ASAPprime® packaging
ASAPprime® Packaging Selection Without Screening
ASAPprime® enables determination of packaging without the need for package screening studies.
ASAPprime® calculates the RH as a function of time inside a package using the balance of moisture transfer rates (controlled by packaging permeability) and the ability of the product to hold moisture as a function of RH (controlled by the product’s moisture sorption isotherm).
ASAPprime® uses an extensive database of both packaging material moisture permeabilities (bottles, blisters and drums) and moisture sorption isotherms of most pharmaceutical materials that allow calculation of formulation isotherms. These determine a product, package and storage condition-specific moisture versus time behavior.
ASAPprime® combines the RH as a function of time with the calculated moisture sensitivity of the product to determine the impact of packaging on the product shelf-life. This is expressed as a percent probability of passing.
Companies have successfully used ASAPprime® as part of cost modeling, where they balance product volumes, global distribution versus zone-specific packaging and shelf-life in different zones. This ultimately allows companies to effectively model many potential scenarios without additional testing to make decisions about packaging quality and cost.
