Webinar Recording:
Understanding Your Cycle: Continued Process Verification for VPHP Bio-decontamination

Most isolator cycles have run unchanged for years, and almost nothing in-house explains why they work. When one fails, the answer is a pass or a fail, the investigation runs longer than expected, and the data that would have explained it was never gathered.

Recorded 9 September 2026. Vanessa Vasadi Figueroa of VVF Science explains why cycles vary and what it takes to defend one. “If you can’t explain your challenge map for your VPHP cycle, it isn’t defensible.” Kate Marshall of Protak Scientific and Daniel Østerby of Moderna pick it up from there, hosted by Robin Hill-Walker.

More than fifty questions came in with registrations, and more than fifty again during the session. Three polls went to the room. Asked what would make the biggest difference to their cycle next year, 64 of 71 chose confidence in cycle consistency or better evidence for audits and inspections. Five chose shorter cycle times.

This Session Covered:

Why two isolators running the same cycle do not behave the same way, and what geometry, load, materials, humidity and temperature do to it.
Why biological indicators remain the qualification benchmark, and what a pass or a fail still cannot tell you about where the process sat.
One anonymised site end to end, shared with permission: distribution mapping across worst-case loads through to routine monitoring between periodic qualifications.
What a good biological indicator strategy looks like now, and how far it has moved from three indicators in every location.
Whether a site can lean on an existing enzyme indicator to biological indicator dataset, or has to build its own.
Why a 6-log reduction at the challenge locations does not by itself let you claim sterilisation of a stopper bowl.

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Speakers:

Vanessa Vasadi Figueroa

Chief Executive Microbiologist and Independent Consultant, VVF Science

Over 20 years in sterility assurance, aseptic processing and contamination control. Vanessa presented the technical segment and the case study.

Kate Marshall

Technical Director, Protak Scientific

Pharmaceutical microbiologist leading Protak’s Enzyme Indicator team, with almost twenty years at GSK as a regulatory SME with the MHRA and FDA. Kate brought the on the ground view of enzyme indicator implementation, including what the first call sounds like after an unexpected result.

Daniel Østerby

Global Head of Sterility Assurance, Moderna

Dan gave the manufacturer’s perspective, drawing on his general industry experience across sterility assurance.

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.

How to get Enzyme Indicator Technology

Protak Scientific manufactures Enzyme Indicator technology. To find out more, contact us to arrange a presentation with a member of our team. We will get to know your individual bio-decontamination challenges and requirements, delivering solutions to support your validation strategy.

Webinar Recording:Understanding Your Cycle: Continued Process Verification for VPHP Bio-decontamination