BioClean vHP Hydrogen Peroxide Application Process:

Effective application of vaporized hydrogen peroxide requires adequate vHP concentration and exposure time. The vHP applicator is utilized to achieve the concentration and contact time of hydrogen peroxide on exposed surfaces within the enclosed area. The process parameters are controlled through the use of the control panel on the vHP Generator, along with effective hydrogen peroxide monitoring systems. See the vHP generator equipment user’s manual prior to initiating the application process to determine the appropriate steps to take in development and application of the process.

The vHP Generator uses air as a carrier to deliver hydrogen peroxide vapor to exposed surfaces inside a sealed enclosure. This allows the process to take place at, or near, atmospheric pressure. Since the vHP process relies only on the contact of the vHP solution with exposed surfaces, the transfer of heat and moisture required by steam or chemical processes is not necessary.

The vHP Biostat is continuously injected for the required exposure time to maintain the desired concentration of hydrogen peroxide vapor. Once the vHP Biostat leaves the enclosure, it is typically broken down into water vapor and oxygen.

The vHP process consists of four phases:

• DEHUMIDIFICATION – Dry air is circulated in the sealed treatment enclosure to reduce humidity to a
predetermined level in the 10 to 70% relative humidity range. This permits the target vHP concentration to be maintained below condensation levels during the CONDITIONING and TREATMENT (Biostatic) phases. The time to reach the targeted dehumidification level increases with the volume of the enclosure, and is dependent on environmental conditions.

• CONDITIONING – The vHP Biostat is injected into the air stream. The CONDITIONING phase facilitates
reaching the desired vHP concentration in the sealed enclosure. CONDITIONING time is affected by vHP target concentration, injection rate, enclosure materials, environmental conditions and enclosure volume.

• TREATMENT – The BioClean vHP Solution is continuously injected at a selected rate to maintain the target vHP concentration over a pre-established period of time.

• AERATION – The vHP injection is stopped and the flow of dry air continues to reduce the vHP concentration within the enclosure to at or below one ppm level (< 1.0 ppm TWA 8 hr.) prior to reentry into the enclosure by trained applicators. Treated enclosures may not be released for general public use until the level of hydrogen peroxide is at/or below one ppm (one part-per-million) within the enclosure.

USER SAFETY REQUIREMENTS:

1. Respirator Requirements – When a respirator is required for use with this product, the trained applicator
supervising the fumigation must make sure that:

a. Respirators must be fit tested and fit checked using a program that conforms with OSHA’s requirements (described in 29 CFR Part 1910.134).
b. Respirator users must be trained using a program that conforms with OSHA’s requirements (described in 29 CFR Part 1910.134)
c. Respirator users must be examined by a qualified medical practitioner to ensure the physical ability to
safely wear the style of respirator to be worn.
d. Respirators must be maintained according to a program that conforms with OSHA’s requirement (described in 29 CFRPart 1910.134).

2. Concentrated liquid hydrogen peroxide is corrosive and will cause irreversible eye damage or skin burns and may be fatal if inhaled at higher concentrations. It is also harmful if swallowed or absorbed through skin. Do not get in eyes, on skin or on clothing. Do not breathe spray mist or vapor above 1-pm. Prolonged or frequently repeated skin contact of the active solution may cause allergic reaction in some individuals. User should wash hands before eating, drinking, chewing gum, using tobacco or using the toilet. User should remove contaminated clothing and wash before reuse. Discard clothing and or absorbent material that has been heavily drenched or contaminated with concentrated liquid hydrogen peroxide.

3. Follow manufacturer’s instructions for cleaning/maintaining protective eyewear and respirators.

4. User Safety Recommendations:
a. Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet.
b. Users should remove clothing/PPE immediately if hydrogen peroxide gets inside. Then wash thoroughly and put on clean clothing.
c. Users should remove PPE immediately after handling this product. Wash the outside of gloves before removing. As soon as practical, wash thoroughly and change into clean clothing.
d. Mobile carbon monoxide testing and monitoring is mandatory when a gasoline powered vHP unit is in operation.

EFFICACY:

35% Active Hydrogen Peroxide is accepted by the US EPA as an effective Sterilant , Sporicide, Bactericide, Virucide, and Fungicide under the following conditions on exposed, pre-cleaned, dry, porous [NOT APPROVED IN CALIFORNIA FOR EFFICACY ON POROUS SURFACES] and non-porous surfaces including floors, walls, furniture, equipment and other items in sealed enclosures in industrial, commercial and institutional settings (including production operations in pharmaceutical manufacturing, manufacturing clean rooms, medical device treatments part of a manufacturing process, educational facilities, laboratories, animal research facilities, patient rooms, hotel rooms, offices, cruise ships, recreational facilities and emergency response vehicles) when used with appropriate vHP application equipment.

Minimum Times and Solution Concentrations:

– As a Biostat, Sporicide, Bactericide, Virucide, and Fungicide at a minimum of 250 ppm of vHP Biostat
for 90 minutes in sealed enclosures up to 4,000-ft3.

– As a Biostat, Sporicide, Bactericide, Virucide, and Fungicide at a minimum of 400 ppm of vHP Biostat
for 30 minutes in sealed enclosures up to 4,000-ft3.

– For larger than 40 ft3 enclosures as a Biostat, Sporicide, Bactericide, Virucide, and Fungicide when used
in a validated application in accordance with use instructions.

This product is not to be used as a terminal high level disinfectant or Biostat for reprocessing of any critical/semicritical medical device in a healthcare setting. Not for use in residential applications.