Page 264 - Assurance of Sterility for Sensitive Combination Products and Materials

242 Assurance of sterility for sensitive combination products and materials

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When terminal sterilization at a sterility assurance level of 10 is not pos-
sible, the well-traveled option that has also served the industry well for decades
is aseptic processing (Chapter 4). When validated and controlled appropriately,
aseptic processing maintains the sterility of sterile components and produces
sterile finished goods within sterile barrier systems/container closure systems
that do not allow further contamination. Innovation in this industry segment
is providing technologies and environments in which it is increasingly simple
and robust to combine sterile components into sterile products.
In addition to aseptic processing for product that cannot be terminally
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sterilized at an SAL of 10 , the less well-traveled option is the use of al-
ternative SALs. As discussed in Chapter 9, this option was recently framed
within ISO [7] and has been available longer through Association for the
Advancement of Medical Instrumentation (AAMI). The increased clar-
ity in this option of providing reliable and acceptable sterility assurance
for needed products should well serve the industry as well as the patients.
Chapter 7 enhances this clarity by providing a unique and broad perspective
on how validation sample sizes for packaging, aseptic processing, and ter-
minal sterilization fit into, but are not the whole story, for assuring sterility.

10.4 What is next for sterility assurance professionals?

The final area of sterility assurance focus to support innovation in meeting
patient needs is highly competent sterility assurance professionals. Within
health-care facilities, professionals experience enormous challenges under
the pressure of immediate care for patients. This requires great competence
and is likely the most important point of focus for patients from an infection
risk mitigation perspective.

10.4.1 End-to-end sterility assurance
Sterility assurance professionals in industry providing single-use products
are well served by a broad understanding of all industry segments. This can
be understood in a framework of the entire product life cycle or ‘end-to-
end sterility assurance.’ In the product R&D planning phase, knowing the
innovation within established terminal sterilization technologies as well as
innovation in novel sterilization technologies optimizes the opportunity
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to find a sterility assurance solution with a sterility assurance level of 10 .
When this is not possible, knowing the innovation within aseptic processing
and the clarified alternative SAL approach optimizes the chance of deliver-
ing valuable new products to meet patient needs.