Increased performance assurance enabling optimised cycle design reducing cost, saving time and improving efficiency
Enzyme Indicators offer benefits in the following core pharmaceutical disciplines such as Technical (Sterility assurance), Quality Assurance, Engineering or Validation, Production, Research & Development, Medicinal product manufacture including cell and gene therapy, Biotherapeutics and Biosafety.
Advantages and benefits of using Enzyme Indicators for your bio-decontamination processes:
With Enzyme Indicators bio-decontamination processes are assessed prior to production starting and product being committed which allows for re-processing if the decontamination were to fail. No product has to be destroyed due to failed decontamination cutting costs and waste.
Enzyme Indicators assure complete, controllable decontamination performance verification for all manufacturing processes. The product is not released without decontamination assurances, there are less product recalls and a full product manufacturing and decontamination history is available.
We’ve developed Athena 2.0 our bespoke software that delivers real-time, quantifiable results for cycle efficacy with FDA CFR part 21, part 11 compliance reporting.
Athena is used alongside Enzyme Indicators to deliver advanced reporting capability, enhanced audit and review features along with data archive facilities during validation cycles. It can act as an early warning system allowing proactive execution and planning to occur.
Verification using Enzyme Indicators will highlight a decline in decontamination performance before it reaches a critical set-point. Preventative maintenance can be carried out before risk to batch processing occurs and the product has to be destroyed.
When high-value products are handled, the risk of validation failures can lead to expensive and lengthy failure investigations – leading to lost production hours and potential batch rejection.
Enzyme Indicators eliminate the traditional ‘run to fail’ validation approach as data is provided instantly.
The quantifiable results enable optimisation of cycle design based on data.
As Enzyme Indicators can be positioned in multiple and often critical locations they offer significant advantages where bio-decontamination is used in complex environments such as cleanrooms, isolators, Restrictive Access Barriers (RABs), transfer chambers and laboratories.
Watch this webinar
Melanie Eggers, Sterilisation Validation Project Support Engineer at Pfizer Belgium, explains how Pfizer has adopted Enzyme Indicator (EI) technology for its VHP bio-decontamination procedures. She outlines the differences in EIs compared to more traditional Biological Indicators and the way in which Pfizer utilises the technology. Melanie also explores how the detailed data EIs provide assist with cycle development, requalification, investigations and validation.
Athena™, our bespoke software is used alongside Enzyme Indicators to deliver advanced reporting capability, enhanced audit and review features along with data archive facilities during validation cycles and the delivery of “challenge area” design specific reports that can be analysed against the facility design specification during handover testing and shared with your clients to inform future design modifications.
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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