Multisorb Technologies Introduces Its Calculations Through Operations Program for the Diagnostics Market at AACC 2009
Buffalo, NY - June 12, 2009
Program Helps Manufacturers Achieve True Quality by Design (QbD) and Speed Time to Market
Multisorb Technologies, the global leader in active packaging technology, will introduce its proprietary Calculations through OperationsSM customer support program for the diagnostics market at the 2009 AACC/CSCC Annual Meeting and Clinical Lab Expo, July 19-23, Chicago, IL, Booth #256.
The program combines Multisorb’s value-added pseudo-empirical modeling programs, including SimulSorbSM and SimulOxSM services and the company’s portfolio of high-performance sorbents. Together, the main components of the program provide manufacturers with the tools to identify and incorporate the right sorbent solution early in the product development and manufacturing cycle, helping them achieve true Quality by Design (QbD) standards and speed time to market.
Program components include:
- Calculations refer to the use of Multisorb’s SimulSorb and SimulOx pseudo-empirical modeling services. It involves integrated mathematical modeling using empirically-derived measurements of the specific IVD product formulation, packaging, and our intelligent sorbents. This process is critical in helping companies determine the right sorbent solution for their products.
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.
- Operations imply the use of Multisorb’s sorbents with its industry-standard dispensing machinery for a turn-key implementation at the clinical and commercial packaging operations level. The company’s sorbents provide protection to diagnostic products by controlling the level of moisture, oxygen, and/or hydrocarbons within the product packaging. They are incorporated into the packaging using Multisorb’s high-speed dispensing equipment.
The two components of the program come together to effectively provide turn-key, downstream operations solutions as established with the upstream, R&D calculations.
“We aim to help our customers move to the next level of process efficiency and quality assurance by achieving QbD with our Calculations through Operations program,” says Adrian Possumato, global director, healthcare packaging, Multisorb Technologies.
QbD is a systematic approach of reaching quality standards by looking at the entire develop-mental system and product life cycle. It brings to the forefront some of the essential, yet often overlooked elements of quality assurance assessment of a IVD product. For example, maintaining the stability of a drug formulation requires controlling the relative humidity and/or oxygen concentration of the headspace of the device packaging and the free moisture level of a drug product over time. But this critical step in the process is seldom taken into account until a problem arises late in the development or even approval process. QbD helps manufacturers avoid such problems by providing a framework for controlled development, manufacture and commercialization of products.
Multisorb executives will be available at the booth to discuss the company’s new program, its products and full range of value-added services.
Multisorb Presentation: Flip-top vials with integrated desiccant ensure product stability and effectiveness
Multisorb’s Adrian Possumato will also take part in AACC’s extensive OEM Lecture Series. He will deliver an informational presentation discussing the evolution of flip-top desiccant vials on July 21st at 10:20am. Possumato will take a comparative approach and present information on the past, present and future of flip-top desiccant vials and the benefits they deliver to the diagnostics market.
