In this session, Protak Scientific and SKAN brought together two complementary areas of expertise to explore H₂O₂ isolator cycle development.
The session focused on real-world approaches to cycle development, requalification, and building more defensible validation strategies. It highlighted how combining quantitative tools such as Enzyme Indicators (EIs) and CFD modelling alongside traditional Biological Indicators (BIs) can provide a clearer understanding of what’s happening inside an isolator, helping to reduce uncertainty and strengthen validation evidence.
Presented by specialists from both organisations, the discussion was grounded in practical application rather than theory.
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.
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.
Researcher, SKAN
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 contributes to a range of research projects, supporting the advancement of decontamination strategies.
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.
Presentations, white papers, webinars, shared articles, project summaries and product analysis.
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