Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceut...

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 for aseptic processing that will markedly reduce the level of contamination risk for sterile products and includes coverage on:The...

Additive Manufacturing (AM) technologies are developing impressively and are expected to bring about the next revolution. AM is gradually replacing traditional manufacturing methods in some applications because of its unique properties of customisability and versatility. This book provides a very comprehensive and updated text about different types of AM technologies, their respective advantages, shortcomings and potential applications.3D Printing and Additive Manufacturing: Principles and...

Rapid prototyping (RP) has revolutionized how prototypes are made and small batch manufacturing is carried out. With rapid prototyping, the strategies used to produce a part change a number of important considerations and limitations previously faced by tool designers and engineers. Now in its third edition, this textbook is still the definitive text on RP. It covers the key RP processes, the available models and specifications, and their principles, materials, advantages and disadvantages...

Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing fieldBiomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical manufacturing facilities is difficult to find in published literature—...

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapte...

This key document, produced by the BFS IOA, outlines important aspects on operation of BFS technology to ensure both compliance with cGMP regulations and the production of drug products of the appropriate quality, safety and efficacy. The Points to Consider document provides recommendations specific to the operation of Blow-Fill-Seal technology for the manufacture of sterile pharmaceuticals and liquid medical devices. One of the aims of this document is to define the minimum standards expe...

Research institutions have or are planning to build, expand and renovate animal research facilities to keep up with the demands of biomedical research caused in part by growth in the use of genetically altered rodents and the upsurge of research in infectious diseases. Properly designed facilities greatly facilitate effective management and high-quality day-to-day animal care that is required to optimally support animal research and testing. There are multiple solutions to address the myri...

The only comprehensive and authoritative reference guide to the ASME Bioprocessing Piping and Equipment (BPE) standardThis is a companion guide to the ASME Bioprocessing Piping and Equipment (BPE) Standard and explains what lies behind many of the requirements and recommendations within that industry standard. Following an introductory narrative to the Standard's early history, industry related codes and standards are explained; the design and engineering aspects c...

Developed in conjunction with the International Ultraviolet Association, U ltraviolet Disinfection for Wastewater: Low-Dose Application Guidance for Secondary and Tertiary Discharges serves as a guide for consultants, wastewater utilities, and operators and provides introductory information on the advantages (and disadvantages) of UV disinfection compared to other commonly used technologies. It also provides valuable information to regulatory agencies who review applications for t...

A State-of-the-Art Guide to Biomedical Engineering and Design Fundamentals and ApplicationsThe two-volume Biomedical Engineering and Design Handbook, Second Edition, offers unsurpassed coverage of the entire biomedical engineering field, including fundamental concepts, design and development processes, and applications. This landmark work contains contributions on a wide range of topics from nearly 80 leading experts at universities, medical centers, and c...

Written by a researcher with experience designing, establishing, and validating biological manufacturing facilities worldwide, this is the first comprehensive introduction to disposable systems for biological drug manufacturing. It reviews the current state of the industry; tackles questions about safety, costs, regulations, and waste disposal; and guides readers to choose disposable components that meet their needs. This practical manual covers disposable containers, mixing systems, biore...