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here for Certificate of Sterility request.
Cardinal Health, Scientific and Production Products' critical assurance
gloves are sterilized by gamma irradiation.
Products sterilized by gamma irradiation undergo standard dosimetric
release procedures. Dosimetric release is a process through which
quality assurance (QA) personnel ensure that the absorbed dose (measured
in kGy) the product receives is greater than or equal to the predetermined
minimum sterilization dose (MSD) and that the calculated maximum absorbed
dose the product receives is less than or equal to the preestablished
maximum acceptable dose (Dmax). The amount of radiation the product
receives is measured using the ceric-cerous dosimetry system.
Scientific and Production Products owns and operates the largest cobalt
facility in North America. The sterilizing units are validated periodically
in accordance with guidelines of the Association for the Advancement
of Medical Instrumentation (AAMI) to provide a sterility assurance
level (SAL) of 10-6 — a one-in-a-million chance of microbial
survival.
As a final assurance, Scientific and Production Products guarantees
the sterile integrity of products when packaging remains unopened
and undamaged.
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