Blog: vH2O2 Generation & EU GMP Annex 1

Dr Hemalatha Beesetti | Chief Scientific Officer

PART 1 of 3

What is vH2O2 (VHP) bio decontamination?

Vaporized Hydrogen Peroxide (vH2O2) is a process that provides low-temperature bio decontamination of all microorganisms and their spores. It's a highly versatile gaseous agent that provides excellent coverage and permeates into hard to reach areas with an extensive reach over all surfaces.

Depending on conditions such as volume of the treatment area (m3), RH%, RS% and temperature typically 300 to 800 parts per million (ppm) can be generated efficiently to kill all microorganisms and spores in the area and it’is a highly effective disinfectant that can be used to decontaminate a wide variety of surfaces and equipment.?

How does vH2O2 decontamination work?

vH2O2 gas generates Hydroxyl Radicals and Superoxide Anions that oxidise the cell contents, breaking down the structure and function of internal &? external cell components by disrupting their cell walls. When a vH2O2 gas molecule comes into contact with a microorganism, it penetrates the cell wall and disrupts the cell's metabolism and its ability to reproduce and function so the microorganism dies.

vH2O2 molecules at 0.25nm are much smaller than all target microorganisms, one of the smallest viruses is Norovirus at 38 nm, then Adenovirus and Arenaviruses (Lassa) at 100 nm,? Coronavirus is 200 nm, with the larger M.Tuberculosis at 1μ.? Consider that a? fogger (fumigation) aerosol molecule is typically 10μ, some claim as small as 3μ? but even then having much larger molecules their dispersion is greatly affected by gravitational force, thus limiting a complete diffusion of the biocide in the treatment area and its ability to destroy target microorganisms. However the much smaller 0.25nm vH2O2 molecules are vaporous and not limited by gravity & freely permeate throughout the treatment area, destroying all microorganisms including their spores present on surfaces. It’s important to note that the small vH2O2 molecules can also pass through HEPA filters which offer advantages for pharma production and healthcare.

What are the benefits of using vH2O2 biodecontamination?

vH2O2 decontamination is a highly effective and efficient way to decontaminate a wide variety of surfaces and equipment. It is also an environmentally friendly process. vH2O2 breaks down into its constituent parts of oxygen and water vapour, so there is no risk of harmful residual chemicals that leave corrosive traces and that can cause harm or irritation to people or potential damage to sensitive electronic equipment e.g medical equipment, instrumentation etc.

Because it's a dry non saturated gas the decontamination cycle times are much faster, typically in a healthcare scenario it would take a few hours whereas fumigation or fogging which employs wet aerosol based solutions take much longer. Apart from the harmful environmental impact from the biocides used, the treatment area often has to be closed for a 24 hour period mostly due to the need for aeration to allow the residues to dry before any human contact is permitted. So a valuable asset like an OT is out of action for 20 hours longer than need be.

Broad material compatibility, friendly even with the most sensitive materials like electronic instrumentation and medical / lab equipment; sensors, monitors, actuators etc which results in longer lifetime for these devices or just that they can be effectively included in a decontamination cycle? when using vH2O2 rather than using harmful? liquids/aerosols

vH2O2 permeates into hard to reach areas with an extensive reach over all surfaces able to decontaminate any type of environment? that include electronics and devices that pose a threat to contamination control? where there are miniscule crevices and gaps that can serve as potential reservoirs for microbes. Furthermore, conventional cleaning methods are unable to access these areas and if they do they are usually corrosive and cause damage.

What are the particular benefits of using CLEAMIX bio-decontamination equipment?

One of CLEAMIX's key innovations lies in the use of advanced sensors from Vaisala, which accurately measures Relative Saturation RS% among other parameters.

Measuring RS% allows the software to maintain real-time control over the decontamination process, ensuring an environment that prevents vapour saturation and potential corrosive damaging residues that could result in potential damage to sensitive electronic equipment and contamination of product in pharmaceutical production as well as harm and irritation to people.

• The prevention of vapour saturation through the sophisticated Cleamix closed loop control software which constantly monitors real-time sensor data (temperature, RH%, RS%, vH2O2 concentration in ppm).? controlling the production of the hydrogen peroxide vapour levels to guarantee the ppm target level, treatment profile as well as prevent vapour saturation?
• Reduced treatment cycle times because a pre dehumidification phase is usually not required and a quick aeration phase..
• Does not require compressed air feeds for vapour distribution.
• Minimal running costs with consumables, firstly because we are much more efficient with the generation of? vH2O2 from liquid at over 90% efficient with better “mileage” so with just 1 litre of H2O2 we can decontaminate for more than 6 hours at full power. But also because we don't require the use of our own branded H2O2 liquid, just the use of a PT4 food grade or equivalent between 35-50% concentration which? typically costs cents per litre as opposed to over USD100 per litre of proprietary consumables from “incumbent” vendors.

In the next Part 2 of 3 we will cover vH2O2 Process Steps