Toward Enhanced Machine-Based Release in X-ray Sterilization

D Prieels, C Wilson, F Kuntz, J Mittendorfer… - Biomedical …, 2024 - array.aami.org
Trends toward the use of irradiator parameter release (also called machine-based release)
put pressure on equipment manufacturers to guarantee accuracy and reliability of monitored …

Power of Parametric: Methods to Validate Ethylene Oxide Sterilization Parametric Release

E Coakley, L De Alba Nunez… - Biomedical …, 2023 - array.aami.org
When approaching an ethylene oxide (EO) sterilization validation, medical device
manufacturers traditionally have two choices. They can use biological indicators (BIs) to …

Principles of Parametric Release: Emphasis on Data Collection and Interpretation

B McEvoy, A Maksimovic, D Howell, H Michel - 2023 - array.aami.org
Parametric release, which relies on use of process data for product release, provides many
benefits. However, adoption by the sterilization industry has been slow, with release typically …

[HTML][HTML] PDA Midwest Chapter's Parametric Release Event–A Call to Action

M Sadowski - pda.org
PDA Midwest Chapter The PDA Midwest Chapter's event, Parametric Release–A Call to
Action, has been developed to raise awareness and address challenges to promote the use …