Page 262 - Assurance of Sterility for Sensitive Combination Products and Materials

240 Assurance of sterility for sensitive combination products and materials

10.2 Sterility assurance landscape in the 2020s
Sterility assurance has many challenges; ongoing and new solutions are re-
quired for
• high volume sterile commodity products that keep health-care facilities
meeting the needs of patients worldwide;
• now common combination products such as Drug Eluting Stents (DES)
and prefilled syringes;
• innovative and complex combination products with development
time scales of 5–15 years that do not have simple sterility assurance
solutions; and
• all forms of personalized regenerative biologics and cell therapy prod-
ucts that may require transformative approaches to sterility assurance.
This picture is complicated by current and future realities of the termi-
nal sterilization technology landscape. Moist heat, radiation, and ethylene
oxide sterilization have been the workhorses of the industry for decades,
with the latter two dominating the market for heat-sensitive health-care
products. Both radiation and ethylene oxide technologies are experienc-
ing market pressure; 80% of the radiation sterilization market uses gamma
radiation sterilization utilizing the isotope cobalt 60. There continues to
be manufacturing, transportation, disposal, and terror threats related to this
technology. Electron beam and x-ray radiation sterilization are alternative
technologies but often include cost concerns, especially with commodity
products [2]. Ethylene oxide sterilization is increasingly under pressure from
environmental health and safety perspectives [3]. Although alternative gas
technologies are available, they are still in the early stages of the develop-
ment to meet supply chain needs.
Innovation and new sterility assurance paradigms are required on
many fronts. Required sterility assurance focus areas include new steril-
ity assurance technologies (Chapters 3 and 4), a pan-industry risk frame-
work (Section 10.3), and highly competent sterility assurance professionals
(Section 10.4).

10.3 Pan-industry sterility assurance risk framework

To meet the needs of patients for innovative new products, sterility assur-
ance professionals need to see beyond the boundaries of their industry seg-
ment. The first step toward this broader patient-focused sterility assurance
approach is seeing what the patient cares about: receiving valuable new
products in a timely manner while reducing the risk of infection.