Statistical Sampling Plan Alternatives for Seal Strength Testing on Pre-sealed Tyvek® Bags

Abstract

Seal strength is an important quality of sterile barrier systems used for Pharmaceutical and Medical Device Packaging operations, and subject to strict quality control industry-wide. This study evaluated the feasibility of sampling plans alternatives, specific for testing of Tyvek pouches, with focus on reducing cost with minimum impact on risks. Previous studies, data analysis, and results obtained showed minimum influence by variables such as suppliers and product characteristics, providing valuable information and the frame work to support cost-effective process improvements. Key Terms - pouches, seal integrity, seal strength, sterile barrier.