WHY CONDUCT A D-VALUE STUDY?
To design an OPTIMAL and appropriate lethality cycle with justification and
documentation using an empirically derived D-value for a specific pharmaceutical
product.
WHEN?
New injectable products/medical devices/media or Re-Validation of an existing
product. A product-based D-value gives a resistance value that depends exclusively
on the interaction of the most resistant spores and that product.
HOW?
The product is sent to Mesa Labs, USA in a sealed container. A typical process flow
for a D-value study is as follows:
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