Page 265 - Assurance of Sterility for Sensitive Combination Products and Materials

Path forward 243

Patients do not benefit from an R&D solution, however. They bene-
fit when that solution is implemented to bring them an innovative sterile
product. The sterility assurance professional needs to source the solution
and then develop a robustly validated process. (S)he also needs to implement
a robust supply chain with contingency since sterilization is a single point
of supply chain failure. In addition, the SA (sterility assurance) professional
needs to understand the process and the business deeply in order to appro-
priately address process and product exceptions that challenge the supply
chain.
Coupled with all of this is the reality that all sterile products require ro-
bust sterile barrier systems to maintain sterility over time. Interfacing with
the design of robust and sterilization compatible packaging for the shelf life
of the product is critical (see Chapter 5).

10.4.2 Bringing it all together in a risk management
framework
Bringing innovative product to market with robust sterility assurance will
never be easy. The sterility assurance professional needs to pull all the above
factors into a deep understanding of the product development process and
risk management (see Chapter 8). As highlighted in Chapter 7, a simplistic
approach will not be sufficient. All the inputs and risks need to be assessed
in a risk-based framework that allows patient needs to be prioritized. This
requires well-rounded, experienced, and collaborative sterility assurance
professionals to seize the opportunities being provided for the patient. This
is being made possible with increasing pan-industry forums provided in the
industry. For example, Johnson and Johnson resurrected the Kilmer confer-
ence in 2016 to bring together thought leaders from the regulatory agen-
cies, industry, and academia. In addition, they donated the proceedings of
the Kilmer conference from 1974 to 2003 to AAMI to provide resources to
the sterilization community [8].

10.5 What is next for the patient?

Confidence in a flow of valuable and innovative products facilitated by
sterility assurance professionals minimizing the risk of infection is the key.
Advances in biologics, personalized medicine, and new sensitive combina-
tion products will open new products and treatments to patients. A thorough
understanding of the balance of risks to benefits and the options available
to the sterility assurance professional is necessary. Nothing else will suffice!