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White Paper: Establish Container Closure And Leachable Controls - A Lifecycle Container Closure Database
A database coupled to a statistical analysis program is an effective means for defining a control space, determining process capability of components, establishing specifications for components and drug product and potentially correlating leachable levels to component extractable levels.
The Data are Exported to JMP or Other Statistical Analysis Neural Net Modeling is used to model data and predict/correlate process behavior.
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