In collaboration with Protak Scientific, we recently hosted a technical webinar on VPHP cycle development and validation, bringing together more than 350 registrants and 180 live attendees. This level of engagement reflects a sustained and growing interest in advancing biodecontamination practices. In addition to the lecture content, the session included three audience polls and a traditional question-and-answer period, providing a useful dataset for evaluating current perceptions of enzyme indicators as well as the practical challenges influencing VPHP validation strategies.
The first audience poll examined the extent to which enzyme indicators are currently used. Twenty-six (26) percent of respondents reported routine or occasional use, while sixty (60) percent indicated they are not yet using enzyme indicators but are actively considering them. Fourteen (14) percent noted they were unfamiliar with the technology, which is likely why they joined the webinar to learn more. Together, these results suggest increasing adoption supported by scientific curiosity, a growing level of awareness, and overall evaluation across the sector.
The second poll focused on challenges associated with VPHP cycle validation. BI supply chain limitations and process variability were cited most frequently, each receiving thirty-five (35) responses. Investigation timelines and regulatory uncertainty followed closely in second. These insights point to a VPHP validation environment affected by both operational constraints and complexity within the regulatory landscape. It is logical that one or more of these factors may contribute to greater interest in a complementary or alternative analytical approaches to VPHP cycle development and performance.
The third and final poll focused on the factors that would improve confidence in adopting enzyme indicators. Regulatory guidance emerged as the most influential driver (unsurprisingly), followed by the availability of internal correlation data with BIs, broader access to published case studies, and general assurances around operational simplicity. In the pharmaceutical sector, we tend to appreciate a clear roadmap when evaluating new technologies, and as highlighted during the lecture, several companies have already implemented EIs successfully. This distribution of factors aligns with broader industry expectations for adopting new systems or methods (for example, isolators or rapid microbiological testing) where technologies tend to gain acceptance, as regulatory positions become clearer and as organizations generate internal evidence supporting their use.
Moving onto the Q&A session, the questions submitted during the webinar reinforced these same themes too. Several questions addressed regulatory perspectives, specifically how MHRA and the US FDA view the use of enzyme indicators alongside traditional biological indicators. Current experience from published studies and publicly available presentations indicates that enzyme indicators can be confidently incorporated into a scientifically justified, hybrid validation approach. They have been applied successfully in pharmaceutical manufacturing facilities in both Europe and the United States, as well as in a hospital setting in the United Kingdom, including the validation of eight aseptic compounding isolators.
Another area of interest involved the potential reduction or removal of biological indicators altogether following sufficient correlation to enzyme indicators and robust trending data. Attendees asked about pathways for equivalency demonstrations, expectations for continued process verification, and conditions under which biological indicators might be reserved only for initial qualification or periodic confirmation. These questions reflect organizational interest in modernizing VPHP validation workflows while simultaneously retaining alignment with current regulatory requirements, including those outlined in EU Annex 1. As the lecturer, I am encouraged by these perspectives and the willingness of industry scientists and engineers to thoughtfully challenge and advance established approaches.
Operational applicability was the final major topic for review. Questions addressed the use of enzyme indicators in proprietary VPHP generators, standalone systems, VPHP sterilizers, and atomized or misted H₂O₂ technologies for cleanrooms. The data are clear that enzyme indicators are generally compatible with gaseous hydrogen peroxide delivery methods, supporting their use across diverse equipment platforms. This flexibility is particularly exciting and relevant given the many scenarios in which VPHP is now integrated into material transfer workflows, barrier system configurations on aseptic filling lines, and other applications described in the webinar.
Taken collectively, the polling data and audience questions indicate an industry that is increasingly evaluating enzyme indicators within a structured and scientifically established validation context. Interest appears to be driven by supply chain pressures, variability concerns, and the need for more rapid, quantitative data capable of supporting continued process verification and requalification activities for biodecontamination. While adoption remains at an early stage, the level of engagement for this webinar and the nature of the questions submitted very much suggest that enzyme indicators are being actively assessed as part of modern VPHP validation strategies across the industry. Continued webinars, publications, and transparent discussions on the implementation of rapid, alternative methods will be essential to supporting this progress. Stay tuned for more!
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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