Page 11 - Assurance of Sterility for Sensitive Combination Products and Materials

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CHAPTER 1

Introduction: Sterilization or

aseptic processing of single use

combination products

a
Joyce M. Hansen , Trabue D. Bryans b
a J&J Sterility Assurance, Johnson & Johnson, Raritan, NJ, United States
b BryKor, LLC, Marietta, GA, United States

Contents
1.1 Introduction 1
1.2 Sterility assurance terminology 2

1.1 Introduction

New patient treatment options continue to drive the need for the develop-
ment of combination products. Sterility assurance innovation is critical to
bring these combination products to market. This innovation requires ste-
rility assurance professionals to collaborate across the broad spectrum of the
demands of the healthcare industry. Not only does a successful sterility as-
surance professional need to be an expert in their field, but also they need to
be aware of the broad challenges and opportunities associated with bringing
a combination product to the market. This book provides an overview as
well as introduces exciting new opportunities in each industry sector. The
sectors addressed include combination products and their design, terminal
sterilization, aseptic processing, packaging, healthcare practices as well as the
worldwide regulatory environment. The topics associated with each sector
are introduced with the perspective of facilitating the development of inno-
vative new combination products.
Combination products emerged in the 1990s to reduce the potential
for infection and the time healthcare providers needed to treat patients.
Original combination products typically consisted of a means of connecting
multiple products to reduce the manipulations required. Over the last few
decades, combination products have evolved to consist of a combination of
medical devices, biologics, pharmaceuticals, and electronics to support the
next level of patient care.

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