Page 231 - Assurance of Sterility for Sensitive Combination Products and Materials

210 Assurance of sterility for sensitive combination products and materials

The development of a sterilization process impacts both product safety
and cost. It is essential to develop a robust sterilization process that ensures
a continuous supply of the product in the market.
Validation of sterilization methods using established methods [1], such
as dry heat, moist heat, ethylene oxide, and radiation sterilization, has been
extensively applied in the medical device industry and is covered in detail
in Chapter 3 of this book. This chapter focuses on the thought process for
developing the sterilization strategy for challenging sensitive combination
products. The assessment of the viability of a product concept should be
done early. The amount spent during the development of a product can
easily run into seven figures per quarter. Failing late has a major impact on
large companies and may jeopardize smaller organizations.

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8.2 Sterilize at 10 SAL
The sterilization strategy should be prioritized early in the program. This
enables the product design to be modified or the sterilization modality
be changed early on while minimizing the impact on the overall time-
lines. The avoidable wasted time, people, and capital resource would be
indefensible if the project is terminated with a fully functioning device
that cannot be sterilized. The strategy allows the team to identify addi-
tional resource and time requirements to develop a robust sterilization
process.
Products that are similar to existing products or line extensions are rel-
atively straightforward to leverage the existing sterilization methodology.
With the experience of the organization, the process can be developed
quickly and efficiently. The overall risk is low because of the experience
in developing sterilization processes for the product as well as the abil-
ity to leverage the existing infrastructure around quality, supply chain, and
operations.
Products that are new to the organization but similar to other products
in the marketplace have a medium overall risk. Although the technical risk
is low, the execution risk is high. Substantial work is required to identify
suppliers, establish the quality infrastructure, develop and document proce-
dures and processes, train employees, and work out the logistics required to
implement a new sterilization modality.
The highest risk products are both novel and have little or no precedent
within the organization. This class of products has high resource and time-
line risk. De-risking the program as soon as possible increases the probability