1st Edition

Sterile Manufacturing Regulations, Processes, and Guidelines

By Sam A. Hout Copyright 2022
    206 Pages 14 B/W Illustrations
    by CRC Press

    This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH, emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products.


    Additionally, this book provides the fundamentals of aseptic techniques, quality by design, risk assessment, and management in support of sterile operations applications. It creates a link to the implementation of business practices in drug manufacturing and healthcare and forms a correlation between design strategies including a step-by-step process to ensure reliability, safety, and efficacy of healthcare products for human and animal use. The book also provides a connection between drug production and regulated applications by offering a review of the basic elements of sterile processing, and how to remain viable with solid strategic planning.


    The book is a concise reference for professionals and learners in the field of sterile operations that governs primarily, pharmaceutical and medical device space, but can also extend to food and cosmetics that require clean (aseptic) manufacturing applications. It also helps compounding pharmacists and GMP inspectors and auditors.

    Chapter 1 Introduction

    Chapter 2 Data Integrity Compliance

    Chapter 3 Risk-Based Life Cycle Management

    Chapter 4 FMEA Manufacturing Procedure

    Chapter 5 Classified Areas

    Chapter 6 Sterile Manufacturing Facilities

    Chapter 7 Personnel behaviors, Personal Protective Equipment (PPE), and

    Process Flow

    Chapter 8 Quality Approach for Systems Validation

    Chapter 9 Dedicated Facilities

    Chapter 10 Contamination

    Chapter 11 Containment

    Chapter 12 Suppliers

    Chapter 13 Single-Use Technologies (SUT)

    Chapter 14 Master Qualification Plan

    Chapter 15 Water For Injection (WFI)

    Chapter 16 Integrated Facility Design

    Chapter 17 Sterile Techniques

    Chapter 18 Compliance

    Chapter 19 Controls

    Chapter 20 Barriers and Isolators

    Chapter 21 Quality Risk Management

    Chapter 22 Equipment Qualification (EQ)

    Chapter 23 Process Validation

    Chapter 24 Change Control

    Chapter 25 Analytical Testing of Raw Material Quality

    Chapter 26 Product Life Cycle

    Chapter 27 Quality by Design (QbD)

    Chapter 28 Sterilization

    Chapter 29 Cleaning Validation

    Chapter 30 Lyophilization


    Dr. Sam A. Hout is a chartered chemical engineer and certified in business management by the American Production and Inventory Control Society (APICS). He also is a member of the International Society of Pharmaceutical Engineers (ISPE) and specializes in process engineering and business process improvement. He received his education and training in the UK (Ph.D. Chemical Engineering, University of Bath) and in the United States (MBA, University of California). For the past 20 years in aseptic manufacturing, he held the position of Sr. Director of Engineering, project management, and technology process transfers at Siegfried Pharmaceuticals. Previously, he held the position of Sr. Manager of Engineering at TEVA Pharmaceuticals, parenteral medicines in Irvine, California. These specialty divisions produced sterile injectable drugs for hospital institutional markets worldwide.