Table Of Contents
- When is it necessary to Decontaminate Cleanrooms?
- The Vapor Phase of Hydrogen Peroxide (V-PHP)
- Vaporized Hydrogen Peroxide Bio-decontamination Process
- Cycle Development
- Why Amira’s BIORESET VHP Generators?
Cleanrooms are one-of-a-kind production areas that are free of contamination.
Cleanrooms are designated areas where the presence of germs and inert particles is guaranteed to be less than a certain quantity per unit of volume.
Bacteria, fungi, and protozoa are microorganisms that live in the air and on surfaces, and they, like some viruses, can survive in space.
Bioaerosols are airborne contaminants that bond to dust, liquid particles, and other naturally existing contaminants.
Cleanrooms are intended to minimize the introduction, creation, and retention of airborne particles inside the ambient environment, allowing activities that are sensitive to contamination.
Smooth, waterproof, and uninterrupted surfaces, steel furnishings, beveled edges, and low particle release materials must all be used to minimize the entry of particulate sources.
To avoid the entrance of potentially contaminating inverse flows, cleanrooms are designed using "dynamic containment" technology.
The atmosphere of the rooms is kept under constant overpressure and managed with an increasing gradient towards the areas with the maximum cleanliness.
Pressure gauges are used to measure differential pressures continuously.
Environmental contaminants must be entirely removed from clean rooms, including any form of biological contaminant, whether in the air or on surfaces.
Cleanroom decontamination is necessary if the sterility has been compromised.
Using a dependable and verified room bio-decontamination service lowers the danger of your product or the environment becoming contaminated.
When is it necessary to Decontaminate Cleanrooms?
The following considerations must be taken into account while deciding on the best decontamination method:
- Efficacy:
It is critical to have consistent and reliable performance against various organisms, particularly those that are difficult to deactivate (such as tuberculosis and anthrax).
- Fully Documented:
To maintain compliance, detailed, professionally produced reports are required to ensure method traceability and process validation.
- Speed:
Quick decontamination cycles cut down on plant downtime and lower operating expenses.
- Materials Compatibility:
1. Formaldehyde
2. Ozone
3. Ethylene Dioxide
4. Nitrogen Dioxide
5. Chlorine Dioxide
6. Hydrogen Peroxide (Dry Fogging)
7. Vaporized Hydrogen Peroxide (Gas)
There are two different methods of Hydrogen Peroxide that can be utilized for Bio-decontamination; however, the use of each of them has pros and cons over one; before that, let us try and understand both processes:
Hydrogen Peroxide Mist/ Aerosol/ Spray/Dry Fog:
One may find this process under different names; however method remains the same.
The use of liquid H2O2 With 50 ppm silver ions, 50 ppm phosphoric acid, and 1 ppm Arabica gum as catalysts, a commercial system creates a fine mist (particle sizes between 8 and 10 microns) of 5 percent hydrogen peroxide in air.
The aerosols disintegrate with time, the hydrogen peroxide reacts, and the situation decreases to a safe level. There isn't a lot of published proof. This method is most economical however has a lot of limitations of its own.
Non-condensing Vapor:
The hydrogen peroxide (usually at a concentration of 35 percent) is vaporized using a specially designed vapor generator under carefully controlled temperature, humidity, and pressure conditions, ensuring no condensation occurs in the subjected area.
This state is maintained in the enclosure for a long time, during which ultra-deadly hydrogen peroxide concentrations in the air are maintained for disinfection.
This is the most crucial stage in terms of microbial kill.
Finally, the enclosure is purged with air (catalytic aeration) until the hydrogen peroxide concentration is below the product exposure limit (as a safety indicator).
Vapor | Aerosol, Spray, Dry Fog... |
In physics, a vapor is a substance in the gas phase at a temperature lower than its critical point, which means that the vapor can be condensed to a liquid by increasing the pressure on it without reducing the temperature. | An aerosol is a suspension of tiny particles of liquid, solid, or both within a gas. |
Easy to distribute | Not easy to distribute |
No residues | Residues after evaporation |
High material compatibility (gas) | Possible compatibility risk for material (liquid) |