Since publication of the first edition of this book, Aseptic Processing and Packaging of Food, significant changes have taken place in several aseptic processing and packaging areas. These include changes in aseptic filling of nutritional beverages in plastic bottles; the popularity of value-added commodity products such as juice, concentrate, and
The last two decades have seen a phenomenal growth of the field of genetic or biochemical engineering and have witnessed the development and ultimately marketing of a variety of products-typically through the manipulation and growth of different types of microorganisms, followed by the recovery and purification of the associated products. The engineers and biotechnologists who are involved in the full-scale process design of such facilities must be familiar with the variety of unit operations and equipment and the applicable regulatory requirements. This book describes current commercial practice and will be useful to those engineers working in this field in the design, construction and operation of pharmaceutical and biotechnology plants. It will be of help to the chemical or pharmaceutical engineer who is developing a plant design and who faces issues such as: Should the process be batch or continuous or a combination of batch and continuous? How should the optimum process design be developed? Should one employ a new revolutionary separation which could be potentially difficult to validate or use accepted technology which involves less risk? Should the process be run with ingredients formulated from water for injection, deionized water, or even filtered tap water? Should any of the separations be run in cold rooms or in glycol jacketed lines to minimize microbial growth where sterilization is not possible? Should the process equipment and lines be designed to be sterilized in-place, cleaned-in-place, or should every piece be broken down, cleaned and autoclaved after every turn?
In aseptic processing, food is stored at ambient temperatures in sterilized containers free of spoilage organisms and pathogens. The results of this food technology come in all shapes and sizes, from the consumer packages of milk on the shelves of the supermarket to the huge containers full of orange juice transported around the world by cargo ships. Over the last couple of decades, aseptic bulk storage and distribution has revolutionized the global food trade. For example, more than 90 percent of the approximately 24 million tons of fresh tomatoes harvested globally each year are aseptically processed and packaged for year-round remanufacture into various food products. The technology has also been applied to bring potable water and emergency food aid to survivors of the 2004 tsunami in Southeast Asia and the victims of Hurricane Katrina in 2005, as well as to other crisis situations worldwide. The construction of new aseptic facilities continues around the world, and an up-to-date understanding of the technology is essential for a new generation of food scientists and engineers alike. The contributors to this important textbook discuss all aspects of aseptic processing and packaging, focusing on the areas that most influence the success or failure of the process. Fully updated, this new edition covers all areas of chemistry, microbiology, engineering, packaging, and regulations as they relate to aseptic processing.
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.
Aseptic Processing and Packaging of Food explains how aseptic processing and packaging first began and traces its fascinating progression over the last fifty years. It explores current technologies, discusses why they are used today, and explains why certain basic approaches to critical operations, such as pumping, heat exchange, fluid flow, and controls, must be applied. Commercially used heating and holding concepts are also explained, with emphasis on avoiding problems. This unique book states the technique and method of choice for accurate flow control (timing). It includes an explanation of secondary flow and describes its use to solve many of the heat exchange and fluid flow problems associated with particle-containing products. It also discusses the manufacturers of aseptic packaging equipment, exploring the types of products they produce and the advantages and disadvantages of their product design. Aseptic Processing and Packaging of Food fills in many of the information gaps left by other sources - a must-have reference for anyone working in this area.
Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book: Updates real-world CMC deficiency examples with current examples; Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance; Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.
Packaging is a complex and wide-ranging subject. Comprehensive in scope and authoritative in its coverage, Packaging technology provides the ideal introduction and reference for both students and experienced packaging professionals.Part one provides a context for the book, discussing fundamental issues relating to packaging such as its role in society and its diverse functions, the packaging supply chain and legislative, environmental and marketing issues. Part two reviews the principal packaging materials such as glass, metal, plastics, paper and paper board. It also discusses closures, adhesives and labels. The final part of the book discusses packaging processes, from design and printing to packaging machinery and line operations, as well as hazard and risk management in packaging.With its distinguished editors and expert contributors, Packaging technology is a standard text for the packaging industry. The book is designed both to meet the needs of those studying for the Diploma in Packaging Technology and to act as a comprehensive reference for packaging professionals. - Provides the ideal introduction and reference for both students and experienced packaging professionals - Examines fundamental issues relating to packaging, such as its role in society, its diverse functions, the packaging supply chain and legislative, environmental and marketing issues - Reviews the principal packaging materials such as glass, metal, plastics, paper and paper board
Engineering Principles of Unit Operations in Food Processing, volume 1 in the Woodhead Publishing Series, In Unit Operations and Processing Equipment in the Food Industry series, presents basic principles of food engineering with an emphasis on unit operations, such as heat transfer, mass transfer and fluid mechanics. - Brings new opportunities in the optimization of food processing operations - Thoroughly explores applications of food engineering to food processes - Focuses on unit operations from an engineering viewpoint
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.
Pharmaceutical packaging requires a greater knowledge of materials and a greater intensity of testing than most other packed products, not to mention a sound knowledge of pharmaceutical products and an understanding of regulatory requirements. Structured to meet the needs of the global market, this volume provides an assessment of a wide range of issues. It covers the entire supply chain from conversion of raw materials into packaging materials and then assembled into product packs. Integrating information from many drug delivery systems, the author discusses testing and evaluation and emphasizes traceability and the need to for additional safeguards.