Sterile Processing of Pharmaceutical Products - Engineering Practice, Validation, Compliance in Regulated

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.

List of contents

Preface xiii
 
Acknowledgments xvii
 
1 Introduction 1
 
2 Sterilization 4
 
Steam Sterilization 5
 
Flash Sterilization 5
 
Low-Temperature Sterilization Technologies 6
 
Ethylene Oxide Gas Sterilization 6
 
Hydrogen Peroxide Gas Plasma 7
 
Disinfection and Surface Sterilization Using Peracetic Acid 7
 
Ionizing Radiation 8
 
Dry-Heat Sterilizers 8
 
Filtration 9
 
Microwave 9
 
Vaporized Hydrogen Peroxide (VHP(r)) 9
 
Ozone 9
 
Formaldehyde Steam 10
 
Gaseous Chlorine Dioxide 10
 
Vaporized Peracetic Acid 10
 
Infrared Radiation 10
 
Sterilization Cycle Verification 11
 
Monitoring 11
 
3 Sterile Manufacturing Facilities 15
 
4 Sanitary Process Piping and Equipment 17
 
QA Procedures 18
 
Standard Operating Procedures - cGMP Installations 19
 
Heat Exchangers 19
 
Sanitary Pumps 20
 
Sanitary Tanks 20
 
Instruments 21
 
Pressure Transmitter (Various Sources) 21
 
Temperature Transmitter (Various Sources) 21
 
Standard Operating Procedures - cGMP Installations 25
 
Surface Finish 30
 
Welding 32
 
Applicability 33
 
Process/Procedure 39
 
Records (General) 41
 
Records 44
 
Automatic Orbital Welding 47
 
Weld Acceptance Criteria for Automatic Orbital Weld Qualifications 47
 
5 Passivation 49
 
In-house Passivation Using Vats 51
 
Spot Passivation 53
 
Astro Pak UltraPass Gel Passivation 53
 
Alternative Process 54
 
Control of Passivated Items 57
 
Preparing, Testing, and Adjusting Cleaning and Passivation Chemicals (Passivation in Vats) 58
 
6 Chilled Water System 63
 
Process Description 65
 
Commissioning of HVAC 75
 
Installation Verification - X Ton Chiller System 78
 
SystemStartup - X Ton Chiller 81
 
Functional Testing - X Ton Chiller 82
 
7 Clean-In-Place (CIP) Systems 84
 
Life Cycle Requirements 86
 
Product and Process User Requirements 86
 
Process Quality Requirements 86
 
Process Parameter Requirements 87
 
Installation User Requirements 87
 
Operational Requirements 91
 
8 Computerized Automated Systems 95
 
Functional Requirement Specification 95
 
Process Automation System 95
 
EMS User Requirement Specification 96
 
Automation Overview 96
 
Software 97
 
Hardware 97
 
SCADA 97
 
Control Panels 97
 
Main Control Panel 97
 
Remote I/O Panels 98
 
Power Distribution Panels 98
 
Instrumentation Panels 98
 
System Functions 98
 
System Overview 98
 
Control Modules 99
 
Interfaces 99
 
User Interface (SCADA) 99
 
PAS System Overview 99
 
Graphical Screen Navigation 99
 
Client EMS Area Graphical Screens 99
 
Graphical Control Screens 99
 
Interfaces to Equipment 101
 
Interfaces to Other Systems 101
 
Ethernet Network 101
 
Nonfunctional Attributes 101
 
Power Failure Recovery 101
 
PLC Only Failure 101
 
HMI Only Failure 101
 
Network Only Failure 101
 
Maintainability 102
 
Backup and Recovery 102
 
Functional Requirement Specification 102
 
GLC Environmental Monitoring System 102
 
Automation Overview 103
 
System Components 104
 
Software 104
 
Hardwa

About the author

Sam A. Hout, PhD, MBA, is a Chartered Chemical Engineer, certified in business management by the American Production and Inventory Control Society (APICS), and a member of the International Society of Pharmaceutical Engineers (ISPE). Dr. Hout held the position of Senior Director of Engineering, project management, and technology process transfers at Siegfried Pharmaceuticals. Previously, he was Senior Manager of Engineering at TEVA Pharmaceuticals and Director of Operations at the HPLC company Phenomenex.

Summary

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.

Product details

• Authors: Sa Hout, Sam A Hout, Sam A. Hout
• Publisher: Wiley, John and Sons Ltd
• Languages: English
• Product format: Hardback
• Released: 31.12.2021
• EAN: 9781119802327
• ISBN: 978-1-119-80232-7
• No. of pages: 368
• Subjects: Natural sciences, medicine, IT, technology > Chemistry > Miscellaneous; Chemie, Arbeitssicherheit, pharmazeutische industrie, Prozesssteuerung, chemistry, Chemical Engineering, chemische Verfahrenstechnik, Chemical and Environmental Health and Safety, Arbeitssicherheit u. Umweltschutz i. d. Chemie, Pharmaceutical & Medicinal Chemistry, Pharmazeutische u. Medizinische Chemie, Process Engineering