Enzyme indicator strips are 5 x 50mm in size with the last 3mm containing the enzyme. At the end of this strip is a gauze which contains the Enzyme.
Protak’s Indicators contain an enzyme that is inactivated during the bio-decontamination process, translating this into real-time quantifiable results and data.
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.
Once removed from the decontamination area and inserted into the reader our Enzyme Indicators generate a bioluminescent reaction.
The first reagent, Luciferin and its enzyme partner Luciferase; are introduced to the process via injection into the test tube containing the indicator which acts as a marker of the enzyme and produces light.
To measure how much active enzyme is left, the second reagent ADP is introduced and as the residual tAK starts to convert the ADP into ATP, more light is produced.
At the introduction of the ADP the PR2A built in photometer captures the light reaction and generates a Relative Light Value. The higher the Relative Light Value, the more enzyme is left on the strip – which means that the bio-decontamination is less effective.
A lower Relative Light Value indicates less enzyme is left on the indicator, showing that the bio-decontamination is more effective.
This determines the effectiveness of the decontamination by highlighting the differences in location of any challenge areas used, leading to a model of bio-decontamination efficacy for the process and enclosure space that’s monitored.
Enzyme Indicators are used 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 a Tyvek pouch – something used extensively in medical packaging. 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.
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.
Enzyme 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.
Enzyme Indicators provide increased or enhanced performance assurance enabling optimised cycle design, reducing the risk of routine failures, improving production performance and providing safer bio-decontamination.
Protak’s validation process delivers quantifiable results in seconds, compared to the traditional validation tool with a 7 day incubation period, generating ‘challenge area’ specific data reducing cost, saving time and improving efficiency.
Using Athena™ – our bespoke software that delivers real-time, quantifiable results for cycle efficacy with full 21 CFR Part 11 compliance features.
The Athena software 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.
The data from our Enzyme Indicators is analysed through the Athena software which accompanies the PR2A Luminometer (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.
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
Reader Variation = <2% @ 1.5% CV from blank tube / luminometer read variance (PQ)
Test Strip Variation = < 10% (6.25% if subtracting Reader and Reagent variation)
Reagent Variation = <5% @ 3.65% (2.15 % CV if subtracting above reader CV)
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 provide the information needed to satisfy the audit process quickly and easily – and satisfy the regulator’s scrutiny.
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.
EI’s produce an immediate time saving when compared to BI’s. The results are available within 60 seconds of processing compared to a 7 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.