Method and apparatus to stress test medicament inhalation...

Details Method and apparatus to stress test medicament inhalation... Method and apparatus to stress test medicament inhalation...

2006-08-22

2006-08-22

Garber, Charles (Department: 2856)

Measuring and testing

With fluid pressure

Leakage

C374S004000

Reexamination Certificate

active

07093480

ABSTRACT:
A method and apparatus for heat stress testing medicament aerosol inhalation devices, such as a metered dose inhaler, is described. An electrical induction work coil is used to heat the inhalers to 55° C.±5° C. Heated inhalers are subsequently weighed to detect and reject nonconforming inhalers where a nonconforming amount of propellant has leaked.

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Guidance for Industry, Contain Closure Systems for Packaging Human Drugs and Biologics, Chemistry, Manufacturing, and Controls Documentation, U.S. Department of Health and Human Services Food and Drug Administrations, CDER, CBER, May 31, 1999, pp. 18-19.

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