Identifying Worst-Case Locations and Assessing Homogeneity Using BIs and EIs

About this session

Protak Scientific and SKAN are bringing together two complementary areas of expertise for a webinar on H₂O₂ isolator cycle development. If you’re working through cycle development, approaching requalification, or trying to build a more defensible validation strategy, this session offers real-world insight into how adding quantitative tools, Enzyme Indicators and CFD modelling, alongside Biological Indicators can give you a clearer picture of what’s happening inside your isolator, reduce uncertainty, and strengthen your evidence package. Presented by specialists from both organisations, this is a session grounded in application, not theory.

The session will cover:

  • Practical validation challenges in isolator and barrier systems
  • Lessons from real-world applications
  • Case study: bio-decontamination homogeneity assessment using EIs and CFD simulations
  • How quantitative EI data can strengthen qualification and requalification strategies alongside BI data

Register:

15 April 2026 | 2:00 PM GMT

Online via Zoom Register using the link below.

Speakers:

Theresa Ladwig

Sterility Assurance Services Manager, SKAN

Theresa Ladwig has been with SKAN since 2007, bringing extensive expertise in cycle development, microbiological qualification, and process validation across global projects. After leading microbiology validation and supporting European sales, she now focuses on the strategic development of SKAN’s process validation microbiology and SKANalytix service offerings.

Martin Novák

Technology Lead, SKAN

Martin Novák has more than 10 years of experience in pharmaceutical R&D, with a background in drug synthesis and manufacturing. As Technology Lead at SKAN, he plays a key role in advancing decontamination strategies and isolator technology, and contributes to international standardisation as well as industry initiatives within PDA and ISPE.

Christopher Horne

Researcher, SKAN

Christopher Horne has five years of pharmaceutical R&D experience, with a focus on H₂O₂ decontamination research, sterility assurance, and biologics characterisation. He leads and is involved with various research projects, contributing to the advancement of decontamination strategies.

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.