MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....recommended for inclusion in the application regarding the components, manufacturing.....may have an effect on the quality and purity of valve components and, ultimately, 983..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...In MDI products, the container closure system consists of the container, the valve and its components.....The specific valve used in each MDI drug product should be carefully selected considering the type and critical.....For plastic components, there is the potential for drug adsorption into the plastic, swelling of the plastic, and leaching of..
http://www.fda.gov/cder/fdama/difconc.htm (score=36)

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