Automated verification system

The Antigermix has a sophisticated quality assurance system that uses three optical sensors (photodiodes) to measure the concentrated UV-C high level disinfection.  Two photodiodes operate the cycle and the third checks the accuracy of the measurements, providing assurance comparable to Parametric Release.

Parametric Release

ANSI/AAMI/ISO 11135 defines parametric release as the declaration that product is sterile, based on records demonstrating that the process parameters were delivered within specified tolerances.

Parametric release allows product to be released to the market based on process records instead of the traditional biological indicator sterility test, eliminating the routine costs associated with biological indicators and laboratory testing.

Meeting the requirements of the parametric release process provides greater assurance that a batch meets the sterility requirement than can be achieved with a sterility test of finished units drawn from the batch.  It also offers time, cost and resource efficiencies, with no requirement to perform sterility tests, no waiting for results and no delays attributed to investigating false positive results.