products processing,” Hal Baseman commented. “This book calls for a paradigm shift to the industry’s understanding of sterility. Renewed emphasis is placed upon assurance and controls, including leveraging the best available technologies and conducting thorough, science-based risk assessments of processes.”
Aseptic and Sterile Processing: Control, Compliance and Future Trends, edited by Tim Sandle and Edward C. Tidswell, is available here from the PDA Bookstore. 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.