Multisorb Technologies Highlights its Calculations Through OperationsSM QbD Program to Support Its Sorbent Systems Solutions at Interphex 2009
Buffalo, NY, March 17, 2009
Multisorb Technologies, the global leader in active packaging technology, highlights its SimulSorbSM and SimulOxSM services at INTERPHEX 2009, March 17-19, Booth #431 at the Jacob K. Javits Convention Center in New York. The value-added services are part of Multisorb’s Calculations through OperationsSM customer support program designed to help manufacturers achieve QbD (Quality by Design) standards by providing for the physical and chemical stability of drug substances and products via active packaging solutions.
In addition, Multisorb will showcase its high-performance system solutions, which offer pharmaceutical manufacturers an integrated active packaging approach that incorporates Multisorb’s high speed and reliable dispensing equipment with its portfolio of intelligent sorbent packets. The system solutions are designed to deliver unparalleled reliability and efficiency to packaging operations, helping manufacturers realize time and cost savings.
SIMULSORB & SIMULOX SERVICES
Multisorb’s SimulSorbSM service provides pharmaceutical manufacturers with a critical means to achieving true QbD, a systematic approach of reaching quality standards by looking at the entire developmental system and product shelf life. QbD brings to the forefront some of the essential, yet often overlooked elements of quality assurance throughout the stability profile of a drug product. For example, maintaining the stability of a drug product formulation requires controlling the relative humidity of a pharmaceutical package’s headspace and drug product’s free moisture level over time.
This can be achieved through SimulSorbSM, wherein Multisorb pseudo-empirically predicts the stability outcome under given conditions. The analysis helps formulation chemists and packaging engineers provide specifications and recommendations for the ideal drug product and packaging combinations. It will also determine the exact amount of sorbent required to protect packaged pharmaceutical products from various pathways of chemical and physical degradation.
SimulSorbSM is recommended early in the development process to help drug product manufacturers avoid costly and time consuming sorbent ranging studies, saving 6-12 months of development time.
Multisorb’s SimulOxSM service provides a similar approach for the management of oxygen in pharmaceutical packaging. For example, maintaining the stability of a drug product formulation requires controlling the oxygen concentration is a pharmaceutical package’s headspace over time.
SYSTEM SOLUTIONS
During the show, Multisorb will also highlight its system solutions that address the needs of healthcare packaging applications. Included will be the company’s StripPax® System, a turnkey solution incorporating Multisorb’s StripPax Packets and StripPax Dispensers with dry air purge capabilities designed to extend handling time of the StripPax Packets during commercial packaging operations.
Another key offering is the Stabilox® System, which utilizes Multisorb StabilOx Packets for oxygen scavenging in low relative humidity environments, enabling manufacturers to prevent the effects of oxidative degradation in drug formulations. Similar to the dry-air purge for the StripPax Dispenser, the StabilOx Dispenser incorporates an automated nitrogen purge mechanism and associated monitoring mechanism to protect the scavengers from expending capacity before insertion.
In addition, Multisorb will highlight its APA-4000 twin-head, high speed dispenser, developed to work exclusively with Multisorb’s full range of StripPax, StabilOx, and FreshPax sorbent packets. This model dispenses sorbents at high speeds into a broad range of healthcare product packaging.
