Biological indicators (BIs) strategy to use in VHP/vH₂O₂ Bio-decontamination cycle development, performance qualification and ongoing re-qualification.

Biological indicators of Geobacillus stearothermophilus spores, inoculated on stainless steel carriers within Tyvek® primary packaging are used as a challenge of efficacy for a bio-decontamination cycle during cycle development, performance qualification and subsequent re-qualification, typically to verify a VHP/vH₂O₂ bio-decontamination cycle meets 6log sporicidal requirements. Bio-decontamination cycles are a required process to establish Grade A conditions inside barrier technology and further support maintaining conditions as a contamination control measure during material transfers between GMP grades including into Grade A and within surrounding Cleanrooms.