It has been estimated that the majority of chronic wounds result from some level of microbial infection. Those that are not clinically infected are almost certainly colonised and therefore can be deemed to be at risk of infection6.
By supporting companies who produce chronic wound care products we aim to help; decrease patient pain, decrease the number of amputations resulting from long term chronic wounds and increase patient quality of life.
Perfectus Biomed can help support with regulatory submissions, your company research and development and assist you in demonstrating the USP of commercially available products.
We also offer a range of standard test methodologies including:
- AATCC Test Method 100: Antibacterial Finishes on Textile Materials.
- Modified AATCC Test Method 100
- AATCC Test Method 147 Antibacterial Activity Assessment of Textile Materials: Parallel Streak Method.BS EN ISO 11737-1: Sterilisation of Medical devices. Microbiological Methods. Determination of a population of microorganisms on products (Bioburden).
- BS EN 13726-1: Test methods for primary wound dressings. Aspects of absorbency: Free swell absorption, fluid retention and absorption under a fixed load.
- BS EN 13726-2: Test methods for primary wound dressings. Moisture vapour transmission rate (MVTR) of permeable film dressings. Section 3.2: Moisture Vapour Transmission Rate – In contact with vapour.
- BS EN 13726-2: Test methods for primary wound dressings. Moisture vapour transmission rate of permeable film dressings. Section 3.3: Moisture Vapour Transmission Rate – In contact with liquid.
- BS EN 13726-3: Test methods for primary wound dressings. Waterproofness.
- BS EN 13726-4: Test methods for primary wound dressings. Conformability.
- BS EN ISO 20743:Textiles, Determination of antibacterial activity of antibacterial finished products.
- BS EN IS0 20645: Textile fabrics. Determination of antibacterial activity. Agar diffusion plate test.
- ASTM E2149: Standard Test Method for determining the antimicrobial activity of immobilised antimicrobial agents under dynamic contact conditions.
We offer a range of customised test methodologies which include:
- Direct contact dressings testing, a method adapted from Gallant-Behn et al (2005).
- Shake-flask method adapted from upon a method in Parsons et al (2005).
- Bacterial barrier testing.
- Viral/phage barrier testing.
- CDC biofilm reactor model adapted for testing wound dressings based on ASTM E2871 and ASTM E2562.
- Drip flow reactor model adapted for testing wound dressings based on ASTM E2647.
- Porcine skin explant drip flow model based on ASTM E2647.
- Wicking absorbency.
- MMP modulation testing.
- Dressing material strength testing – wet and dry.
- Peel force testing.
More about our wound care testing process
Our testing experience includes working with:
- Wound dressings
- Topical wound agents
- Dressing removal agents
- Wound irrigation solutions
- Plasma devices
- Negative pressure wound therapy devices
We offer support with:
- 510(k) submission
- FDA approval
- Dossier submission
- Grant applications
Our library of test organism includes…
Choose from our library of test organism including standard reference strains, clinical isolates and environmental isolates.
Single or mixed species assays containing:
Acinetobacter baumannii, Actinomyces naeslundii, Adenovirus (human), Aspergillus brasiliensis, Aspergillums niger, Aureobasidium pullulans, Bacillus cereus, Bacillus subtilis, Camplylobacter jejuni, Candida albicans, Clostridium difficile, Corynebacterium minutissimum, Enterobacter cloacae, Enterococcus faecalis, Enterococcus faecium (VRE), Enterococcus hirae, Escherichia coli, Fusobacterium nucleatum, Haemophilus influenzae, Heliocbacter pylori, Halomonas magadiensis, Klebsiella pneumoniae, Lactobacillus casei, MRSA, Neisseria gonorrhoeae, Neisseria subflava, Porphyromonas ginigvalis, Prevotella nigrescens, Propionibacterium acnes, Proteus mirabilis, Pseudomonas aeruginosa, Salmonella enteritidis, Shigella dysenteriae, Staphylococcus aureus (MRSA and MSSA), Staphylococcus epidermidis, Staphylococcus haemolyticus, Stenotrophomonas maltophilia, Streptococcus mutans, Streptococcus oralis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus zooepidemicus, Tannerella forsythia, Trichophyton rubrum, Veillonella dispar. WHO Priority organisms. Other- please ask.
- Christmas Opening Hours
- Regulatory Focus; Medical Device Regulations
- World Health Organisation publishes list of bacteria for which new antibiotics are needed
- Perfectus Biomed shortlisted for the Mornflake Oats Award for Innovation and the Outstanding Cheshire & Warrington Business Leader Award
- FDA to improve the review of shared Risk Evaluation and Mitigation Strategies to enhance generic drug access
- The National Biofilms Innovation Centre (NBIC) Launch Event
- Perfectus Biomed Website Redesign
- EPA protects health care facilities from unregistered antimicrobial pesticides
- Living Wage Week
- Pharmig’s 25th Celebratory Conference 2017