Since decontamination cycle performance is measured instantly, Enzyme Indicators should be the ONLY considered solution in the medical and pharmaceutical industries. 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. So – no wasted man hours, faster product release, each batch is verified immediately, and batch specific decontamination data is delivered.
Enzyme Indicators offer linear, numerical values of performance which can generate long term statistical data including any subtle process performance changes, for a fraction of the cost of doing the same thing with BI’s. EI technology allows for capture of data from a reader that can then be stored electronically. This is not the case with BI’s where a 7-day incubation period and manual processes are a huge barrier.
One of several concerns with BI’s, especially when high-value products are handled, is the risk of false positives that can lead to expensive and lengthy failure investigations – which can often lead to batch rejection. EI’s are manufactured to eliminate rogue results and include an optional onsite self-validation process.
With EI’s using tAK, decontaminations are validated before being released which allows for re-processing if the decontamination were to fail. The result is that no product has to be destroyed due to failed decontamination because microbiologists can reprocess the decontamination procedure before continuing their work. tAK assures complete tractability and 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.
Due to the linear data captured by Enzyme Indicator technology, it can act as an early warning system for microbiologists. tAK verification will highlight a decline in decontamination performance before it reaches a critical set-point. Preventative maintenance can be carried out before batches are failed and the product has to be destroyed. With conventional Biological Indicators, there is no history record or advanced data on decontamination performance in an environment and therefore proactive action is limited and time and money is wasted.