Multisorb Technologies Helps Diagnostics Manufacturers Speed Time to Market With Simulsorb and Simulox Services
Buffalo, NY - July 21, 2009
Pseudo-Empirical Modeling Services Help Achieve True Quality by Design Standards
As part of the company's proprietary Calculations through OperationsSM (CTO) Quality by Design customer support program, Multisorb Technologies, a global leader in active packaging technology, offers its value-added SimulSorbSM and SimulOxSM services for the diagnostics market.
Referred to as the Calculations component of the CTO program, the pseudo-empirical modeling services are designed to help IVD product manufacturers determine the right active packaging solution for maintaining an IVD product formulation's chemical and physical characteristics over time.
SimulSorb provides an analytical tool to pseudo-empirically predict the stability outcome of an IVD product formulation susceptible to moisture degradation under given conditions early in the development process. Similarly, SimulOx service offers an approach for the management of oxygen in IVD product packaging. The analyses help diagnostic equipment manufacturers with specifications and recommendations for the ideal product and packaging combinations for IVD product stability.
SimulSorb and SimulOx are recommended early in the development process to help manufacturers avoid costly and time consuming sorbent ranging studies, saving approximately 6-12 months of development time and ultimately effectively speeding time to market.
Additionally, these services help manufacturers achieve true Quality by Design (QbD), a systematic approach of reaching quality standards by looking at the entire developmental system and product shelf life. By providing a framework for controlled development, manufacture and commercialization of IVD products, QbD brings to the forefront some of the essential, yet often overlooked elements of quality assurance throughout the stability profile of an IVD product.
"Our value-added customer support program brings precision and predictability to the process of choosing the right type, amount, and format of active packaging technology," says Adrian Possumato, global director, healthcare packaging, Multisorb Technologies. "With our SimulSorb and SimulOx services we can help customers identify and incorporate the ideal moisture and/or oxygen management solution for ensuring the stability and quality of their IVD products."
