A peer-reviewed article, “Insights for the use of Enzyme Indicators in Hydrogen Peroxide Bio-Decontamination Cycle Validation”, has been published in the PDA Journal of Pharmaceutical Science and Technology. It draws together compiled data and methods from validation teams at leading global pharmaceutical companies, and sets out a structured approach to handling, using and analysing enzyme indicator (EI) data across the steps of bio-decontamination validation.
This is a peer-reviewed, industry-written publication. It provides a credible published reference point for using enzyme indicators within the bio-decontamination validation lifecycle.
For QA, validation and sterility assurance teams, the value is straightforward. Until now, the case for enzyme indicators has needed a stronger published reference. This article puts a substantial, multi-company dataset into the peer-reviewed literature and shows the approach applies across a wide range of enclosures and H₂O₂ systems.
It gives teams already using EIs a published foundation for the approach. For teams still considering it, it provides the scale of evidence that makes a serious internal conversation possible.
of EI results aligned with, or posed an equal or harsher challenge than, the BI result
data points
enclosures (1.5–15+ m³)
H2O2 generator systems
Biological indicators give a pass or fail. An enzyme indicator returns a quantitative result in relative light units, so teams can see how far a cycle sits above or below the level they need.
EI use is mapped from design and factory acceptance testing, through site acceptance testing, cycle development and performance qualification, into monitoring and requalification.
When a cycle behaves unexpectedly, or a biological indicator returns a rogue result, quantitative EI data adds context that a binary result cannot supply quickly.
An EI result at or below 1.00×10⁶ RLU was associated with 98% or greater confidence of achieving at least a 6-log biological reduction.
The authors describe this as the Assurance Line, a performance confidence tool to support decision-making. It is not an acceptance criterion or a predictive threshold.
The study was authored by validation specialists at Baxter Healthcare, Sanofi, AstraZeneca, Roche/Genentech and Novo Nordisk. Protak Scientific provided technical support, and the authors disclose that the paper was written in conjunction with Protak Scientific, the manufacturer of the enzyme indicator technology.
The full article is published in the PDA Journal of Pharmaceutical Science and Technology and is available via its DOI.
A peer-reviewed, multi-company dataset and a structured approach to handling, using and analysing enzyme indicator data across the steps of H₂O₂ bio-decontamination validation.
It is a performance confidence reference described in the paper. An EI result at or below 1.00×10⁶ RLU was associated with 98% or greater confidence of achieving at least a 6-log reduction. It supports decision-making and is not an acceptance criterion.
The full article is available via its DOI in the PDA Journal of Pharmaceutical Science and Technology.
Read about the advantages and benefits of using our Enzyme Indicators for your H₂O₂ bio-decontamination validation processes.
Biological Indicators vs Enzyme Indicators at a glance.
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