ISO 17025 ACCREDITED BIOFILM TESTING
INCLUDING GLP COMPLIANT ASTM E2871
& SINGLE TUBE METHOD
ISO 17025 accredited Biofilm Testing, we are leading the market with accredited biofilm methods – GLP Compliant Testing.
We offer a variety of biofilm testing methods, such as the Single Tube Method, the Drip Flow Biofilm Reactor, the CDC Biofilm Reactor and the Minimum Biofilm Eradication Concentration (MBEC). Microorganisms such as bacteria, fungi and yeast can exist as free floating planktonic entities or they can attach to a surface (or one another) to form a microbial biofilm. In nature, 80% of bacteria exist within a biofilm. When microorganisms live beneath a biofilm, they are significantly less susceptible to antimicrobial agents (and the host’s immune system).
Standard microbiological testing, however, focuses almost exclusively on planktonic bacteria. As such, current standard testing may underestimate the quantity of active agent required to effectively remove a microbial biofilm.
How can our biofilm testing expertise support your project?
Perfectus Biomed will work with you to help you understand the benefits of different biofilm testing models. We will then choose a test method that is most suitable for your product, using either ISO 17025 accredited biofilm models or adapting/designing a biofilm model that suits your requirement.
GLP compliant testing is also available.
examples of ISO 17025 accredited methods:
Minimum Biofilm Eradication Concentration (MBEC)
The Minimum Biofilm Eradication Concentration (MBEC) assay is a high throughput screening model. The MBEC assay evaluates biofilm grown under batch conditions (no flow of nutrients into or out of an individual well). The model can be used to determine the efficacy of multiple antimicrobial products simultaneously at multiple concentrations against pre-formed biofilms.
SOP 536: Standard test method for testing disinfectant efficacy against Pseudomonas aeruginosa and Staphylococcus aureus biofilms using the Minimum Biofilm Eradication Concentration (MBEC) assay modified from ASTM E2799 standard method.
CDC Biofilm Reactor
The CDC Biofilm Reactor model develops reproducible biofilms on 24 individual coupon surfaces under flow. The coupon materials used in the model are interchangeable and can be chosen to help simulate the use of a product. Examples include polycarbonate, copper, ceramic, stainless steel and glass. The reactor can be tested in a batch system or can include addition of fresh nutrients during incubation to simulate real-world environments in which biofilms develop.
SOP 537/555: Quantification of biofilm growth with low shear using the CDC biofilm reactor (Pseudomonas aeruginosa and Staphylococcus aureus and Candida albicans) modified from ASTM E2562 standard method.
Drip Flow Biofilm Reactor
The Drip Flow Biofilm Reactor is used to reproduce biofilms on glass coupons under defined conditions suitable for efficacy testing. The biofilms represent generalized situations where biofilm exists at the air/liquid interface with a continuous flow of nutrients under low fluid shear. The Drip Flow Reactor can be used for growing and characterizing multi-species biofilms. Based on the growth requirements of the organism, the method can be optimized by changing the operational parameters.
SOP 538: Standard test method for the quantification of biofilm grown using the Drip Flow biofilm reactor with low shear and continuous flow modified from ASTM E2647 standard method.
The Single Tube Method is used to determined the efficacy of biocides against pre-formed biofilms, testing test water soluble powders or liquid formations on hard or non-porous surfaces in which biofilm can grow. The Single Tube Method is used to obtain biofilm removal claims, which demonstrate a products’ ability to remove biofilms. In order to register an antimicrobial product for a public health biofilm removal claim, the Environmental Protection Agency (EPA) require efficacy data to be submitted under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
SOP 575: Test method for testing disinfectant efficacy against bacterial biofilm grown for 48 hours following the principles of ASTM E2871-19 in the CDC biofilm reactor using the single tube method.
Ex Vivo Porcine Lung Model
Patients with diseases such as cystic fibrosis are more prone to lung infections. The model has been developed so that it replicates these infections as closely as possible in an ex vivo manner, using the mucosal epithelial layer of the bronchiole, and artificial sputum medium to simulate the sticky mucus produced in the lungs. This method can also be used to test topical and aerosolised treatments for infected mucosal wounds in line with ISO 17025 regulations.
SOP 556: Quantification of Biofilm Using an ex vivo Porcine Lung Model
Ex-vivo Burn Wound Model – In approval process
The Ex-vivo Burn Wound Model is used for growing repeatable single-organism Pseudomonas aeruginosa and Staphylococcus aureus biofilms on the surface of individual porcine skin burn wounds. The model can be used to enable the pre-clinical efficacy testing of antimicrobial agents such as antibiotics, and dressings. Similar tests are not currently commercially available to UKAS 17025 standards, for testing pharmaceuticals and dressings against simulated infected burn wounds.
SOP 578: Quantification of Biofilm Using an ex vivo Burn Wound Model
Examples of ISO 9001 METHODS:
- Colony Drip Flow reactor model
- Porcine skin explant drip flow model
- Single and multi-species biofilm assays
- Bacterial and fungal biofilm assays
- Microtitre plate assay
- Flow cell reactor model
- In line ‘Robbin’s Device’ biofilms models – used in industrial biofilm treatments
Models are available using static or continuous flow systems.