【正文】 ation, and handling of API. The following list is provided to indicate the diversity of some mon examples. 1. Frozen in cryovessels, ranging in size from 50 to 300 L 2. Frozen in small containers, ranging in size from 1 to 20 L 3. As liquid in small containers, ranging in size from 1 to 20 L 4. As powder in canisters, ranging in size from 1 to 50 kg Weighing and dispensing can occur for either sterile or nonsterile material. It is remended that sterile material be dispensed in an isolator to prevent contamination. The isolator should be fitted with a rapid decon antechamber to facilitate the addition of product and containers to be dispensed.ASEPTIC MANUFACTURING FACILITY DESIGN 5 EQUIPMENT W ASH I COMPONENT PREP EQUIPMENT W ASH / COMPONENT PREP CONVENTIONAL t RABS OPERATIONS ISOLATOR TECHNOLOGY OPERATKNS Figure 1 {See color insert) Weigh and dispense. Nonsterile material should be protected by HEPA filtration during dispensing operations to prevent addition of particulate. Containers of API should not be opened for sampling prior to use in the formulation area. Therefore, it is remended that ail lot of API containe。D Microbiology, Hospira, Inc., Lake Forest, Illinois, . Bob Helt Jacobs Engineering Group, Inc., Conshohocken, Pennsylvania, . Beth Holden Jacobs Engineering Group, Inc., Conshohocken, Pennsylvania, . Maik W. Jornitz Sartorius Stedim North America, Inc., Bohemia, New York, . Joseph J. Manfredi GMP Systems, Inc., Fairfield, New Jersey, . Christine Martin Abbott GmbH amp。) revise the text with current and emerging sterile product development and manufacturing science and (ii) maintain the high standard of quality the readers expect. The third edition not only reflects enhanced content in all the chapters, but also more than half of the chapters are new underscoring the rapidly advancing technology. We have divided the volumes into logical subunits—volume 1 addresses formulation and packaging aspects。s instructions and the appropriate best practice guidelines. Because of the rapid advances in medical science, any information or advice on dosages, procedures, or diagnoses should be independently verified. This book does not indicate whether a particular treatment is appropriate or suitable for a particular individual. Ultimately it is the sole responsibility of the mt^ica 】 professional to make his or her own professional judgements, so as appropriately to advise and treat patients. Save for death or personal injury caused by the publisher39。s medical history, relevant manufacturer39。 tradition. Their oversight of this third edition is work that their mentor would be highly pleased and proud of. From 29 chapters in the second edition to 43 chapters in this new edition, this threevolume series prehensively covers both the traditional subjects in parenteral science and technology as well as new and expanded subjects. For example, separate chapter topics in this edition not found in previous editions include solubility and solubilization, depot delivery systems, biophysical and biochemical characterization of peptides and proteins, container closure integrity testing, water systems, endotoxin testing, focused chapters on different sterilization methods, risk assessment in aseptic processing, visual inspection, advances in injection devices, RNAi delivery, regulatory considerations for excipients, techniques to evaluate pain on injection, product specifications, extractables and leachables, process analytical technology, and quality by design. The editors have done an outstanding job of convincing so many top experts in their fields to author these 43 chapters. The excellent reputations of the authors and editors of this book will guarantee superb content of each chapter. There is no other book in the world that covers the breadth and depth of parenteral science and technology better than this one. In my opinion, the editors have achieved their primary objectives—publishing a book that contains current and emerging sterile product development and manufacturing information, and maintaining the high standard of quality that readers would expect. Michael ]. Akers Baxter BioPhamia Solutions Bloomington, Indiana, .This page intentionally left blankPreface Pharmaceutical Dosage Forms: Parenteral Medications was originally published in 1984 and immediately accepted as a definitive reference in academic institutions and the pharmaceutical industry. The second edition was published in 1993. The ensuing years have produced incredible technological advancement. C lassic smallmolecule drugs are now plemented by plex molecules such as monoclonal antibodies, antibody fragments, aptamers, antisense, RNAi therapeutics, and DNA vaccines. There have been significant innovations in delivery devices, analytical techniques, insilico modeling, and manufacturing and control technologies. In addition, the global regulatory environment has shifted toward greater emphasis on sciencebased risk assessment as evidenced by the evolving cGMPs, quality by design (QbD), process analytical technology (PAT), continuous processing, real time release, and other initiatives. The rapidly changing landscape in the parenteral field was the primary reason we undertook the challenging task of updating the three volumes. Our objectives were to (/39。 Associates, Belle Mead, New Jersey, . D. Scott Aldrich Ultramikro, LLC, Richland, Michigan, . Anne F. Booth Booth Scientific, Inc., Hendersonville, North Carolina, . Mark Caldwell Jacobs Engineering Group, Inc., Conshohocken, Pennsylvania, . Michael E. Dawson Associates of Cape Cod, Inc., Falmouth, Massachusetts, . Donald A. Eisenhauer Abbott Laboratories, North Chicago, Illinois, . Barry P. Fairand Sterigenics International, Dublin, Ohio, . Larry A. Gatlin PK, LLC, Groton, Connecticut, . Deborah Havlik Ram