Page 230 - Assurance of Sterility for Sensitive Combination Products and Materials

CHAPTER 8

Developing new products

Stan Lam
Process and Technology Development, Stryker Neurovascular, Fremont, CA, United States

Contents
8.1 Background 209
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8.2 Sterilize at 10 SAL 210
8.3 Aseptic processing 212
8.4 Alternative SAL 215
8.4.1 Improving device compatibility 215
8.4.2 Reducing exposure time 217
8.4.3 Reducing bioburden 217
8.4.4 Other SAL options 218
8.5 Conclusion 218
References 219

8.1 Background

The development of single use combination devices is driven by user needs.
Research and development teams identify opportunities such as controlled
drug delivery, biodegradability, or electronic data acquisition to improve
patient outcomes, treat new conditions, or increase patient compliance. For
implantable devices, sterility is assumed and is the minimum barrier to en-
try. This hurdle is cleared while attempting to address patients’ unmet needs.
This will typically be captured in the design control process when defining
the user needs requirements. During the development cycle, the develop-
ment team generates a general sterilization strategy and constantly assesses if
the product functionality is adversely impacted by the sterilization process.
As the product design evolves, generating more data demonstrating that
product performance is maintained after sterilization, confidence that the
product is compatible with the sterilization modality will also increase. As
the product takes form, challenge sterilization conditions should also be
assessed.

Assurance of Sterility for Sensitive Combination Products and Materials © 2020 Elsevier Inc.
https://doi.org/10.1016/B978-0-12-805082-8.00008-6 All rights reserved. 209