An Enzyme (EI), in contrast to a Biological Indicator (BI), requires no incubation. EIs deliver their results within two minutes. The waiting game of BIs – the current gold standard – taking seven days in incubation is no longer necessary. This provides significant savings both in time and on the bottom-line.
A simple process, performed by a self-calibrating, fully-validated reader provides instant results.
EIs and tAK validation provide the information needed to satisfy the audit process quickly and easily – and satisfy the regulator’s scrutiny.
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.
Enzyme Indicators contain no bacteria and present no toxicological risk. On that basis they can be used in any part of any process. With a range of different versions available, Protak has a suitable indicator for all processes and many applications.
EIs are manufactured to eliminates rogue results and include an optional onsite self-validation process.
With tAK, decontaminations are validated before being released which allows for re-processing if the decontamination were to fail. No product has to be destroyed due to failed decontamination.
tAK verification will also highlight a decline in decontamination performance before it reaches a critical set-point. Preventative maintenance can be carried out before batches are failed and product has to be destroyed.
tAK doesn’t need incubation for seven days.
Result? – Speeds up product release, verifies each batch immediately, provides statistical and batch specific decontamination data.
tAK provides immediate cycle validation capability.
Result? Provides a level of assurance not previously available for each batch.
tAK assures complete tractability and decontamination performance verification for all manufacturing processes.
Product is not released without decontamination assurances, less product recalls and a full product manufacturing and decontamination history is available.
tAK will remove uncertainty and save considerable expense on many levels of pharmaceutical production.