...Container and Closure System Nasal aerosols usually consist of the formulation, container, valve, actuator, dust.....Similarly, nasal sprays usually consist of the formulation, container, pump, actuator, protection cap.....If this is infeasible, we recommend that valve, pump, and actuator designs be as close as..
http://www.fda.gov/cder/guidance/5383DFT.doc (score=100)

BA/BE studies for Nasal Aerosols and Nasal Sprays for Local Ac
...Nasal aerosols consist of the formulation, container, valve, actuator, dust cap.....Similarly, nasal sprays consist of the formulation, container, pump, actuator, protection.....components and composition, metering valve, and actuator as the large container size that..
http://www.fda.gov/cder/guidance/2070dft.pdf (score=99)

MDI and DPI Drug Products
...container and closure system as a result of direct contact with the formulation of the MDI.....drug substance, optimized formulation, valve and actuator design, 89.. manufacturing process and in.....Documentation in Drug Applications for Container and Closure Systems Used for the..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=72)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...MDI products are unique with respect to formulation, container, closure, manufacturing, in-process.....The aerosol dispenser consists primarily of a metal or glass container, a valve assembly, and an.....Even slight changes in the formulation, drug substance particle size, valve, or actuator can have a major effect on the aerosol..
http://www.fda.gov/cder/fdama/difconc.htm (score=68)

Acidified food manufacturers
...Are container examinations made as per the container manufacturer specifications and or.....Formulation control would have to include consideration of such things as raw material pH.....c) Is the pressure reducer valve set properly to supply correct pressure and steam flow to..
http://www.fda.gov/ora/inspect_ref/igs/acidfgde.htm (score=21)

Packaging
...Complete construction, composition, and description of all component parts of valve closure and container.....The identity of the source and a description of the formulation(s), process(es), and.....When drugs are administered by means of an aerosol dosage form, the valve closure system..
http://www.fda.gov/cder/guidance/package.htm (score=20)

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