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Explore Transcat's Calibration Services

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Instrument and Equipment Validation Services

Autoclave Validation

  • Temperature mapping of Load patterns
  • Use of Biological Indicators to prove biological kill (10^6 spore population)
  • Measurement of Lethality to prove steam penetration (Lethality of 12 minutes or
    up to 18 minutes for superkill)
  • Calibration of pressure gauges and temperature probes are part of each validation

 

Cold Storage Temperature Mapping

  • 24-hour loaded, empty, or AS-Is mapping available
  • Open door and power failure recovery studies
  • Loop calibrations with in line recorders, Building monitoring systems, and
    digital display
  • Use of NIST traceable wireless or standard data acquisition systems for
    all studies
  • Protocols reviewed and approved by the customers before the technician arrives on site for testing

 

Stability Chambers and Warm Storage

  • Capabilities for mapping temperature, humidity, as well as CO2
  • Stability chamber validations consistent with ICH guidelines or customer quality systems
  • 24-hour loaded and empty mapping or AS-Is mapping available
  • Open door and power failure recovery studies
  • Loop calibrations with in line recorders, Building monitoring systems, and digital display
  • Use of NIST traceable wireless or standard data acquisition systems for all studies
  • Protocols reviewed and approved by the customers before the technician arrives on site
    for testing

 

Glassware Washer Validations

  • Perform cross contamination studies using riboflavin/sucrose soilants or a customer
    provided soilant
  • Verify removal of all detergent as well as soilants
  • Triplicate runs of load patterns to prove reproducibility
  • Protocols reviewed and approved by the customers before the technician arrives on site for testing

 

Oven Validations

  • Perform endotoxin reduction studies for depyrogenation ovens
  • Temperature map vacuum ovens under vacuum and perform pressure leak tests
  • 24-hour temperature mapping on laminar flow, convection ovens, and furnaces (up to 1200C) Note: mapping times will vary depending on the temperature range
  • Loop calibrations with in line recorders, Building monitoring systems, and digital display
  • Use of NIST traceable wireless or standard data acquisition systems for all studies
  • Protocols reviewed and approved by the customers before the technician arrives on site for testing

 

Laboratory Equipment Validation

  • Balances – IOQs meeting USP 41 standards
  • Centrifuges – IOQs testing for control, RPM, time, and temperature
  • Osmometers – IOQs measuring Osmolality over full scale and proper controller functionality
  • Spectrophotometers – IOQs for wavelength accuracy, wavelength linearity, photometric linearity, etc. using Holmium oxide, Potassium chloride and other filters
  • Melting Point Apparatus – IOQs for multiple melting point accuracies over full scale range
  • Use of NIST traceable standards for all testing and in many cases, use of 17025 accredited standards
  • Protocols reviewed and approved by the customers before the technician arrives on site for testing

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