Houson Process Understanding

For Scale-Up and Manufacture of Active Ingredients
1. Auflage 2011
ISBN: 978-3-527-63716-4
Verlag: Wiley-VCH
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 352 Seiten, E-Book

Process Understanding is the underpinning knowledge that allows the manufacture of chemical entities to be carried out routinely, robustly and to the required standard of quality. This area has gained in importance over the last few years, particularly due to the recent impetus from the USA`s Food and Drug Administration. This book covers the multidisciplinary aspects required for successful process design, safety, modeling, scale-up, PAT, pilot plant implementation, plant design as well the rapidly expanding area of outsourcing.

 

In discussing what process understanding means to different disciplines and sectors throughout a product`s life cycle, this handbook and ready reference reveals the factors important to the development and manufacture of chemicals. The book focuses on the fundamental scientific understanding necessary. for a smoother technical transfer between the disciplines, leading to more effective and effi cient process development and manufacturing. A range of case studies are used to exemplify and illustrate the main issues raised.

 

As a result, readers will appreciate that process understanding can deliver a real competitive advantage within the pharmaceuticals and fine chemicals industry. This book serves as an aid to meeting the stringent regulations required by the relevant authorities through demonstrable understanding of the underlying science.

Autoren/Hrsg.

Houson, Ian

Inhaltsverzeichnis

Preface

 

QUALIT Y BY DESIGN

History

Defining Product Design Requirements and Critical Quality Attributes

The Role of Quality Risk Management in QbD

Design Space and Control Strategy

Quality Systems

 

ROUTE AND PROCESS SELECTION

Introduction

Route Evaluation

Factors to Consider

Route Selection

Process Selection

Summary

 

CRITICAL STAGES OF SAFETY ASSESSMENT IN PROCESS DESIGN AND SCALE-UP

Reaction Safety Concepts

Pre-Laboratory Safety Studies

The Synergies of Safety and Optimization - Together

Establishing a Reliable Basis of Safety for Scale-Up

Flammability Hazards

Summary

 

UNDERSTANDING THE REACTION

Introduction

Process Complexity

Topics for Data Acquisition

Reaction Profiles

Reaction Pictures

Ionic Equilibria and Reaction Selectivity

Kinetics

Catalyzed Processes

The Rate-Determining Step

Mixing in Chemical Reactors

Mixing Theory

Multiphase Processes

Mass Transfer Theory

Mass Transfer and Mixing Requirements in Multiphase Systems

Concepts of Structure and Scale for Equipment Selection

Conclusion

 

USE OF MODELS TO ENHANCE PROCESS UNDERSTANDING

Introduction

The Process Characterization Elements of a Chemical Reaction

The Impact of Modeling

Understanding the Chemistry

Physical Rates (The Elements of Mass Transfer)

Summary and Outlook

 

SCALE-UP OF CHEMICAL REACTIONS

Introduction

Case Study - Batch Hydrogenation

Scale-Up of Stirred Tank Reactors (STRs)

Stirred Tank Scale-Up

Chemistry Effects in Scale-Up

Achieving Process Understanding for Reactor Scale-Up

Reactor Selection

Exploiting Process Understanding in Scale-Up

Conclusions

 

PROCESS UNDERSTANDING - CRYSTALLIZATION

Introduction

Crystallization Processes

Batch Crystallization Techniques

Process Control of Crystallization

Analytical Techniques for Product Characterization

Conclusions

 

KEY TECHNOLOGIES AND OPPORTUNITIES FOR INNOVATION AT THE DRUG SUBSTANCE - DRUG PRODUCT INTERFACE

Introduction

Opportunities for Innovation

Crystallization

Selected Manufacturing Technologies at the Drug Substance - Drug Product Interface

Analytical Techniques

Conclusions

 

PROCESS UNDERSTANDING REQUIREMENTS IN ESTABLISHED MANUFACTURE

Introduction

The Status Quo

Risk and Reward

Terms and Definitions

Process Understanding Requirements

Method Development and Installation

Statistical Process Control

Automation

Conclusion

 

PLANT DESIGN

Introduction

Developing Process Concept to Plant Concept

Regulations

Infrastructure Design

Portfolio Analysis and Asset Planning

 

CONTRACT MANUFACTURE

Introduction

Why Contract?

The Contractor

The Client

Technology Transfer

What Makes a Good Technical Package?

Client Process Understanding

Case Studies

Winning and Delivering the Project

Project Timing

Challenges of Multiproduct Plant Scheduling against an Uncertain Background

Conclusion

 

WHOLE PROCESS DESIGN

Process Understanding for Whole Process Design

Process Outcomes

Organization of the Design Activity

Risk and Uncertainty in WPD

Whole Process Representations

Decision Making in WPD

Summary

Über Autor(innen)

Ian Houson gained a 1st class BSc. Hons in Chemistry and Oceanography from the University of Southampton, he completed his doctorate at the University of Oxford with Prof. John Brown FRS in organic chemistry. Ian then joined Zeneca, which became Avecia and finally NPIL Pharma where he was Chemical Process R&D Manager for the site. His main roles were invention of new routes, scale-up and manufacturing support for the contract manufacturing of agrochemicals and pharmaceuticals at the kg`s to 10`s tonnes scale. Moving to Britest Ltd. in 2007 as a senior innovation specialist, Ian was involved in developing new tools and methodologies

for innovative process development and manufacturing, facilitating manufacturing process improvement studies and collaborative research in a number of European projects. In March 2011 Ian joined Giltech Ltd, Ayr, Scotland as a Senior Scientist involved in development of novel biodegradable and slow release technologies across a wide range of chemicals and medical device applications. His responsibilities include product development, supporting joint development projects and intellectual property aspects.