everything you need to know
Enzyme Indicators are placed in “challenge locations” throughout the decontamination space. After the bio-decontamination validation cycle they emit light that can then be measured with a luminometer, giving measurable data as compared to the positive or negative results received with Biological Indicators. With Enzyme Indicators the results are immediate, unlike Biological Indicators that require a seven-day incubation period before results can be determined. So – no wasted work hours, faster validation planning and execution times.
Due to their non-viable status, routine use for instant Bio-decontamination efficacy information is possible for equipment release for production actitivies. This allows batch is verified immediately, and allows batch specific decontamination data availability to remove run at risk processes in-between requalification.
Enzyme Indicators result in efficiency gains in repeat cycle execution and reduce the risk of product rejection.
EI’s produce an immediate time saving when compared to BI’s. The results are available within 60 seconds of processing compared to a seven day wait. Batches can be released with confidence without the need to wait.
EI’s remove the need to use BI’s in triplicate and also completely removes the need for Chemical Indicators. Consequently the Indicator costs for a decontamination cycle are significantly reduced.
Users typically benefit from gaining 2-4 weeks of additional production time per region per year, enabling capacity to be increased.
The EI data is analysed through the Athena software which accompanies the PR2A Reader. The software can be installed onto any windows based laptop or computer.
Its simple and intuitive design with a traffic light system ensures a smooth user experience.
Enzyme Indicators are presented as a small 5mm x 50 mm strip. At the end of this strip is a gauze which contains the Enzyme.
EI’s are handled as you would any other chemical or biological indicator. It is recommended that users wear sterile gloves for both placement and retrieval.
Placement of the EI’s is directly from the Tyvek pouch they are supplied in. Retrieval is immediately into the Luminometer Tubes which are also provided.
Good lab Practice is all that is needed to perform efficient readings, however, keep strips and reagents away from probable microorganism contamination where possible.
User PPE is a requirement as is the need to ensure no AK on gloves.
Enzyme Indicators have a shelf life of 9-12 months from the date of manufacture.
The PR2A reader can be seen here. It has a very small footprint and can easily be integrated into any lab.
Enzyme Indicators contain no bacteria and present no toxicological risk. On that basis they can be used in any part of any process.
The Enzyme is applied to the strip using a highly efficient and sensitive delivery method ensuring uniformity. The association of ‘rogue results’ as is the norm with BI’s is not applicable to EI’s.
They are manufactured to eliminate rogue results and include an optional onsite self-validation process.
All BI and EI are dynamically affected by droplet size. Clear science exists to show how H2O2 efficacy and biological inactivation is affected by droplet size.
It is necessary to correlate and understand process performance and the subsequent effect on biological inactivation
EI’s can help to rapidly develop and optimise a decontamination cycle. There is no need to wait 7 days for results before making adjustments.