Sterile processing of pharmaceutical products : engineering practice, validation, and compliance in regulated environments / Sam A. Hout.

Format:

Book

Author/Creator:

Hout, Sam A., author.

Language:

English

Subjects (All):

Pharmaceutical industry.

Physical Description:

1 online resource (371 pages)

Place of Publication:

Hoboken, NJ : John Wiley & Sons, Inc., 2022.

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.

Contents:

Cover

Title Page

Copyright

Contents

Preface

Acknowledgments

Chapter 1 Introduction

Chapter 2 Sterilization

Steam Sterilization

Flash Sterilization

Low‐Temperature Sterilization Technologies

Ethylene Oxide Gas Sterilization

Hydrogen Peroxide Gas Plasma

Disinfection and Surface Sterilization Using Peracetic Acid

Ionizing Radiation

Dry‐Heat Sterilizers

Filtration

Microwave

Vaporized Hydrogen Peroxide (VHP®)

Ozone

Formaldehyde Steam

Gaseous Chlorine Dioxide

Vaporized Peracetic Acid

Infrared Radiation

Sterilization Cycle Verification

Monitoring

Chapter 3 Sterile Manufacturing Facilities

Chapter 4 Sanitary Process Piping and Equipment

QA Procedures

Standard Operating Procedures - cGMP Installations

Heat Exchangers

Sanitary Pumps

Sanitary Tanks

Instruments

Pressure Transmitter (Various Sources)

Temperature Transmitter (Various Sources)

Surface Finish

Welding

Applicability

Process/Procedure

Records (General)

Records

Automatic Orbital Welding

Weld Acceptance Criteria for Automatic Orbital Weld Qualifications

Chapter 5 Passivation

In‐house Passivation Using Vats

Spot Passivation

Astro Pak UltraPass Gel Passivation

Alternative Process

Control of Passivated Items

Preparing, Testing, and Adjusting Cleaning and Passivation Chemicals (Passivation in Vats)

Chapter 6 Chilled Water System

Process Description

Commissioning of HVAC

Installation Verification - X Ton Chiller System

System Startup - X Ton Chiller

Functional Testing - X Ton Chiller

Chapter 7 Clean‐In‐Place (CIP) Systems

Life Cycle Requirements

Product and Process User Requirements

Process Quality Requirements

Process Parameter Requirements.

Installation User Requirements

Operational Requirements

Chapter 8 Computerized Automated Systems

Functional Requirement Specification

Process Automation System

EMS User Requirement Specification

Automation Overview

Software

Hardware

SCADA

Control Panels

Main Control Panel

Remote I/O Panels

Power Distribution Panels

Instrumentation Panels

System Functions

System Overview

Control Modules

Interfaces

User Interface (SCADA)

PAS System Overview

Graphical Screen Navigation

Client EMS Area Graphical Screens

Graphical Control Screens

Interfaces to Equipment

Interfaces to Other Systems

Ethernet Network

Nonfunctional Attributes

Power Failure Recovery

PLC Only Failure

HMI Only Failure

Network Only Failure

Maintainability

Backup and Recovery

GLC Environmental Monitoring System

System Components

Gateways

GLC EMS Area Graphical Screen

Global Logistics Center (GLC) Environmental Monitoring System

Wireless Connections

Software Module Design Specification

PAS System Overview Screen

Interfaces to Equipment.

Interfaces to Other Systems

Software Design Specification

Prosoft Configuration

Enabling and Disabling of the Gateway Default Server Interface

Temperature Sensor Settings

Humidity Sensor Settings

Continuous Logic

Module Classes and Control Modules

Virtual Differential Pressure Alarm Disable

Room Condition Indication

Navigation Links

Alarm Daily Report

WFI Still Equipment Module Class

WFI Silo Equipment Module Class

EM&amp

uscore

SILO

WFI Primary Loop Equipment Module Class

PRIM&amp

LOOP

WFI Supply Header Equipment Module Class

HEADER

Electrical - Controls Equipment Specifications

Documentation

Drives/Motors

Chapter 9 Personal Protective Equipment (PPE) and Process Flow

Chapter 10 Sterile Aseptic Processing

Chapter 11 Integrated Facility Design

Case Study

Issue

Root Cause

Corrective Action

Preventive Actions

Chapter 12 Barriers and Isolators

Isolator Design Considerations

Chapter 13 Guidelines for Statistical Procedure

Process Capability Analysis

Long‐term Studies

Acceptance Sampling

Attribute and Variable Sampling Plans

Variable Sampling Plans - ANSI Z1.9

Normality

Transformation of Non‐normal Data (Normalization)

Protocol Sampling

Failure Mode and Effect Analysis (FMEA)

Calculating or Recalculating Control Limits

Chapter 14 Calibration

Contingency Plan/Disaster Recovery

Chapter 15 Cleaning Validation

New Products and Product Changes

Cleaning Processes and Changes

Risk Assessment/Matrix Approach

Matrix Development.

Cleaning Processes (Manual and Automated)

CPP/CQA

Cleaning Validation Life Cycle - Cleaning Method Development

Strategy for Process Controls

Worst‐Case Identification - Product/Component

Equipment

Validation Tests/Inspections - Visual Inspection

Chemical Testing

Microbiological Testing

Endotoxin Testing

Sampling Methods

Direct Swab Sampling

Rinse Sampling

Coupon Testing

Sampling Sites

Acceptance Criteria

Residual Levels

Endotoxin Levels

Microbiological Levels

Cleaning Agents/Sanitizer Validation Studies

Hold Time Development

Dirty Hold Time

Clean Hold Time

Additional Hold Times/Cleaning Frequencies

Continuous Process Verification

Failure Investigations

Chapter 16 Validation of Filling Equipment

Chapter 17 Manufacturing Process Validation

Stage 2 - Process Qualification

Appendix A Installation Test Plans

Appendix B Operational Tests Plans

Appendix C WFI Turbulence Flow Requirements

Appendix D Water For Injection (WFI) - Design Requirements

Specifications

Product Description

Operating Ranges

Material of Construction

Metallics

Plastics

Elastomers

Glass

Welding Requirements

Construction Requirements

Lubrication Requirements

Electrical Requirements

Safety Requirements

Process Constraints and Limitations

Process Control System

Operator Interface

Power Loss and Recovery

Cleaning and Sanitizing

Maintenance Requirements

Training and Documentation Requirements

Appendix E Solution Transfer System (STS) - Design Requirements

System Description

Bulk Powder Handling System

Glossary

Nomenclature

References

Further Reading

Index

EULA.

Notes:

Description based on print version record.

Other Format:

Print version: Hout, Sam A. Sterile Processing of Pharmaceutical Products

ISBN:

9781119802327

9781119802341

1119802342

9781119802358

1119802350

9781119802334

1119802334

OCLC:

1291316876