This timely and informative text discusses aspects of
contamination control in cleanrooms seldom described in detail in the
literature. The increasing number of warning letters, product recalls and 483
observations related to both particulate and microbial contamination indicates
that contamination control principles need to be better understood from both a
practical and scientific perspective to the global regulations that controls
This text covers risk-based approaches to a cleaning and disinfection program and case studies in contamination control. It provides details on safe building techniques for new cleanrooms and modifications of existing areas by providing a risk-based approach for cleaning and disinfection using good science. It also discusses the dangers of outdated cleanroom and barrier systems designs, and that limited understanding of the real airflows has led to repeat contamination related observations worldwide. Case study examinations discuss the most common causes of contamination and many useful solutions on how to proactively prevent recurring contamination are presented.
Not mitigating contamination possibilities leads to cleanrooms and barrier systems which are unsuitable for the manufacture of sterile products and pose a risk to product and patient. This text provides the help readers need.
Table of Contents:
Click here to download >>>Detailed Table of Contents
- Contamination Related Case Studies and 483 Observations by Morgan Polen and Ziva Abraham
- Paper Compliance vs Factual Contamination Control by Ziva Abraham
- Design Basics of Pharmaceutical Cleanrooms by Wei Sun
- Cleanroom Design Quality Control and Documents Review by Wei Sun
- Cleanroom Airflow Validation in Design Phase by Wei Sun
- Air Flow Visualization: The Most Misunderstood and Underutilized Contamination Control Tool by Morgan Polen
- Static Charge: The Unseen Contaminant by Larry Levit
- Designing, Commissioning and Risk Assessing Cleanrooms for Biocontamination Control by Tim Sandle
- Cleanroom Commissioning and Qualification by Wei Sun
- Human Borne Contamination — When Cleanroom Reusable or Disposable Garments Cannot be a Good Barrier by Jan Eudy
- Viable and Non-Viable Airborne Particle Monitoring Equipment Selection by Bill Shade
- Foot and Wheel Borne Contamination by Krishna Bell and Ziva Abraham
- Validation of Disinfectants by Tim Sandle, Laura Guardi, Rachel Kirkham and Kim Morwood
- Case Studies for Improving a Risk-Based Cleaning and Disinfection Program by Jim Polarine and Beth Kroeger
- Cleanroom Cleaning — Choosing, Using, and Handling Cleaning Material by Matts Ramstorp
About the Editors
Ziva Abraham has over 35 years of academic, research, clinical and industrial experience in Microbiology, and Quality Assurance. Ziva has received her masterâ€™s degree in Microbiology and has conducted research on developing Microbial Insecticides using entomogenous bacteria and fungi towards her Ph.D. degree.
She worked as a clinical scientist for many years 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 many rapid testing methods into the group of laboratories she helped establish and manage for Maccabi Medical. These laboratories 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 on patients. Ziva is passionate about fungi; as in her research she had collected, identified, and tested hundreds of species. She routinely teaches hands-on fungal identification as well as investigation
and remediation of mold contamination and most importantly the emergence of new fungal infections.
Ziva established Microrite, a California based consulting firm, in 1998 as an independent microbiology consultant. Ziva 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. Zivaâ€™s team works congruently to resolve client issues, prevent contamination through design and help clients produce 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. Morgan has over 35 Years of industry experience working in cleanrooms in all industries.
Morgan's Technical Leadership:
- 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, Malaysia, Taiwan, South Korea, Singapore, Thailand, 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, Morgan is instrumental in development of proactive contamination control strategies through pragmatic risk assessment, particle testing and airflow visualization. Morganâ€™s broad experience troubleshooting contamination issues has helped companies with FDA 483/warning letter remediation.