Sterilization validation must be based on a robust, quality-by-design philosophy; autoclave overkill cycles should be validated by correlating lethality data to support chosen critical process ...

The author describes various manufacturing processes and evaluates whether the guidance can be applied to each of them. In November 2008, the US Food and Drug Administration issued Draft Guidance for ...

This sterilization validation process training webinar will review the FDA or ISO requirements for tests following validation and emphasis is placed on the appropriate tests for validation, the ...

The use of advanced monitoring technologies in four key aspects of EtO sterilization can yield substantial business and regulatory benefits. Paul J. Sordellini, Frank R. Bonanni, and Gregory A.

Sterilization Global Sterilization: Making the Standards Standard The new harmonized documents may hold the key to sterilization standards, but critical changes are in store for manufacturers. Robert ...

HAW RIVER, N.C.--(BUSINESS WIRE)--Andersen Sterilizers, international manufacturer of high-efficiency, flexible chamber, low temperature gas sterilizers, today announced 510(k) clearance by the U.S.

The sterilization monitoring market is becoming increasingly vital for organizations committed to ensuring safe, compliant, and efficient operations across healthcare, pharmaceuti ...

Dublin, May 28, 2025 (GLOBE NEWSWIRE) -- The "Sterilization Monitoring Market by Product Type, Sterilization Method, Monitoring Approach, End User - Global Forecast to 2030" report has been added to ...