Quality

Packaging Failures: A Major Cause of Sterility Recalls

Packaging design has to match product complexity.

Sterility recalls are a serious issue in the healthcare industry, and packaging failures are their largest source. Packaging design must match product complexity.

Healthcare products are becoming more complex. They include combination products, kits, larger products assembled from connected components, and products such as skin tissue.

As product complexity increases, packaging and sterilisation professionals must consider more complex material structures and recognise that materials and products may be more sensitive to sterilisation.

Sterility-assurance and packaging professionals must work together to ensure that testing results in a safe and effective package.