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 (QbD) approach in the developmental stages ensures the desired stability outcome for your product.
Multisorb’s QbD-based Calculations through Operations® program provides IVD companies with an unparalleled turnkey solution for promoting the stability of moisture and oxygen sensitive 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.
Multisorb’s sorbent solutions are available in many formats including Drop-In (packets and canisters), Fit-In (compressed solid forms that fit securely into an existing space in the packaging), and Built-In (thermoformed device components with sorbent incorporated into the material). Understanding the customer’s needs allows for the optimized format to be identified and selected. PolySorb desiccant cards, offer a Fit-In solution in applications where space is at a premium. The extremely low profile of this product allows for effective moisture management with minimal impact on product packaging.
When required, the program also manages placement of a Drop-In sorbent during packaging operations with the use of a sorbent specific dispenser. The Calculations through Operations program provides the most effective and efficient solution for ensuring chemical and physical stability for IVD devices through their desired shelf life. This improved efficiency leads to time saved, faster time to market, all of which ultimately translates to money saved – and earned.
To learn more about Multisorb’s suite of sorbent products, visit us at AACC, booth 4436.