Enzyme Indicators for Validation and Monitoring VH2O2 Cycles
Enzyme Indicators (EIs) are a major step forward in measuring the performance or efficacy of bio-decontamination cycles with vaporized hydrogen peroxide (VH2O2).
The indicator is based on an enzyme, thermostable Adenilate Kinase (tAK), which has a high tolerance to high temperatures and/or oxidizing chemical agents that would quickly inactivate most proteins. This enzyme has a predictable inactivation pattern, like the mortality rate of a spore population. Its presence and activity can be measured using a fast and sensitive luminescence test.
This technology offers key advantages versus the traditional biological indicators:
Reliability – EIs have a low level of variability between batches and therefore do not give false positive problems (rogue BIs)
> Instant Results – The effectiveness of the biodecontamination process can be obtained in a few seconds, using a luminescence reader that provides RLU (Relative Light Units) data, which can be correlated with the logarithmic reduction achieved
> Accurate Data Capture – The luminometer provides quantifiable, linear data that provides the users with information substantially more valuable than the current BIs. EIs can act as early warning systems, enabling performance monitoring or threshold detection for cycle optimization
> Simple y fácil de usar – Los indicadores enzimáticos son sencillos y fáciles de usar y por lo tanto pueden ser utilizados regularmente por técnicos y usuarios tanto en hospitales como en industria farmacéutica
> Audit Process Support – Validation with enzyme indicators provides the information needed to pass an audit process quickly and easily and meet regulatory scrutiny
> Reliability – EIs have a low level of variability between batches and therefore do not give false positive problems (rogue BIs)
Today, the major pharmaceutical companies are using enzyme indicators for the following applications:
VH2O2 Cycle Development – When used in the early stages of cycle development, it allows to quickly detect, in a matter of seconds, the points of least exposure to hydrogen peroxide.
VH2O2 Cycle Validation – Enzyme indicators can be used to validate cycles by correlating them with a biological indicator of reference.
Routine Monitoring of VH2O2 Cycles – This practice is absolutely recommended when environmental conditions vary from cycle to cycle or the dosage to be used is a function of them.
> VH2O2 Cycle Development – When used in the early stages of cycle development, it allows to quickly detect, in a matter of seconds, the points of least exposure to hydrogen peroxide.
> VH2O2 Cycle Validation – Enzyme indicators can be used to validate cycles by correlating them with a biological indicator of reference.
> Routine Monitoring of VH2O2 Cycles – This practice is absolutely recommended when environmental conditions vary from cycle to cycle or the dosage to be used is a function of them.
