MDI and DPI Drug Products
...Documentation in Drug Applications for Container and Closure Systems Used for the.....elastomeric, plastic components or coatings of the container and closure system when in.....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 actuator.....The specific valve used in each MDI drug product should be carefully selected considering the type and critical.....The design, composition, and quality control of the individual components of the container closure are key..
http://www.fda.gov/cder/fdama/difconc.htm (score=37)

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