Sterile Processing of Pharmaceutical Products
Sterile Processing of Pharmaceutical Products

Author: Sam A. Hout

Publisher: John Wiley & Sons

Published: 2022-01-26

Total Pages: 372

ISBN-13: 1119802326

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Describes the methodologies and best practices of the sterile manufacture of drug products Thoroughly trained personnel and carefully designed, operated, and maintained facilities and equipment are vital for the sterile manufacture of medicinal products using aseptic processing. Professionals in pharmaceutical and biopharmaceutical manufacturing facilities must have a clear understanding of current good manufacturing practice (cGMP) and preapproval inspection (PAI) requirements. Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments provides up-to-date coverage of aseptic processing techniques and sterilization methods. Written by a recognized expert with more than 20 years of industry experience in aseptic manufacturing, this practical resource illustrates a comprehensive approach to sterile manufacturing engineering that can achieve drug manufacturing objectives and goals. Topics include sanitary piping and equipment, cleaning and manufacturing process validation, computerized automated systems, personal protective equipment (PPE), clean-in-place (CIP) systems, barriers and isolators, and guidelines for statistical procedure. Offering authoritative guidance on the key aspects of sterile manufacturing engineering, this volume: Covers fundamentals of aseptic techniques, quality by design, risk assessment and management, and operational requirements Addresses various regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH Provides techniques for systematic process optimization and good manufacturing practice Emphasizes the importance of attention to detail in process development and validation Features real-world examples highlighting different aspects of drug manufacturing Sterile Processing of Pharmaceutical Products: Engineering Practice, Validation, and Compliance in Regulated Environments is an indispensable reference and guide for all chemists, chemical engineers, pharmaceutical professionals and engineers, and other professionals working in pharmaceutical sciences and manufacturing.

Handbook of Aseptic Processing and Packaging
Handbook of Aseptic Processing and Packaging

Author: Jairus R. D. David

Publisher: CRC Press

Published: 2022-09-07

Total Pages: 702

ISBN-13: 1000631095

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Nine years have passed since the second edition of the Handbook of Aseptic Processing and Packaging was published. Significant changes have taken place in several aseptic processing and packaging areas. These include aseptic filling of plant-based beverages for non-refrigerated shelf-stable formats for longer shelf life and sustainable packaging along with cost of environmental benefits to leverage savings on energy and carbon footprint. In addition, insight into safe processing of particulates using two- and three-dimensional thermal processing followed by prompt cooling is provided. In the third edition, the editors have compiled contemporary topics with information synthesized from internationally recognized authorities in their fields. In addition to updated information, 12 new chapters have been added in this latest release with content on Design of the aseptic processing system and thermal processing Thermal process equipment and technology for heating and cooling Flow and residence time distribution (RTD) for homogeneous and heterogeneous fluids Thermal process and optimization of aseptic processing containing solid particulates Aseptic filling and packaging equipment for retail products and food service Design of facility, infrastructure, and utilities Cleaning and sanitization for aseptic processing and packaging operations Microbiology of aseptically processed and packaged products Risk-based analyses and methodologies Establishment of "validated state" for aseptic processing and packaging systems Quality and food safety management systems for aseptic and extended shelf life (ESL) manufacturing Computational and numerical models and simulations for aseptic processing Also, there are seven new appendices on original patents, examples of typical thermal process calculations, and particulate studies—single particle and multiple-type particles, and Food and Drug Administration (FDA) filing The three editors and 22 contributors to this volume have more than 250 years of combined experience encompassing manufacturing, innovation in processing and packaging, R&D, quality assurance, and compliance. Their insight provides a comprehensive update on this rapidly developing leading-edge technology for the food processing industry. The future of aseptic processing and packaging of foods and beverages will be driven by customer-facing convenience and taste, use of current and new premium clean label natural ingredients, use of multifactorial preservation or hurdle technology for maximizing product quality, and sustainable packaging with claims and messaging.

Whisky and Other Spirits
Whisky and Other Spirits

Author: Graham Stewart

Publisher: Academic Press

Published: 2021-09-22

Total Pages: 598

ISBN-13: 0323853609

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Whisky and Other Spirits: Technology, Production and Marketing, Third Edition continues to provide details from raw materials to the finished product, including production, packaging and marketing. It focuses on the science and technology of the process as well as the environment in which it is produced. Today, environmental concerns and sustainability of products has taken on a new level of importance. Traditional ways of packaging and marketing have also changed dramatically in recent years as the technology of packaging has moved from a staid bottle industry to spirit products that cross traditional beverage categories and packaging. This new edition provides the latest changes in industry and the beverages market. All chapters are updated, with new chapters added to help improve research and development, and to increase production of not only whiskey but other spirits such as gin and rum and white spirits. This new edition also discusses trendy reduced alcohol and no alcohol products. - Presents a detailed look into current global situation for whisky and spirits production - Highlights craft distilling and the challenges craft distillers face by presenting the art of spirit production in clear detail - Presents insights into how marketing has changed for distilled products, with an emphasis on new mobile technologies

Handbook of Valves and Actuators
Handbook of Valves and Actuators

Author: Brian Nesbitt

Publisher: Elsevier

Published: 2011-04-19

Total Pages: 571

ISBN-13: 0080549284

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Industries that use pumps, seals and pipes will also use valves and actuators in their systems. This key reference provides anyone who designs, uses, specifies or maintains valves and valve systems with all of the critical design, specification, performance and operational information they need for the job in hand. Brian Nesbitt is a well-known consultant with a considerable publishing record. A lifetime of experience backs up the huge amount of practical detail in this volume.* Valves and actuators are widely used across industry and this dedicated reference provides all the information plant designers, specifiers or those involved with maintenance require* Practical approach backed up with technical detail and engineering know-how makes this the ideal single volume reference* Compares and contracts valve and actuator types to ensure the right equipment is chosen for the right application and properly maintained