Page 35 - Assurance of Sterility for Sensitive Combination Products and Materials

CHAPTER 3

Terminal sterilization

c
a
b
Vu H. Le , Scott Weiss , Brad Lundahl , Stan Lam d
a Divisional Engineering, Abbott, Temecula, CA, United States
b Industrial Microbiology, Johnson & Johnson Microbiological Quality and Sterility Assurance, Raritan, NJ,
United States
c Johnson & Johnson Microbial Quality and Sterility Assurance, Raritan, NJ, United States
d Process and Technology Development, Stryker Neurovascular, Fremont, CA, United States
Contents
3.1 The history of sterilization 23
3.1.1 History of radiation sterilization 24
3.1.2 History of EO sterilization 25
3.1.3 History of dry and moist heat sterilization 26
3.2 Sterile validation of current methods 27
3.2.1 Product qualification 28
3.2.2 Equipment qualification 28
3.2.3 Sterilization validation approaches 28
3.2.3.1 Bioburden-based approach 30
3.2.3.2 Bioburden and BI-based approach 31
3.2.3.3 BI approach 33
3.2.4 Validation overview 33
3.3 Future approaches to sterilization 34
3.4 Conclusion 36
References 37
Further reading 38

3.1 The history of sterilization
Sterilization in the early 20th century was based on the work pioneered in
the late 19th century by the likes of L. Pasteur, C. Chamberland, R. Koch,
and E. Bergmann, and usually involved high heat processes such as dry
or moist heat for medical products made of high heat-resistant materials.
Following World War II, a confluence of scientific and technological ad-
vancement in the areas of microbiology, medical products, polymer chemis-
try, and radiation physics, as well as private and public [1,2] investigation of
food preservation technologies led to the development of low-temperature
terminal sterilization technologies [radiation and ethylene oxide (EO)] in
the 1950s based on a probabilistic model of sterility [3].
Today, just over 60 years later, the most commonly used modalities of
terminal sterilization processing of medical products are radiation, EO, and
Assurance of Sterility for Sensitive Combination Products and Materials © 2020 Elsevier Inc.
https://doi.org/10.1016/B978-0-12-805082-8.00003-7 All rights reserved. 23