Page 92 - Assurance of Sterility for Sensitive Combination Products and Materials

CHAPTER 5

Package/container closures

a
b
c
Thierry Wagner , Jennifer Van Mullekom , Jane Severin ,
Michael H. Scholla d
a Dupont, Luxembourg
b Virginia Tech, Blacksburg, VA, United States
c Network Partners, Warsaw, IN, United States
d Dupont, Wilmington, DE, United States
Contents
5.1 History of sterile packaging 80
5.2 Technologies 82
5.2.1 Introduction 82
5.2.2 Packaging functions 83
5.2.3 Differences between requirements of medical device and pharmaceutical
packaging 83
5.2.4 Container types/definitions/dosage form 88
5.2.5 Considerations for plastic selection-pharmaceutical and medical device
packaging 91
5.2.6 Stability issues related to packaging 93
5.2.7 Challenges for packaging combination products 94
5.3 Validation principles 95
5.3.1 Validation and patient safety 95
5.3.2 Package integrity and the limitations of sterility testing 96
5.3.3 Test methods 96
5.3.4 Design validation 102
5.3.5 Forming, sealing (closure) and assembly process validation 107
5.3.6 Packaging and device families 109
5.3.7 Managing changes and revalidation 110
5.3.8 Examples of validation approaches 111
5.4 Power and sample size considerations for medical and pharmaceutical device
packaging 115
5.4.1 A conceptual overview of power and sample size 115
5.4.2 A power and sample size example for packaging 117
5.4.3 Power and sample calculations in practice for significance testing 119
5.4.4 An overview of equivalence testing 121
5.4.5 Power and sample size considerations for equivalence testing 121
5.4.6 Sample size for process capability in process validation 122
5.4.7 Concluding remarks for power and sample size 124
5.5 New developments 124
References 128

Assurance of Sterility for Sensitive Combination Products and Materials © 2020 Elsevier Inc.
https://doi.org/10.1016/B978-0-12-805082-8.00005-0 All rights reserved. 79