Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms to Bring Innovative Healthcare Products to Patients
Editat de Byron J. Lambert, Stan Lam, Joyce M. Hansen, Trabue D. Bryansen Limba Engleză Hardback – 29 noi 2019
This book is unique in taking a holistic, end-to-end approach to sterilization, with a particular focus on materials selection and product design.
- Introduces sterilization principles at the material selection and design stages
- Addresses the industry need for new sterilization processes for new medical devices and biomaterials
- Provides guidance to select the appropriate sterilization technique for newly developed sensitive combination products
- Examines forward thinking tactics for matching new developments in material compatibility with possible regulatory and QSR strategies
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Specificații
ISBN-13: 9780128050828
ISBN-10: 0128050829
Pagini: 266
Dimensiuni: 152 x 229 x 23 mm
Greutate: 0.53 kg
Editura: ELSEVIER SCIENCE
ISBN-10: 0128050829
Pagini: 266
Dimensiuni: 152 x 229 x 23 mm
Greutate: 0.53 kg
Editura: ELSEVIER SCIENCE
Public țintă
medical device manufacturers and consultants; contract sterilizers; microbiology test houses; regulators; Biomaterials professionals (scientists and engineers); Biomedical engineers; Academics, biomaterials and biomedical researchersCuprins
1. Introduction: Sterilization or aseptic processing of single use combination products
Joyce M. Hansen, and Trabue D. Bryans2. Sensitive combination products: Devices, pharmaceuticals, and biologics
Andrew L. Lewis3. Terminal sterilization
Vu H. Le, Scott Weiss, Brad Lundahl, and Stan Lam4. Aseptic processing
Hal Baseman5. Package/container closures
Thierry Wagner, Jennifer Van Mullekom, Jane Severin, and Michael H. Scholla6. Review of current practice in preventing health care associated infections
Donna Swenson7. Risk to the patient—Quantifying assurance of sterility
Marc L. Speck, Harry Frederick Bushar, James Niederecker, and Byron J. Lambert8. Developing new products
Stan Lam9. Regulatory pathway for labeling combination products as sterile
Trabue D. Bryans, Eamonn Victor Hoxey, and Steven Turtil10. Path forward
Byron J. Lambert, and Joyce M. Hansen