Application Note

Integrity Testing Of Inhaler Products

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The growing reliance on inhalers for managing conditions like asthma, COPD, and post-COVID respiratory issues underscores the critical need for uncompromised product integrity. These devices deliver precise doses of medication, making sterility and stability essential to patient safety. Regulatory bodies such as the FDA now require robust container closure integrity (CCI) testing to prevent contamination and ensure efficacy. Vacuum decay testing, performed under ASTM F2338 standards, offers a deterministic, quantitative approach to detect leaks as small as 5 microns. Adaptable to both rigid and flexible packaging, this non-destructive method uses sensitive pressure measurements to confirm seal integrity throughout production.

Explore proven strategies for inhaler integrity testing and learn how vacuum decay ensures quality and safety.

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