everything you need to know

FREQUENTLY ASKED QUESTIONS

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.

EI readers provide quantifiable, linear readings that provide users with substantially more information than the current BIs. Enzyme Indicators can act as early warning systems – allowing performance monitoring, threshold release and automatic data capture.

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 processed in our PR2A Luminometer. This is a robust reader with a small footprint and easily integrated into your lab work space.
EI’s provide the information needed to satisfy the audit process quickly and easily – and satisfy the regulator’s scrutiny.

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 are transported in temperature controlled packaging and must be stored in a standard refrigerator

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.

The cumulative variance of the Enzyme Indicator Technology is less than 15% This includes the PR2A Reader, the Enzyme Indicator strips and also the Reagent variation.

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

Standard lab conditions are adequate. EI’s should be processed at room temperature (20-25 °C). Direct sunlight should be avoided when processing.
Each EI takes around 60 seconds to process. Data is immediately available on the Athena Software.

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.

EI’s can be used to identify within one cycle run the precise distribution of the Hydrogen Peroxide throughout a whole chamber. This enable the swift identification of challenge locations.
Because EI’s are processed immediately after a decontamination cycle, there is no need to wait for 7 days. Consequently there is no need to mitigate batch release again.
The Enzyme Indicator is the ideal tool to streamline these processes. With results available within minutes after each cycle is run, the distribution, efficacy and development of a decontamination cycle can be optimised with quantitative data in under a week for FAT and again within a few days for SAT. Processes are streamlined and significant time savings are achieved.