Multisorb Highlights Solutions at the American Association of Clinical Chemists (AACC) Clinical Lab Expo
Multisorb has been showcasing its services and solutions at the American Association of Clinical Chemists (AACC) Clinical Lab Expo in booth 2003 from July 27 – July 29, 2010 in Anaheim, CA. As in vitro diagnostic (IVD) devices become more complex and sensitive, frequently there is a corresponding need for highly specialized sorbents that are custom built and can be incorporated into the packaging of the device. Using intelligent sorbents can help ensure IVD reliability and integrity.
|Adrian Possumato, Global Director of Healthcare Packaging at Multisorb Technologies|
More than an off-the-shelf product may be needed. “The reality is, there is no such thing as a one-size-fits-all solution,” says Adrian Possumato, Global Director of Healthcare Packaging at Multisorb Technologies (Multisorb). “Each IVD device is sensitive to the threats posed by oxygen and moisture. To manage these elements, an intelligent sorbent is required, and they are specially formulated to the unique requirements of each device. They are charged with actively controlling the packaging environment so the sensitive collection areas on the device are protected and its ability to function at an optimal level is preserved.”
To determine the components of the intelligent sorbent, Multisorb uses a proprietary pseudo-empirical modeling service called Calculations through OperationsSM (CtO) relying on two core components for Calculations—SimulSorbSM and SimulOxSM.
According to Multisorb, SimulSorbSM determines the best approach to managing moisture levels in packaging by predicting the effect moisture will have on an IVD device. This is done by modeling exactly what will occur with an IVD device using various types of barrier materials and sorbents. SimulOxSM considers the effect oxygen will have on an IVD device and helps determine the unique formulation of a sorbent required to manage the oxygen environment within the device’s package. It helps to reduce the rate of, or otherwise eliminate, oxidative degradation in not only medical devices but drug substances and drug products.
The outcome of these CtO tests will not only show what the specific components of the sorbent to manage the IVD should be, but also the related packaging requirements. “Manufacturers are urged to use both analytical tools early in the development phase. This will save approximately six to 12 months of development time and ultimately speed up the time to market. It also helps avoid costly and time-consuming errors by choosing the wrong sorbent,” adds Possumato.
Multisorb reports that intelligent sorbents ultimately assume the role of an environmental manager and provide a steady-state level of protection for the IVD device. They can also be multifunctional in nature and balance specific levels of moisture and/or oxygen. Intelligent sorbents can also adsorb hydrocarbons in the packaging headspace, which could compromise the IVD device. Multisorb’s line of intelligent sorbent solution formulations is called IntelliSorbSM.
Once the unique components of the intelligent sorbent have been formulated, the most appropriate delivery system, which ensures the intelligent sorbent is placed in the IVD device’s packaging, must be selected. The type of delivery system will depend on the type of device, how it will be packaged, and the type of environmental challenges the intelligent sorbent needs to manage.
IntelliSorbSM solutions can be delivered into an IVD device in three ways, Multisorb reports:
Drop-in solutions are used primarily for single-use devices. These include home test kits for pregnancy, blood glucose monitoring, drug content in blood or urine that are discarded after one test. The drop-in solution, contained in secondary packaging, provides an integrated approach to moisture and/or oxygen management, and is delivered in either a traditional desiccant packets or canisters via Multisorb’s StabilOx or StripPax packet or canister dispensers. Both dispensers are easily integrated into the manufacturer’s production line.
The StabilOx System is a turn-key solution designed to drop IntelliSorb solutions into IVD products on the production line. The StabilOx System is made up of StabilOx oxygen and moisture management packets and StabilOx packet dispensers. StabilOx packets are designed to reduce packaging headspace oxygen levels, while managing headspace moisture and IVD device free moisture, to eliminate oxidative degradation.
The StripPax System is made up of StripPax sorbent packets and StripPax dispensers. StripPax are compact, durable, non-dusting sorbent packets designed in strip form for fast automated loading and dispensing through StripPax Dispensers.
Fit-in solutions include custom-made compressed or molded sorbents that are specifically manufactured into a particular size and shape, and fit into a device creating an onboard solution.
As a fit-in solution, standard or IntelliSorbSM intelligent sorbents can be delivered as compressed Multiform CSF (Coated Solid Form) devices accommodated in the IVD device.
Another example is Multisorb’s Multiform CSF Flip-Top Vial. The functionality of this vial is based on the Multiform CSF, a compressed silica gel, molecular sieves, and/or activated carbon sorbent products incorporated in the base of the flip-top vial. The specially configured polypropylene flip-top vial is designed to offer low moisture ingress, including vial/closure interference and resin selection.
With Multisorb’s PolySorb sorbent thermoplastic products, built-in sorbents are integrated into thermoplastic structural components of the device. This brings multifunctional capabilities to an existing device part and provides protection to IVD’s that are designed for frequent use.
“This highly complicated process shows why it is so important to have a sorbent packaging strategy that is well defined long before an IVD device enters the mass production phase,” concludes Possumato. “The strategy must be based on the IVD device, its unique and intelligent moisture, oxygen and hydrocarbon management requirements, its chemical makeup, shelf life and entire life cycle requirements from manufacture to end-use.”
The CtO pseudo-empirical modeling service helps manufacturers of IVD devices achieve true Quality by Design (QbD) standards, which saves them time and money by ensuring their products get to market quicker and remain stable and accurate.
Provided by: Multisorb Technologies