Continuous pharmaceutical processing

by El Hagrasy, Arwa Litster, Jim Nagy, Zoltan K.

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Title Statements

Full title :Continuous pharmaceutical processing / Zoltan K Nagy, Arwa El Hagrasy, Jim Litster, editors.

Summary

Continuous pharmaceutical manufacturing is currently receiving much interest from industry and regulatory authorities, with the joint aim of allowing rapid access of novel therapeutics and existing medications to the public, without compromising high quality. Research groups from different academic institutions have significantly contributed to this field with an immense amount of published research addressing a variety of topics related to continuous processing. The book is structured to have individual chapters on the different continuous unit operations involved in drug substance and drug product manufacturing. A wide spectrum of topics are covered, including basic principles of continuous manufacturing, applications of continuous flow chemistry in drug synthesis, continuous crystallization, continuous drying, feeders and blenders, roll compaction and continuous wet granulation. The underlying theme for each of these chapters is to present to the reader the recent advances in modeling, experimental investigations and equipment design as they pertain to each individual unit operation. The book also includes chapters on quality by design (QbD) and process analytical technology (PAT) for continuous processing, process control strategies including new concepts of quality-by-control (QbC), real-time process management and plant optimization, business and supply chain considerations related to continuous manufacturing as well as safety guidelines related to continuous chemistry. A separate chapter is dedicated to discussing regulatory aspects of continuous manufacturing, with description of current regulatory environment quality/GMP aspects, as well as regulatory gaps and challenges. Our aim from publishing this book is to make it a valuable reference for readers interested in this topic, with a desire to gain a fundamental understanding of engineering principles and mechanistic studies utilized in understanding and developing continuous processes. In addition, our adva nced readers and practitioners in this field will find that the technical content of Continuous Pharmaceutical Processing is at the forefront of recent technological advances, with coverage of future prospects and challenges for this technology.

Edition Statements

Publication Date:2020.

Publication Statements

Publisher(s):Springer
Place of Publication:Cham
Language:eng
Publication Date:2020.

Notes

Includes index.

The Physical Object

Description:1 online resource

Edition Identifiers

ISBN:9783030415242, 3030415244
oclc:on1158281967
LC Classification:HD9665.5
Dewey Decimal:338.4/76151

Intro -- Preface -- Contents -- Chapter 1: Basic Principles of Continuous Manufacturing -- 1.1 Introduction -- 1.2 General Characteristics of Continuous Processes -- 1.3 Multiunit Continuous Processes -- 1.4 Requirements for Effective Continuous Processing -- 1.5 Comparative Assessment of Batch and Continuous Operating Modes -- References -- Chapter 2: Continuous Reactors for Pharmaceutical Manufacturing -- 2.1 Introduction -- 2.2 Superheated PFR in Oven for Imidazole Cyclization -- 2.3 Pulsating Flow Coiled Tube PFR for Hydroformylation with Solids Precipitate

2.4 Vertical Pipes-in-Series PFR for Reductive Amination -- 2.5 Superheated PFR in Steam Shell for Thermal EE Deprotection -- 2.6 CSTRs-in-Series for Schotten-Baumann with Two Liquid Phases -- 2.7 Intermittent Flow Stirred Tank Reactor for Suzuki Cross-Coupling with Two Liquid Phases -- 2.8 CSTRs-in-Series for Barbier Grignard, Quench, and Neutralization to Minimize Racemization -- 2.9 Low-Pressure Disposable Coiled Tube PFR for Highly Potent Compound -- 2.10 Understanding the Real Reaction Temperature in a PFR -- References

Chapter 3: Understanding Residence Time, Residence Time Distribution, and Impact of Surge Vessels …

Subjects

Indústria farmacèutica Industrie pharmaceutique -- Gestion Llibres electrònics MEDICAL -- Pharmacy Pharmaceutical industry -- Management Pharmaceutical industry -- Technologica… Pharmaceutical technology Tecnologia farmacèutica