Cleanroom Contamination Prevention & Control: A Practical Guide to the Science Regulatory Requirements

New Title – to be published in November

Editors: Ziva Abraham and Morgan Polen

ISBN:  ebook – 978-1-917195-22-5    500pp    £240
ISBN:  Hardback – 978-1-917195-23-2   500pp    £270

This second edition of “Cleanroom Contamination Prevention & Control: A Practical Guide to the Science” follows on from the first edition of 2021.  This new edition takes a more holistic and comprehensive approach to contamination control, introducing several new chapters that were not included in the first edition. It also provides expanded coverage of barrier systems, including Restricted Access Barrier Systems (RABS) and isolators, through dedicated chapters and practical case studies.

A central focus of this edition is the identification of contamination control blind spots that are frequently overlooked in paper-based risk assessments. The goal is to help readers recognize that contamination control is a science grounded in the evaluation of real-world risks, rather than merely a documentation or compliance exercise.

The text brings together practical industry experience, scientific principles, and current regulatory expectations in a manner not readily available elsewhere. It is intended to serve as a well-organized, comprehensive, and highly practical resource for identifying, understanding, and controlling contamination risks across pharmaceutical and life-science operations.

Ziva Abraham has over 35 years of academic, research, clinical, and industrial experience in Microbiology, and Quality Assurance. Ziva has received her Master’s Degree in Microbiology and has conducted research on developing Microbial Insecticides using entomogenous bacteria and fungi towards her PhD degree.

She worked as a clinical scientist and established clinical laboratory systems in Israel. In this capacity Ziva evaluated the first automated microbial identification system, introduced new technologies for HIV testing, and rapid methods into the group of laboratories she helped  establish for Maccabi Medical. Her laboratory system conducted clinical testing in microbiology, chemistry, parasitology, hematology and immunology. She is a passionate microbiologist and mycologist and provides training worldwide on various microbiology and contamination control topics. Her clinical experience helps her evaluate and teach the clinical implications of microbial contamination to patients.

Ziva started Microrite in 1998 as an independent microbiology consultant. She used her extensive research experience with fungi and clinical organisms and their impact on human health to build an internationally  renowned contamination control team of experts. Her team consists of facilities, cleanroom, airflow, static charge, validation, quality and microbiology professionals with practical knowledge in their field and involvement in industry standards and guidance organizations. Ziva’s team work congruently to resolve client issues, prevent contamination through design and help making safe products for human and veterinary use.

Morgan Polen is a subject matter expert in the field of contamination control, airflow visualization and particle monitoring in cleanrooms.  He has over 35 Years of industry experience working in cleanrooms in all industries.  Morgan’s Technical Leadership is as follows:

• Member of International Disk Drive and Equipment Materials Association (IDEMA) Standards Committee
• Member of U.S. Technical Advisory Group to ISO Technical Committee 209 (international cleanroom standards i.e., ISO 14644 Cleanrooms and Associated Controlled Environments)
• Member of ASTM Subcommittee E55.06 Working Group “Guide for Critical Airflow Visualization”
• Board member of the Institute of Environmental Sciences and Technology (IEST) 

Morgan has been instrumental in drafting and editing international cleanroom standards, contamination control guidelines and best practices. He has extensive experience working on cleanroom projects in the United States, Canada, Mexico, Germany, South East Asia, United Kingdom, Ireland, China, Philippines, India and Turkey and is a valuable resource in addressing contamination control in critical environments for the electronics, aerospace and healthcare industries. As a key member of Microrite’s Expert Contamination Control team, he is instrumental in development of proactive contamination control strategies through pragmatic risk assessment, particle testing and airflow visualization. Morgan’s broad experience troubleshooting contamination issues has helped companies with FDA 483/warning letter remediation. 

Chapter titles and authors