MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....An alternative approach may be used if such approach satisfies the requirements of the.....stem orifice of the valve, the vapor pressure in the container, and the nature of the..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

...However, the ultimate responsibility for suitability of equipment used in drug processing rests.....If the change gives increased assurance of product quality, then the change can be put.....b) Microprocessors can be used for controlling a steam valve, maintaining pH, etc. They consist of a single integrated..
http://www.fda.gov/ora/inspect_ref/igs/csd.html (score=80)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...The specific valve used in each MDI drug product should be carefully selected considering the type and critical.....The type of backing used in a TDS product may vary the drug delivery rate and the adhesion of the TDS to.....Even slight changes in the formulation, drug substance particle size, valve, or actuator can have a major effect on the..
http://www.fda.gov/cder/fdama/difconc.htm (score=6)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...The specific valve used in each MDI drug product should be carefully selected considering the type and critical.....All proposed acceptance criteria should reflect the test results of valves used in submitted drug product batches.....Specific citations to food additive regulations for materials used in fabricating the valve, where applicable..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=5)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...The specific valve used in each MDI drug product should be carefully selected considering the type and critical.....All proposed acceptance criteria should reflect the test results of valves used in submitted drug product batches.....Specific citations to food additive regulations for materials used in fabricating the valve, where applicable..
http://www.fda.gov/cder/guidance/2180dft.htm (score=5)

GUIDE TO INSPECTIONS OF LYOPHILIZATION OF PARENTERALS
...In an inspection of a biopharmaceutical drug product, a Pseudomonas problem probably attributed.....Since lyophilizer sterilization and sterilization of the nitrogen system used to backfill.....When this valve is closed the chamber is isolated from the external condenser. Also known..
http://www.fda.gov/ora/inspect_ref/igs/lyophi.html (score=5)

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