The AAMI recommended practice, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, is a breakthrough standard in terms of its scope. AAMI has updated ST79 with the release of ST79:2010/A4:2013. Of particular importance, A4:2013 provides four new figures demonstrating the wrapping of items for steam sterilization and adds an annex focused on Moisture assessment. As of Oct. 25, 2013, purchasers of ST79 will receive ANSI/AAMI ST79:2010 and A1:2010 and A2:2011 and A3:2012 and A4:2014 as a single consolidated document. Among other changes from the 2006 edition of ST79, this revised and expanded second edition of ST79 includes guidance on the use and application of Class 6 emulating indicators, a chemical monitoring device fairly new to the United States. Because ST79 essentially consolidates five AAMI steam sterilization standards (whose content was reviewed and updated to reflect current good practice prior to being incorporated into ST79), it truly is a comprehensive guideline for all steam sterilization activities in healthcare facilities, regardless of the size of the sterilizer or the size of the facility, and provides a resource for all healthcare personnel who use steam for sterilization.

A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.

Methods for processing of biological materials into useful products represent essential core manufacturing activities of the food, chemical and pharmaceutical industries. On the one hand the techniques involved include well established process engineering methodologies such as mixing, heat transfer, size modification and a variety of separatIon and fermentation procedures. In addition, new bioprocessing practices arising from the exciting recent advances in biotech nology, including innovative fermentation cell culture and enzyme based operations, are rapidly extending the frontiers of bioprocessing. These develop ments are resulting in the introduction to the market place of an awesome range of novel biological products having unique applications. Indeed, the United States Office of Technology Assessment· has concluded that 'competitive advantage in areas related to biotechnology may depend as much on developments in bioprocess engineering as on innovations in genetics, immunology and other areas of basic science'. Advances in analytical instrumentation, computerization and process automation are playing an important role in process control and optimization and in the maintenance of product quality and consistency characteristics. Bioprocessing represents the industrial practice of biotechnology and is multidisciplinary in nature, integrating the biological, chemical and engineering sciences. This book discusses the individual unit operations involved and describes a wide variety of important industrial bioprocesses. I am very grateful to Sanjay Thakur who assisted me in the collection of material for this book.

The effective sterilisation of any material or device to be implanted in or used in close contact with the human body is essential for the elimination of harmful agents such as bacteria. Sterilisation of biomaterials and medical devices reviews established and commonly used technologies alongside new and emerging processes.Following an introduction to the key concepts and challenges involved in sterilisation, the sterilisation of biomaterials and medical devices using steam and dry heat, ionising radiation and ethylene oxide is reviewed. A range of non-traditional sterilisation techniques, such as hydrogen peroxide gas plasma, ozone and steam formaldehyde, is then discussed together with research in sterilisation and decontamination of surfaces by plasma discharges. Sterilisation techniques for polymers, drug-device products and tissue allografts are then reviewed, together with antimicrobial coatings for 'self-sterilisation' and the challenge presented by prions and endotoxins in the sterilisation of reusable medical devices. The book concludes with a discussion of future trends in the sterilisation of biomaterials and medical devices.With its distinguished editors and expert team of international contributors, Sterilisation of biomaterials and medical devices is an essential reference for all materials scientists, engineers and researchers within the medical devices industry. It also provides a thorough overview for academics and clinicians working in this area. - Reviews established and commonly used technologies alongside new and emerging processes - Introduces and reviews the key concepts and challenges involved in sterilisation - Discusses future trends in the sterilisation of biomaterials and medical devices

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?

Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, by Gerald E. McDonnell, is a detailed and accessible presentation of the current methods of microbial control. Each major category, such as physical disinfection methods, is given a chapter, in which theory, spectrum of activity, advantages, disadvantages, and modes of action of the methods are thoroughly and clearly presented. Sufficient background on the life cycles and general anatomy of microorganisms is provided so that the reader who is new to microbiology will better appreciate how physical and chemical biocides work their magic on microbes. Other topics in the book include: Evaluating the efficacy of chemical antiseptics and disinfectants, and of physical methods of microbial control and sterilization. Understanding how to choose the proper biocidal product and process for specific applications. Classic physical and chemical disinfection methods, such as heat, cold, non-ionizing radiation, acids, oxidizing agents, and metals. Newer chemical disinfectants, including, isothiazolones, micro-and nano-particles, and bacteriophages as control agents. Antisepsis of skin and wounds and the biocides that can be used as antiseptics. Classic methods of physical sterilization, such as, moist heat and dry heat sterilization, ionizing radiation, and filtration, along with newer methods, including, the use of plasma or pulsed light. Chemical sterilization methods that use ethylene oxide, formaldehyde, or a variety of other oxidizing agents. A detailed look at the modes of action of biocides in controlling microbial growth and disrupting microbial physiology. Mechanisms that microorganisms use to resist the effects of biocides. The second edition of Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance is well suited as a textbook and is outstanding as a reference book for facilities managers and application engineers in manufacturing plants, hospitals, and food production facilities. It is also essential for public health officials, healthcare professionals, and infection control practitioners.