Nebulizers: Package Integrity Testing Challenges And Solutions

Sterile packaging is essential for nebulizer-based pharmaceuticals, as these medications are highly susceptible to contamination. Because nebulizers deliver drugs directly to the lungs, even minor breaches in packaging integrity can introduce harmful microbes or particulates into the respiratory tract. Regulatory frameworks such as FDA guidance, USP 1207, and EU Annex 1 provide critical standards for ensuring sterility and integrity throughout the packaging process. Common formats like pre-filled nebulizer cups, transfer syringes, and blow-fill-seal (BFS) nebules present unique challenges, particularly in seam and tear-off regions prone to leaks. Advanced testing methods, such as vacuum decay, offer deterministic and quantitative leak detection, enabling manufacturers to identify and mitigate risks before products reach patients.

Explore how these solutions safeguard medication efficacy and patient safety.