SCAS  Sumika Chemical Analysis Service, Ltd.

Evaluation of Medical Devices and Materials

Medical devices and materials must have superior properties in the areas of efficacy and safety. In particular, when they come into contact with blood or with tissue fluid, it is important for them to have superior biocompatible interface characteristics.
Sumika Chemical Analysis Service, Ltd. supports R&D in medical devices and materials with a combination of accumulated academic knowledge and analytical techniques over many years in chemical and pharmaceutical fields. We also develop a strategy and provide consultation on the various tests and approaches required for approval or certification

  Examples of subjects;
    Catheters, tubes, stents, dialysis materials, hollow fiber membranes, contact lenses, intraocular lenses, artificial organs, transfusion bags, injectors and syringes, needles, medical packaging materials, dentistry materials, artificial bone materials, percutaneous absorbefacients, endoscopes, biosensors, etc.

  • Medical Devices and Materials Evaluation
  • Products and Materials Evaluation
    • Ophthalmological materials (contact lenses, intraocular lenses, etc.)
    • Dental materials (natural teeth, false teeth, composite resins, adhesives, etc.)
    • Biosensors (glucose sensors, etc.)

  Evaluation of Medical Devices and Materials

 
  • State of surface reformulation in cell culturing sheets (XPS)
  • Surface wettability of materials(contact angle)
  • Surface status of monomolecular film (PAR-XPS)
  • Leachable materials test

Testing items Analytical Method Details
Wettability Contact angle Hydrophilicity and hydrophobicity of the material surface are measured.
Charge state Zeta potential Elecatrical charge characteristics are identified.
Micro structures Scanning Electron Microscope (SEM),
Transmission Electron Microscope (TEM),
Atomic Force Microscope (AFM)
Micro structures such as surface irregularities and orientation can be observed.
Pore distribution,
melting temperature of pore water
Gas adsorption method, Mercury intrusion technique,
Differential Scanning Calorimetry (DSC)
Materials for which performance is largely controlled by pore diameter, such as dialysis materials, are measured.
Surface chemical structures Fourier Transform Infrared Spectrophotometry (FT-IR),
X-ray Photoelectron Spectrometry (XPS),
Time-of-Flight Secondary Ion Mass Spectrometry (TOF-SIMS)
The chemical structures of the material surface are identified.
Surface treatment and modification status FT-IR, XPS, TOF-SIMS Surface states that have been treated with coatings or modifications can be evaluated.
Hydration structures DSC Hydration structures on material interfaces in moist states can be identified by the presence of free water, intermediate water, and unfreezable water.
Microbial testing Viable bacteria count tests, Microbial limit tests, Sterilization tests, Endotoxin tests (compliant with the Japanese Pharmacopoeia) Viable bacteria counts (bacteria, fungi), specific microorganisms (coli bacilli, salmonella, pseudomonad aeruginosa, staphylococcus aureus), and endotoxin assessment are available for material surfaces.
Biological safety Cytotoxicity screening Initial screening of candidate materials can be provided.
Protein adsorption quantities Absorption photometry (Lowry method)
Surface Plasmon Resonance (SPR)
The adsorption quantities of proteins into the material surface are measured.
Materials evaluation before and after sterilization treatment FT-IR, XPS, Chemiluminescence The impact on materials of sterilization treatments using γ rays, electron beams, heat, and chemical fluids can be evaluated.
Gas permeability Gas and steam diffuse transmission testing,
Atmospheric Pressure Ionization Mass Spectroscopy (API-MS)
The permeability rates of various gases can be evaluated under differing temperature conditions.
Monomer type FT-IR, Pyrolytic-GC/MS The monomer type of the material is identified.
Additive quantities Gas Chromatography (GC),
Liquid Chromatography (LC)
Additives included in the material can be qualitatively examined and subjected to standard tests for additive elution quantities.
Mechanical strength Fatigue tests, Rupture strength, Elasticity, etc. Material strengths, corresponding to JIS standard tests, can be tested with reference to usage conditions.

  Evaluation of Products and Materials
    We focus our efforts on analytical evaluation technologies that examine the specific functionality of products and materials. The following are representative examples.

  Ophthalmological materials (contact lenses, intraocular lenses, etc.)
 
  • Observation of pigments distribution in color contact lenses (cross section)
  • Observation of edge shape on contact lenses (cross section)
  • Tensile test (physical characteristics and mechanical testing) on soft contact lenses
  • Other tests for soft contact lenses required for approval

Testing items Details
Composition and structure analysis Monomer type, additives, pigments, plasticizers, impurities, elution test, detergent residues, etc.
Morphology observation and surface analysis Wet state, surface roughness, cross section, sandwich structure (three- layer structure), pigments distribution (pigments intensionality), edge shape, other non-destructive observation, surface accretion, etc.
Reliability assessment Accelerated deterioration test, light aging test, etc.
Physicochemical characteristics Water absorption, water retentivity, wettability and water repellency, sorbability, diameter, thickness, vertex power, luminous transmittance, strength, refractive index, prism error, water content, extractable, disinfectant compatibility, oxygen permeability coefficient, etc.
Biological safety Cytotoxicity, sensitization, irritation/intracutaneous reactivity, genotoxicity, ocular study using rabbit eyes, etc.

  Dental materials (natural teeth, false teeth, composite resins, adhesives, etc.)

Testing items Details Applied methods and equipment
Composition and structure analysis Monomer type, additives, plasticizer, qualitative/quantitative impurities, crystalline structure analysis, etc. Pyrolysis/ Gas Chromatograph Mass Spectrometry analysis (Py/GC-MS), Fourier Transform Infrared Spectrophotometry analysis (FT-IR), Inductively-Coupled Plasma Emission Spectrometry (ICP-AES), Inductively-Coupled Plasma Mass Spectrometry (ICP-MS), Ion Chromatography (IC), X-ray Diffraction (XRD)
Molphological observation and surface analysis Nano-level observation, surface roughness measurement, cross section observation, qualitative surface accretion, non-destructive 3D observation, etc. Transmission Electron Microscope (TEM), Scanning Electron Microscope (SEM), Atomic Force Microscope (AFM), X-ray Computer Tomography (X-ray CT), FT-IR, X-ray Photoelectron Spectrometry (XPS), Time-of -Flight Secondary Ion Mass Spectrometry (TOF-SIMS)
Reliability assessment Accelerated deterioration test, etc. Thermohygrostat bath
Physical characteristics Hardness, tensile test, compression test, viscoelasticity, etc. Hardness gauge, mechanical strength tester, Dynamic Viscoelasticity (DMA)
Chemical characteristics Wettability, water absorption, corrosion resistance, solubility, leachable materials, dirt adhesion, etc. Contact angle, ICP-AES, ICP-MS, IC, XPS, TOF-SIMS
Biological safety Cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity, genotoxicity, implantation, simulation use testing -
UV curing resin behavior under UV irradiation Analysis of gases emitted on UV irradiation, structural change investigation, etc. Gas Chromatography (GC) UV irradiation Pyrolysis Gas Chromatograph Mass Spectrometry (UV/Py/GC-MS), FT-IR

  Biosensors (Glucose sensors, etc.)
 
  • Glucose sensor

Testing items Details Applied methods and equipment
Morphological observation Observation of surfaces and cross sections of reagent layers, electrodes, etc.
Non-destructive observation of specimen introduction space
Non-destructive observation after packaging, etc.
Optical Microscope,
Scanning Electron Microscope (SEM),
Atomic Force Microscope (AFM),
X-ray Computer Tomography (X-ray CT)
Surface analysis Analysis of surfaces states of reagent layers, electrodes, etc.
Structural analysis of reagent layers
Adsorption characteristics of electrode surfaces, etc.
Fourier Transform Infrared Spectrophotometry analysis (FT-IR), X-ray Photoelectron Spectrometry (XPS), Time-of-Flight Secondary Ion Mass Spectrometry (TOF-SIMS), Raman Spectroscopy, EPMA, Surface Plasmon Resonance (SPR)
Physical property testing Substrate strength flexibility testing,
Electrode adhesion strength, etc.
Bending and tensile strength test, Hardness test, Compression test, Impact test, Scratching test
Preservation stability (testing) Steam and gas permeability, Accelerated tests (temperature and humidity, gas corrosion, etc.),
Gas inclusion evaluation,
Non-destructive observation, etc.
Atmospheric Pressure Ionization Mass Spectrometry (API-MS), Gas Permeation tester, Thermohygrostat , Gaseous corrosion tester, Gas Chromatography (GC), Gas Chromatograph Mass Spectrometry (GC-MS), X-ray CT
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