EI’s vs BI’s
EI's v BI's
Enzyme Indicators 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.
The results with Enzyme Indicators 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 specific decontamination data availability to remove run at risk processes between requalification.
INSTANT RESULTS VS A 7-DAY INCUBATION
Decontamination cycle performance can be measured instantly unlike the traditional Biological Indicator process which involves a wait of 7 days before a result is known, every cycle using EI’s can be validated immediately and decontamination performance assured. Faster product release, each batch is verified immediately, and batch specific decontamination data is delivered.
QUANTIFIABLE DATA RATHER THAN BINARY RESULT
Enzyme Indicators offer linear, numerical values of performance which can generate long term statistical data including any subtle process performance changes.
EI technology allows for capture of data from the PR2A luminometer reader that can then be stored electronically reducing the risk of manual data records.
100% PERFORMANCE ASSURANCE VS RISK OF FALSE POSITIVES
When high-value products are handled, the risk of false positives biological indicators that can lead to expensive and lengthy failure investigations – leading to lost man hours and potential which can often lead to batch rejection.
The EI’s automated manufacturing process eliminates this risk to provide an accurate holistic view of the Bio-decontamination process.
RE-PROCESS BATCHES VS WASTED PRODUCT
With EI’s 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.
tAK assures 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.
PROACTIVE PREVENTION OF DECONTAMINATION FAILURE VS REACTIVE
Due to the data captured by Enzyme Indicator technology, it can act as an early warning system allowing proactive execution and planning to occur.
tAK verification will highlight a decline in decontamination performance before it reaches a critical set-point. Preventative maintenance can be carried out before risk to batche processing occurs and the product has to be destroyed.
