The Validation and Process Parameters Verification Kits – a Description

Hila Frank Scientific Project Manager 30.07.2019

When discussing process validation, we are referring to routine monitoring of the sterilization process performance. The aim of the routine monitoring is to allow a validation of the sterilization process (meaning performing sterilization to STAATT IV).

Additionally, when conducted in parallel with parametric monitoring (temperature, time and concentration of the active substance), it aims to re-validate the parameters values at which the sterilization process was initially validated.

At Envomed, we can supply kits for a fast and easy self-validation and process parameters verification performance.

The self-validation kit contains 106 Geobacillus stearothermophilus ATCC 7953 spores adhered to a strip, and an indicator growth media that is especially designed for Geobacillus stearothermophilus culture. The spores are exposed to the Biocide according to the established process parameters. Following this, the spores are incubated for 24 hours at 60°C within the indicator growth medium. Once bacterial growth has occurred, it can be detected by the media color change.

Additionally to the routine validation testing kit, Envomed can provide a kit for the reassurance of the BIOCETIC‘s active substance concentration (PAA).  The kit consists of an indicator strip printed with a brown reactive ink especially designed for PAA monitoring, contained within an envelope of non-absorbent material which prevents direct contact of the reactive ink with the aqueous medium.

The reactive ink is exposed to the complex of sterilization process parameters (PAA concentration (ppm), temperature (°C) and time (min)). If all parameters reached established values, a “correct” answer would be returned by the reactive ink. If one of the parameters have not complied with its established value, an “under exposure” or an “over exposure” results will appear. Answers of “Over exposure” or “Under exposure” returned by the reactive ink could help you detect an error in the system before the initiation of your working day.

The kits described above, assure a safe and monitored sterilization process.


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