Biological Decontamination Testing
Hospitals and clinics in many regions of the world are seeing antibiotic resistant or un-treatable bacterial infections in patients due to inhalation transmission of diseases. This problem has driven the market to come up with innovative methods for safe, effective, and efficient bioaerosol decontamination processes. Novel and emerging technologies designed to reduce or eliminate the threat of infectious disease in hospitals and clinics, as well as threats against military personnel and civilians is crucial for human and economic stability. We can provide thorough biological decontamination testing with a broad range of bioaerosols to evaluate any system and give broad spectrum claims for FDA510(k) submissions.
Our expertise in characterization testing of biological decontamination methods that include: decontamination devices, filtration devices, spray disinfection, hand sanitizing lotions, and vapor generators. Testing can measure direct aerosol deactivation of microorganism and surface decontamination simultaneously.
Our engineers can set up single pass systems to challenge and measure biological decontamination efficiency or testing can be conducted in our stainless steel aerosol chamber to simulate real-world room environments. Our team can provide a wide range of challenge aerosols to measure your devices efficacy against a wide range of bioaerosols such as: vegetative bacteria, DNA & RNA viruses, biological warfare surrogates, mold spores and even common allergens. Testing will show challenge concentration & particle sizes, LOG kill as a function of time and measure the removal of airborne biological contaminants for FDA 510k submission
If you need biological decontamination testing ARE Labs Inc. can put together a testing protocol to obtain the critical data needed to validate the efficacy against a wide variety of biologically infectious agents.
Evaluating Bioaerosol Decontamination
Testing your device against multiple bioaerosol for broad agent validation of effectiveness
→ Formulate Preferred Test Configuration
→ Selection of Challenge Organism
→ Challenge Testing for Bioaerosol and/or Surface Decontamination
Full Evaluation of Biological Decontamination Testing Performance
Challenge bioaerosols: Bacteria, DNA & RNA viruses, molds, spore forming organism, pollen and more
Pathogenic Bacteria
Escherichia coli
Vegetative Cells
Testing against a wide variety of vegetative pathogenic micro organism and BSL2 surrogates. Typical aerosol particle size range form 1.2-2.5um in diameter with challenge concentrations unto 1 x 106 organisms per liter air. Testing usually used a surrogate gram + and gram – organsim for broad range effectiveness claims.
Viruses
Influenza Virus
DNA and RNA Viruses
Testing with DNA and RNA bacteriophages surrogates for pathogenic viruses such as Influenza and HIV. Native particle size from 50-300nm. Cchallenge bioaerosol particle size is usually 1-2.um due to buffer salts representing a real-world challenge scenarios.
Pathogenic Bacteria
Escherichia coli
Vegetative Cells
Testing against a wide variety of vegetative pathogenic micro organism and BSL2 surrogates. Typical aerosol particle size range form 1.2-2.5um in diameter with challenge concentrations unto 1 x 106 organisms per liter air. Testing usually used a surrogate gram + and gram – organsim for broad range effectiveness claims.
Endospores
Bacillus anthracis spores
Biowarfare Surrogates
Bacillus anthracis (Anthrax) is a vey hardy spore forming pathogenic bacteria and is considered a bio-warfare threat agent. Surrogate testing with Bacillus globigii spores is available to increase range of claims to biological warfare threat agents.
Molds
Aspergillus niger Spores
Mold Spores
Challenge testing can be performed using mold spores. Molds such as A. niger (known as black mold) are a common indoor air quality problem. High challenge aerosol concentration are achievable using pure species mold spores. Particle size is in the range of 4um.
Pollen
Morning Glory Pollen (Ipomea Purpurea)
Allergens
Allergens such as pollen, mites and pet dander can be tested for effective removal rate of the irritant. This testing is usuually only performed on filtration type devices or devices that electrostatically charge the pass air. Many UV based system are effective due to the generation of electrostatic charged free radicals.
Some of our Other Related Aerosol Services We Offer:
Pharmaceutical Formulation Development
ARE Labs can provide custom pharmaceutical formulation development for optimal respiratory deposition of various API’s. Whether it is a solution, suspension, or dry powder we can help.