Laboratory Completed

GxP, 21CFR Part 11 (ERES), training, audits, safety, QC/QA, validations

 

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LABORATORY
McGaw | B.Braun, Allergan, and Qualisys

  • Chemistry
    • Infra Red Spectrum analysis - Perkins Elmer (Liquid and Solid)
    • Gas Chromotography - Hewlette Packard 6890 II
    • Standards and Sample testing
    • Obtaining results within a minimum of 99% correlation of obtained Linear Regression
    • Maintenance of machine, peripherals, computer, printer, gas delivery, headspace, gas tanks
      • Troubleshooting
      • Spectrophotometer (UV and visible)
      • pH analysis (Electronic and Titration method)
      • Atomic Absorption analysis
      • FPLC (Pharmacia) / HPLC (familiarity)
      • Fractionating (Pharmacia)
      • IMx (Abbott) Spectrophotometry (familiarity)
      • Immunoassay techniques / Enzyme reactions (manual / robotics - Tecan / Autolucy Anthos Rosys)
      • EIA and use of software to characterize enzyme activity
      • Luminescence (Zylux Luminometer system)
  • Biological
    • Biochemical
      • Electrophoresis
      • Western Blotting
      • Immunoblotting
    • Microbial
      • Limulase Amebocyte Lysate (clot) testing of surgical devices
      • Auxonographic testing of Antibiotic affectivity
      • Bioburden testing of air water, plastics, surgical devices, and solutions
      • Filtration and incubated growth on TSA plate
      • Heat Shock
      • Inoculating & Enumeration
      • General biochemical ID techniques
      • Gram Staining, acid-fast stain, OF-Glucose, Oxidase, Catalase, etc.
      • Surface testing (RODAC and Swab)
      • Sterilizer use - Castle / Amsco
    • Environmental Monitoring
      • Particulate Matter monitoring in water and air using HIAC or MetOne
      • Velocity of air using AIRVELO
      • Pressure, temperature, and humidity monitoring
      • HEPA hood leak testing
  • Data trending
    • LIMS
  • Other / Miscellaneous
    • Instron (basics)
    • Comparitor
    • Oscilloscopes (various)
    • Multimeter (Fluke and other)
    • Microcalipers
    • Tensiometer
    • Fluid / Air flow meters
    • Pressure gauges
    • Filter integrity testers
    • Radiation Dose Meters
    • IR thermometers
    • Thermocouple / RTD, Kaye Validator Digistrip)
  • Metrology
    • Micropipettetors and Repeaters (2000 L to 0.5 L) – (3 to 5 point standards)
    • Scales and balances (0.1 g to 300kg)
    • Thermometers / Thermocouples
    • Pressure gauges
    • pH meters
    • Beakers / Volumetric cylinders / Graduated cylinders
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