Sam A. Hout

Sterile Processing of Pharmaceutical Products (eBook, ePUB)

Engineering Practice, Validation, and Compliance in Regulated Environments

• Format: ePub

Produktbeschreibung

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.

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Produktdetails

• Verlag: Wiley
• Seitenzahl: 368
• Erscheinungstermin: 31. Dezember 2021
• Englisch
• ISBN-13: 9781119802341
• Artikelnr.: 63271758

Autorenporträt

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.

Inhaltsangabe

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