Advanced Aseptic Processing Technology

The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies

Sterile Pharmaceutical Products: Process Engineering Applications addresses the key concepts and applications of the sterile pharmaceutical manufacturing industry. It covers elements of the design, installation, validation, and usage of critical processes associated with sterile product manufacture. From water systems to clean-in-place systems, to sterile powder handling and robotic applications in sterile production environments, this book addresses the issues of system implementation, integration, and operations. Written by recognized experts and peer reviewed for accuracy, all chapters include references to supplemental resources and numerous illustrations.

Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers aseptic technology, developments, and applications and makes a valuable contribution to understanding the issues involved in aseptic manufacture. Topics include the processing of biopharmaceuticals, lyophilization, personnel training, radiopharmaceuticals, hydrogen peroxide vapor sterilization, regulatory requirements, validation, and quality systems.

This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.

Publications in food technology proliferate; however, noticeable by its absence of coverage is the subject of processing and packaging of particulates in foods. Recent years have seen significant advances which will almost certainly result in substitution of existing and conventional retorting. In addition, when com bined with high temperature/short time (HTST) processing, we can expect substantial further growth, reflecting quality and convenience advantages over products processed from yesterday's technologies. The anticipated growth in particulates is driven by both materials and packaging advances and only requires modest marketing of the organoleptic advantages to establish their place on menu options. The directions taken in packaging developments, especially those interfacing with the latest and established methods of processing, are increasingly influ enced by the need to design packaging on a cradle-to-grave basis. Time was when multi-laminated films on board satisfied the total needs of consumers of aseptic products. The problems of recycling combustible, i.e. energy generating mate rials laminated with aluminium foil, are becoming sensitive issues in a world preoccupied with recycling, and are creating openings for alternative and envi ronmentally friendly material combinations. This book brings together advanced technologies in the field, to provide information for professionals with interests in aseptic processing on how to go about selecting a system appropriate to their commercial needs and constraints.

This book covers all aspects of containment technology in depth and the latest developments in this exciting field are introduced. This book is a key publication to planning engineers, production managers and those interested in getting a picture of the different applications of the isolator technology. References on literature, laws, norms and guidelines will support the reader to become acquainted with the containment technology.