Biological Indicators vs Enzyme Indicators at a glance

Biological IndicatorsEnzyme Indicators
Time for results> 7 days60 seconds
Data availableBinaryQuantitive values
Variation-50-300%< 15%
SourceBacterial SporesEnzymes

Learn how Pfizer use Enzyme Indicators to speed up Biological Indicator validation

    The differences between EI and BI

    Enzyme Indicators offer a range of advantages over traditional Biological Indicators. One of the major benefits is Enzyme Indicators’ ability to provide clear, quantifiable results in seconds rather than days. This means users can have full confidence in the effectiveness of their bio-decontamination processes, which in turn leads to improved efficiency and reduced costs for these critical activities.

    Faster Results

    Traditional Biological Indicators require a seven-day or more incubation period before they can provide a result as to whether a gaseous bio-decontamination process has failed. By contrast, Enzyme Indicators give answers in just 60 seconds, providing for reduced costs, immediate batch verification and reduced risk that products will have to be destroyed.

    Detailed Insight

    Because Enzyme Indicators offer detailed, quantifiable data as opposed to the binary pass/fail information Biological Indicators deliver, this allows users to create data on their activities. In turn, this can be used to identify areas for bio-decontamination cycle improvement through our Athena™ software.

    Learn more about Protak’s work

    Pfizer

    How Pfizer utilises Enzyme Indicator technology for bio-decontamination validation

    Roche

    Enzyme Indicators in Aseptic Production Environment

    AstraZeneca

    Champions Enzyme Indicators

    Where can Enzyme Indicators be used?

    Pharmaceuticals

    Hospital Pharmacy and Compounding

    Contract manufacturing

    Universities And
research organisations

    Original equipment manufacturing

    Engineering

    Faster

    Bio-decontamination results in 60 seconds

    Smarter

    Immediate Quantifiable Results

    Safer

    Increased or Enhanced Performance Assurance

    Who are we?

    Protak Scientific is the manufacturer of a rapid validation technology for gaseous bio-decontamination using ‘Enzyme Indicators’, developed in collaboration with Public Health England
(now the UK Health Security Agency). One of our largest sectors is pharmaceutical manufacturing where we partner with over 80% of the largest pharmaceuticals.



    We provide validation consultancy to multiple sectors where bio-decontamination is critical to ensure safety and efficacy. Our Athena™ software delivers real-time quantifiable results for cycle efficacy, with advanced reporting capabilities and enhanced audit and review features that ensure all operations meet compliance requirements.

    These services help companies design manufacturing facilities, build bespoke equipment or manage quality assurance of pharmaceutical production, providing clients with the most effective method of bio-decontamination validation for any clean room setting or sterile environment.

    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.