QRM Process

Company Provides QbD-based Program for IVD Manufacturers

Source: Newswise

Aug 05, 2014

Multisorb’s QbD-based Calculations through Operations® program provides IVD companies with a turnkey solution for promoting the stability of moisture and oxygen sensitive products.

Certain IVD devices can be extremely sensitive to moisture, oxygen, and, in some cases volatiles. Therefore, environmental management of the packaging headspace will play a major role in ensuring that the device reagents and chemistries remain stable. Because of the negative impact these external environmental elements can have on the device stability, taking a quality by design approach in the developmental stages ensures the desired stability outcome for products.

Working in close consultation with its clients, Multisorb’s scientists use its Calculations through Operations program to calculate and develop an optimized sorbent (desiccants, moisture regulators, oxygen absorbers, and volatile adsorbers) for the specific application. This modeling can save considerable development time over the typical sorbent ranging studies.

Read the Multisorb press release