MDI and DPI Drug Products
...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.....drug substance, optimized formulation, valve and actuator design, 89.. manufacturing..
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 performance of the valve and its compatibility with other components of the drug.....The aerosol dispenser consists primarily of a metal or glass container, a valve assembly..
http://www.fda.gov/cder/fdama/difconc.htm (score=99)

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