Qualifying a bio-decontamination process can be a lengthy and complex undertaking – one that becomes even more challenging when a failure occurs.
A single failure can undo weeks of progress—forcing teams to re-examine the entire process and raising questions about risk exposure if the issue emerges during requalification.
When faced with these obstacles, one of the most common issue is not having sufficient detailed insight to refer back to, leaving you in the dark about what actions to take.
Many companies validate their processes using Biological Indicators (BIs). But what happens when they return a failure?
Traditional pass/fail methods tell you what went wrong but not why—or how close you were to failure. This information is critical in determining how to correct the problem, as it could be the difference between a minor adjustment or starting a brand-new cycle. This leaves you with one ultimate question:
When looking into a BI failure, it is essential to understand all the parameters that may have contributed to the issue. A key step in this process should be data gathering your entire validation process to answer questions such as:
Evaluating the data and identifying the issue is likely to be an extensive operation. During this time, you may also have to dedicate significant personnel and financial resources to solving the problem, leading to an increase in costs, production delays and mounting pressure on your team members.
Enzyme Indicators (EIs) transform how we approach validation. Mapping with EIs gives the opportunity to verify the efficacy of bio-decontamination processes, providing better insight into why a cycle performed the way it did. This precision allows teams to quickly pinpoint root causes, streamline investigations, and reduce costly downtime.
By replacing guesswork with actionable data, EIs enable a faster, more reliable, and more resilient bio-decontamination process. For companies under pressure to balance safety, efficiency, and compliance, this technology isn’t just an improvement—it’s the future of validation.
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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