Page 8 - Assurance of Sterility for Sensitive Combination Products and Materials

xii Foreword

and therapies will require new approaches to product development and
process control. This is happening in a time of expanded global distribution
and manufacturing, requiring a more diversified level of regulatory aware-
ness, understanding, and compliance strategies.
There are challenges ahead for those developing and manufacturing
sterile combination products. Are we prepared for such innovation and
change? Is our industry, including those who regulate it, equipped to de-
velop, manufacture, test, distribute and control the quality of these new
products efficiently and effectively to best serve our patients?
This book has been written to help the reader recognize, understand,
and meet these challenges, from the development, manufacture, test, and
control the constantly improving innovative combination products. It pres-
ents the background and the requirements for the rapidly emerging field
of sensitive combination products through an overview of the history, defi-
nition, and classification strategies used by regulatory bodies, and an ex-
ploration of traditional and novel sterilization methods instrumental for
successful combination products.
To better understand where we must go, we must start by defining our
destination: the sterility and sterility assurance of sensitive combination
products. The use of sterility assurance terms across the health-care sectors,
including sterility assurance level and probability of a non-sterile unit must
be fully understood to understand the true risk to the patient. To that end,
chapters of the book explore the current and emerging disciplines use to
produce products to achieve and maintain sterility assurance. This includes
sterilization, aseptic processing, packaging, and a thorough discussion and
exploration of the development, validation and routine control of contam-
ination, and process control of health-care products.
The role of bioburden control and process validation throughout the
design and defense of the contamination control strategy are explained. It
starts with the identification of product quality attributes and related re-
quirements, then leads to the development of process steps to attain, validate,
maintain, and monitor those product quality attributes, through the critical
process parameter including the sterilization of product and the prevention
of contamination.
Chapters of the book provide the history of radiation sterilization, eth-
ylene oxide sterilization, and heat sterilization, an overview of the prin-
ciples and methods for validating the logarithmic reduction in microbial
load by a terminal sterilization process, traditional overkill approach, and