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CHAPTER 7
Risk to the patient—Quantifying
assurance of sterility
a
a
b
Marc L. Speck , Harry Frederick Bushar , James Niederecker ,
Byron J. Lambert c
a R&D Quality, Abbott Vascular, Temecula, CA, United States
b Retired Statistician, Rockville, MD, United States
c Assurance of Sterility Task Force, ASTF, Abbott, Temecula, CA, United States
Contents
7.1 Risk concepts applied to sterility assurance 167
7.2 Statistical concepts applied to sterility assurance 169
7.2.1 Point estimates 170
7.2.2 Confidence interval example 171
7.2.3 Confidence bounds 175
7.2.4 Statistical analysis types 176
7.3 Statistical analysis of risk associated with packaging and sterilization 179
7.3.1 Introduction to scenarios analyzed 179
7.3.2 Point estimates and confidence bounds—Packaging 179
7.3.3 Point estimates and confidence bounds—Aseptic processing 182
7.3.4 Point estimates and confidence bounds—Terminal sterilization;
bioburden-based approach 186
7.3.5 Point estimates and confidence bounds—Terminal sterilization;
overkill method 191
7.3.6 Summary of statistical analysis 194
7.4 Relative patient risks from various industry sectors compared to
real-world infection rates 196
7.4.1 Estimates of infection probabilities 196
7.4.2 Other factors influencing the assurance of sterility 202
7.4.3 Comparison to real-world infection rates 204
7.5 Risk acceptability—Bringing it all together, the real risk to the patients 205
7.6 Conclusion 207
References 208
This chapter provides a novel look at patient risk by quantifying certain
aspects of assurance of sterility related to packaging, aseptic processing,
a
terminal sterilization, and product use at health-care facilities. Terminal
sterilization (Chapter 3) with a validated logarithmic reduction in product
a
Note: reprocessed devices are not included in the analysis of this chapter.
Assurance of Sterility for Sensitive Combination Products and Materials © 2020 Elsevier Inc.
https://doi.org/10.1016/B978-0-12-805082-8.00007-4 All rights reserved. 165