Dr Birte Scharf of Franz Ziel on how a combined approach using biological indicators and Enzyme Indicators has been established as a standard for VPHP cycle development.
Dr Birte Scharf, Senior Scientist GMP Compliance, Franz Ziel GmbH · Co-hosted by Protak Scientific
The situation
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.
What we will cover
Over the past year, a combined approach using biological indicators and Enzyme Indicators (EIs) has been established as a standard for cycle development. This presentation describes how the approach was implemented.
What you will leave with
Practical experience indicates that this strategy can:
The speaker
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.
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.
The technology
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.
A scientifically justified combined approach is therefore needed that uses the complementary strengths of BIs and EIs without weakening the established role of BIs in cycle qualification.
Protak’s Enzyme Indicator is quantitative and non-viable, and returns a result in approximately 60 seconds rather than days.
Who should attend
Validation, quality assurance and engineering professionals working with isolators, RABS and VPHP bio-decontamination in aseptic manufacturing.
Particularly relevant if you are developing or requalifying a cycle, or if you have had BI results you could not explain.
Questions
An Enzyme Indicator is a rapid, quantitative indicator placed inside the chamber alongside biological indicators during a VPHP bio-decontamination cycle. It gives a quantitative readout of hydrogen peroxide exposure at each position in approximately 60 seconds, with no incubation period.
No. Biological indicators remain essential for Performance Qualification and requalification. Enzyme Indicators add rapid, quantitative data during cycle development and investigation. They do not override a positive BI result.
A rogue or late-positive biological indicator returns a positive result without a corresponding process failure. Rogues are a known phenomenon and, statistically, even a low incidence rate can affect the outcome of a Performance Qualification, particularly where large numbers of indicators are used.
VPHP stands for vaporised hydrogen peroxide. It is the method used to bio-decontaminate isolators, RABS and filling lines in aseptic pharmaceutical manufacturing, and the cycle is validated using biological indicators containing Geobacillus stearothermophilus spores.
Annex 1 permits alternative methods where equivalence or superiority is demonstrated, and says rapid and alternative methods and continuous monitoring systems should be considered. Enzyme Indicators complement biological indicators rather than replacing them in qualification.
The session covers work carried out by Franz Ziel on their own isolator systems. The correlation approach discussed is system-specific and depends on isolator design, gassing technology, indicator lot and loading condition.
About
Protak Scientific provides validation lifecycle services for hydrogen peroxide bio-decontamination, backed by proprietary Enzyme Indicator technology. The Enzyme Indicator returns a quantitative result in approximately 60 seconds rather than days, and is in use across the pharmaceutical and life sciences industries worldwide.
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.
14:00 to 15:00 BST. Zoom, 60 minutes, with live polls and open Q&A.
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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