MDI and DPI Drug Products
...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.....Documentation in Drug Applications for Container and Closure Systems Used for the..
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 aerosol dispenser consists primarily of a metal or glass container, a valve assembly, and an.....Interaction of the formulation with various container and closure components may contribute adversely to the..
http://www.fda.gov/cder/fdama/difconc.htm (score=37)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...In MDIs, the container and closure system consists of the container, the actuator, the valve and its components, and any additional.....The dimensional measurements of metering valve components should be held to very tight.....The design, composition, and quality control of the individual components of the container and the closure..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=32)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...In MDIs, the container and closure system consists of the container, the actuator, the valve and its components, and any additional.....The dimensional measurements of metering valve components should be held to very tight.....The design, composition, and quality control of the individual components of the container and the closure..
http://www.fda.gov/cder/guidance/2180dft.htm (score=32)

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