Pharmaceutical Process Engineering Volume 195 Drugs and the Pharmaceutical Sciences 2nd Edition by Anthony J Hickey, David Ganderton ISBN 1420084755 9781420084757

Pharmaceutical Process Engineering Volume 195 Drugs and the Pharmaceutical Sciences 2nd Edition by Anthony J Hickey, David Ganderton – Ebook PDF Instant Download/Delivery: 1420084755, 9781420084757
Full download Pharmaceutical Process Engineering Volume 195 Drugs and the Pharmaceutical Sciences 2nd Edition after payment

Product details:

ISBN 10: 1420084755 
ISBN 13: 9781420084757
Author: Anthony J Hickey, David Ganderton

With step-by-step methods of drug production and knowledge of major unit operations and key concepts of pharmaceutical engineering, this guide will help to improve communication among the varied professionals working in the pharmaceutical industry. Key features: REVISION OF A BESTSELLER – Updates include recent advances in the field to keep pharmac

Pharmaceutical Process Engineering Volume 195 Drugs and the Pharmaceutical Sciences 2nd Table of contents:

Part I: Fundamentals of Pharmaceutical Process Engineering

• Chapter 1: Introduction to Pharmaceutical Process Engineering

  • The Role of Process Engineering in Pharmaceutical Manufacturing

  • Overview of the Drug Discovery and Development Process

  • Pharmaceutical Product Categories (APIs, Dosage Forms, Biologics)

  • Key Regulatory Bodies and Requirements (FDA, EMA, ICH)

  • Good Manufacturing Practices (GMP) and Quality by Design (QbD)

• Chapter 2: Basic Engineering Principles for Pharmaceutical Processes

  • Mass and Energy Balances

  • Fluid Mechanics (Flow, Pumping, Mixing)

  • Heat Transfer (Conduction, Convection, Radiation, Heat Exchangers)

  • Mass Transfer (Diffusion, Absorption, Distillation)

• Chapter 3: Pharmaceutical Materials Science

  • Properties of Pharmaceutical Solids (Crystallinity, Amorphous State, Polymorphism)

  • Powder Mechanics and Granular Materials

  • Properties of Liquids and Solutions

  • Excipients and Their Functionality

Part II: Unit Operations in Pharmaceutical Manufacturing

• Chapter 4: Size Reduction and Enlargement

  • Milling and Micronization Techniques

  • Granulation (Wet Granulation, Dry Granulation)

  • Spheronization

  • Particle Size Analysis

• Chapter 5: Mixing and Blending

  • Principles of Mixing (Solids, Liquids, Multiphase Systems)

  • Types of Mixers and Blenders

  • Scale-Up Considerations

• Chapter 6: Separation Processes

  • Filtration (Microfiltration, Ultrafiltration, Sterile Filtration)

  • Centrifugation

  • Crystallization and Precipitation

  • Chromatography (for purification of APIs and biologics)

• Chapter 7: Drying Processes

  • Fundamentals of Drying

  • Convection Drying (Fluid Bed, Tray Dryers)

  • Conduction Drying (Vacuum Dryers)

  • Freeze Drying (Lyophilization)

  • Spray Drying

• Chapter 8: Sterilization and Aseptic Processing

  • Principles of Sterilization (Heat, Filtration, Radiation, Gas)

  • Validation of Sterilization Processes

  • Cleanroom Technology and Design

  • Aseptic Filling Operations

Part III: Dosage Form Manufacturing

• Chapter 9: Solid Dosage Forms: Tablets and Capsules

  • Tablet Compression (Direct Compression, Wet/Dry Granulation)

  • Tablet Coating (Film Coating, Enteric Coating)

  • Capsule Filling

  • Quality Control for Solid Dosage Forms

• Chapter 10: Liquid and Semisolid Dosage Forms

  • Solutions, Suspensions, Emulsions

  • Ointments, Creams, Gels

  • Formulation and Manufacturing Challenges

  • Filling and Packaging for Liquids/Semisolids

• Chapter 11: Parenteral and Biotechnological Products

  • Formulation of Injectables

  • Sterile Manufacturing of Biologics

  • Upstream and Downstream Processing for Biopharmaceuticals

  • Cell Culture and Fermentation Principles

  • Gene and Cell Therapy Manufacturing (Basic Introduction)

Part IV: Process Design, Control, and Quality

• Chapter 12: Process Design and Scale-Up

  • Process Flow Diagrams (PFDs) and Piping and Instrumentation Diagrams (P&IDs)

  • Pilot Plant Operations

  • Scale-Up Principles and Challenges

  • Process Intensification

• Chapter 13: Process Control and Automation

  • Instrumentation and Sensors

  • Control Systems (PID, Advanced Control)

  • Data Acquisition and Management

  • Automation and Robotics in Pharma Manufacturing

• Chapter 14: Validation and Qualification

  • Validation Master Plan

  • Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)

  • Process Validation

  • Cleaning Validation

• Chapter 15: Quality Risk Management and Process Analytical Technology (PAT)

  • ICH Q9 (Quality Risk Management)

  • ICH Q10 (Pharmaceutical Quality System)

  • Introduction to PAT (Real-time Monitoring and Control)

  • Data Integrity in Pharmaceutical Manufacturing

People also search for Pharmaceutical Process Engineering Volume 195 Drugs and the Pharmaceutical Sciences 2nd:

pharmaceutical process engineering
    
pharmaceutical process engineering pdf
    
pharmaceutical process engineering jobs
    
pharmaceutical process engineering and scale-up principles pdf
    
pharmaceutical process engineering course

 

 

 

 

 

Tags: Anthony J Hickey, David Ganderton, Pharmaceutical, Engineering