ADVENTITOUS AGENTS
The presence of mycoplasma or the presence of viruses in products of animal origin are detected.
ANTIVIRAL
A virus stock culture collection containing a variety of DNA and RNA viruses is employed in EPA disinfectant assays, and other procedures. End points for detection are expressed as TCID50, Plaque Forming Units, Hemaglutination, Hemadsorption or Immunofluorescence.
CHEMICAL GERMICIDES
Disinfectants, Sporicides, and Sanitizers as per EPA and European Methods.
COSMETICS
The presence of viruses and their eradication can be studied.
HAND SANITIZERS
Gels, towelettes and other topical products are tested against bacteria and viruses (including Hepatitis A, E coli, resistant staphylococci , Noro Virus, Influenza, Polio etc.) in log reduction time kill experiments. Formulation categories as outlined by WHO (World Heath Organization) seeking at least 15-second in-vitro kills are studied in research screens and predicate testing.
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INTERFERON
The Vesicular Stomatitus Virus (VSV) procedure is conducted in a cell culture plaque reduction assay.
MEDICAL DEVICES
Invasive orthopedic devices and Human Cell and Tissue Products containing anti-microbial agents, topical medicated devices and AATB tissue products are among the articles studied at Gibraltar by Zone of Inhibition and/or Log -Reduction Kill-Time tests.
SCREENING TESTS
Minimum Inhibition Concentration (MIC) assays on pure substances or formulations are performed as well as Kill-Time and Zone of Inhibition tests against a large array of gram positive and gram negative bacteria, yeasts and molds. End points are also expressed as D-values, if required.
WOUND CARE PRODUCTS
Standard agar diffusion and/or killing time tests and ASTM methods are conducted with or without the presence of simulated body fluids against gram positive and gram negative pathogens, including antibiotic resistant strains (MRSA, VRE, multiple drug resistant - MDR). Comparative assays with marketed predicate formulations, (semi-solid, liquid or hydrocolloid) enable a client to prepare for FDA submissions.
Note: ASTM, FDA, Standard, Client, In-House or Published Methods are used, employing ATTC strains or clinical isolates. GLP Protocols as required. Supporting Gibraltar publications are available upon request. |