HYPER®

Your reliable partner in 6 log bio-decontamination processes

HYPER® is a Vapour Phase Hydrogen Peroxide (VPHP) generator specifically designed to perform bio-decontamination processes of clean, dry, sealed enclosures used in medical, pharmaceutical and biological applications.

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General Description

HYPER® works in single pass (open loop) configuration to achieve very fast bio-decontamination cycles.

HYPER® is controlled by a Siemens PLC S7-1200 to ensure a safe control process and generate a complete bio-decontamination cycle report.

Communication with the isolator’s control system via PROFINET or discrete I/O.
Depending on your configuration, HYPER® can be either integrated into the isolator system or remoted in technical areas.

To minimize operators’ exposure to the liquid hydrogen peroxide during handling of bulk product, HYPER® uses specially designed disposable containers containing 3.000 ml of 35% Hydrogen Peroxide (H2O2).

The bio-decontamination process is effective against a wide range of microorganisms. Processes can be validated with Geobacillus stearothermophilus biological indicators to routinely achieve 6-log sporicidal reduction.

Cycle Description

The bio-decontamination process is a dry process resulting in no condensation of VPHP onto treated surfaces.

HYPER® provides a low temperature bio-decontamination method, in which an aqueous solution of 35% H2O2 is flash vapourized into a (pre)heated air stream, which enters the enclosure enriched with VPHP.

 

The cycle can be divided into four main phases:

 

VPHP cycle description

Dehumidification
Dry, High Efficiency Particulate Air (HEPA) filtered air is delivered to the enclosure to lower the relative humidity down to a predetermined level.
This phase permits the necessary target VPHP concentration to be maintained below saturation (dew point) levels during the Rising and Plateau phases.
Rising
The flow of dry, HEPA filtered air continues while H2O2 is injected into the air stream.
The injection rate is controllable in the 0.0 to 30.0 grams per minute range, thus allowing to reach the target VPHP concentration in the fastest way possible.
Rising time is affected by injection rate, airflow rate, enclosure volume, enclosure contents and temperature.
Plateau
The enclosure is constantly furnished with a VPHP enriched air volume from the generator, while the exhaust system extracts the same volume to a “safe area” or to an external VPHP catalysing system. The catalytic converter degrades the VPHP antimicrobial into oxygen and water vapour. The target VPHP sterilant concentration, reached at the end of the rising phase, is maintained for a specific time throughout the enclosure. Plateau time is affected by injection rate, airflow rate, enclosure volume, enclosure contents and temperature.
Aeration
VPHP injection is stopped and the flow of dry, HEPA filtered air is delivered to the enclosure to reduce the concentration of H2O2 to a predetermined level.
Once such level is reached, the ventilation system of the enclosure completes the reduction of the VPHP concentration to a safe level (≤1ppm) by drawing a maximum air volume from the installation area and expelling the same volume to a “safe area” or to an external VPHP catalysing system.
© 2022 TEMA SINERGIE S.p.A
Fiscal Code n. 00970310397
Business Register of Ravenna n. 00970310397  |  R.E.A. 111877
Capital Stock € 2.000.000,00 paid-up