Webinar Recording:
Enzyme Indicators as Standard in Cycle Development

Vaporised hydrogen peroxide (VPHP) bio-decontamination cycles are conventionally developed and validated using biological indicators (BIs) containing Geobacillus stearothermophilus spores. While BIs remain essential for Performance Qualification and requalification, their binary readout, lot-to-lot variability and the occurrence of rogue or late-positive results provide only limited insight into actual cycle performance.

Recorded 15 October 2026. Dr Birte Scharf of Franz Ziel GmbH on how a combined approach using biological indicators and Enzyme Indicators has been established as a standard for VPHP cycle development, hosted by Robin Hill-Walker of Protak Scientific.

This Session Covered:

Systematic BI pre-use qualification.
Quantitative EI mapping to identify and rank worst-case locations.
The parallel use of BIs and EIs in selected cycles.
The use of EI data to support the investigation of unexpected BI results.
Current limitations, and an alternative strategy for system-specific EI-BI correlation.

What The Approach Makes Possible:

Practical experience indicates that this strategy can:

Enable more targeted worst-case selection.
Reduce the number of development cycles or indicators required.
Provide a stronger scientific basis for cycle optimisation.

EIs do not replace BIs or override positive BI results, but they add rapid, quantitative information that is not available from conventional BI testing alone.

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Speaker:

Dr Birte Scharf

Senior Scientist GMP Compliance, Franz Ziel GmbH

Dr Birte Scharf has eleven years of pharmaceutical background and six years working experience in aseptic processing technologies. Birte combined her passion for science and technology through working for Franz Ziel GmbH, a partner of Körber and provider of aseptic processing solutions. As a Senior Scientist in the GMP Compliance Team she focusses on GMP compliant process integration and on science and compliance of R&D projects at Franz Ziel.

Franz Ziel GmbH

Co-host, partner of Körber

Franz Ziel GmbH, a partner of Körber, is your provider for aseptic processing solutions, including GMP-compliant isolator technology, GMP compliance services, and supporting and complementary laboratory services. Their earlier study on Enzyme Indicators using Fractional Kill Time methods was published in EJPPS.

Resources

Enzyme Indicators

Read about the advantages and benefits of using our Enzyme Indicators for your H₂O₂ bio-decontamination validation processes.

BI vs EI

Biological Indicators vs Enzyme Indicators at a glance.

Case Studies

Presentations, white papers, webinars, shared articles, project summaries and product analysis.

Questions about your own cycles?

If you would like to talk through how this applies to your isolators, our team is happy to help.