Impact of Controlled Superheated Steam Conditions on a Commercial Peel-Pouch Sterile Barrier Systems: A Pilot Study

Saturated steam remains the primary sterilization modality in healthcare facilities globally; however, superheated steam may compromise sterile barrier integrity. Limited data characterize how superheated steam affects peel-pouch sterile barriers under controlled conditions. This pilot study evaluated peel-pouch performance under saturated steam control and experimental superheated steam conditions. Seventy-two samples were exposed to four exposure scenarios using an ISO 18472:2018 compliant BIER vessel: control and experimental treatment at both 121 °C and 132 °C (N = 18 per group). Outcomes included visual inspection (cracking, discoloration, peel-off), bubble emission testing and peel strength testing. Fisher exact tests with Bonferroni correction evaluated categorical outcomes; two-way ANOVA evaluated peel force data. Visual damage showed no statistically significant difference across conditions (Fisher–Freeman–Halton exact test, p = 0.422), ranging from 5.6% in controls to 22.2% at 121 °C experimental conditions (OR = 4.85, p = 0.038). Pairwise odds ratio estimates suggested a possible increase in visible damage under experimental conditions; however, the overall comparison was not statistically significant. Bubble emission testing revealed highly significant differences (p = 0.0014), with experimental conditions showing 71.43% failure at 121 °C versus 11.11% in controls. Peel strength was dramatically reduced in experimental samples (47.4% reduction; F = 154.83, p < 0.0001), independent of temperature. Visual inspection failed to detect barrier compromises evident through functional and mechanical testing. In controlled laboratory conditions using a single peel-pouch brand, exposure to controlled superheated steam conditions was associated with significant barrier damage. These findings underscore the need for comprehensive barrier testing beyond visual inspection in sterilization validation.