Laboratory Test Request

Silver Collagen Wound Dressing Silver Characterization Study Testing

Project Description

USA FDA GMP Medical Device Laboratory needed for Silver Collagen Wound Dressing Silver Characterization testing including the following tests:

i. Particle size(s): Field Emission SEM
ii. Particle aspect ratio (s): Field Emission SEM
iii. Surface reactivity: FTX
iv. Oxidation state(s): FTX
v. Number of particles released with respect to time under physiologically relevant conditions
vi. Kinetics of conversion from elemental silver to other silver species such as ionic silver or other silver compounds: you will provide literature
vii. Shape and shape distribution
viii. Aggregation/agglomeration state and distribution (e.g., number density): Field Emission SEM
ix. swelling characteristics: swelling &absorption
x. Your material specifications do not include a range of osmolality. Please provide an osmolality range and conduct swelling experiments with the material at the extremes of your osmolarity range. Please provide a justification for your reported osmolality range. : Osmolarity report
xi. Exhaustive formulation (material and concentration) of the final, finished subject device and Ag NP composition and purity
xii. Silver elution profile from the device: 3 days study on wound fluid of AAS (Atomic Absorption Spectroscopy)
xiii. Ag NP distribution within and on the surface of the subject device: Field Emission SEM
xiv. Nanoparticle surface characteristics (e.g., surface chemistry, surface charge/zeta potential): Zeta sizer on raw material silver
xv. Solubility/dispersibility

Project Information

Number:23-02442

Industry:Medical Devices

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