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  • Medical Device Link .
    are monitored with chemical and biological indicators within the instrument load. A biological indicator (BI) is "a device consisting of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. " After sterilization, the BIs
  • Medical Device Link .
    and maintenance of steady-state conditions, this article focuses only on the three primary parameters. The effects of these factors were studied at the researchers' laboratories using biological indicator evaluator resistometer (BIER) vessels. Designed for the calibration of biological indicators
  • Medical Device Link .
    Estimating the Effects of EtO BIER-Vessel Operating Precision on D-Value Calculations D-values for several ranges of expected BIER-vessel performance have been calculated and compared with a common BI-certificate value. Commercially available biological indicators (BIs) are of critical importance
  • Medical Device Link .
    processing cycle consists of three steps: preconditioning, sterilization, and aeration. Prior to sterilization, biological indicators (BIs) are placed in the product load, which is
  • Medical Device Link .
    Sterilization Methods Stand the Test of Time The development of biological indicators and parametric release has led to improvements in sterilization processes and shifts in industry preferences. Karl J. Hemmerich, John Masefield, and Jerry R. Nelson Over the past 25 years, the medical device
  • Medical Device Link .
    Medical Device & Diagnostic Industry Deliberate decision making during the structuring of microbial challenges, product loads, and biological indicators can provide a validation process for EtO sterilization that ensures accuracy, the absence of microbes, and a smooth testing procedure. A companion
  • Medical Device Link .
    , the concept of accumulated lethality the time of exposure to a lethal agent required to cause a selected reduction in the survivorship of a biological indicator (BI) population has proven very useful. The availability of models describing survivorship when moist heat is the lethal agent has enabled
  • Medical Device Link .
    control of temperature, humidity, vacuum and positive pressure, and gas concentration. It is estimated that 45% of medical devices manufactured in the United States are sterilized using EtO gas. The validation process for EtO sterilization involves the use of product inoculated with biological
  • Medical Device Link .
    or better while devices that will come in contact with blood or compromised tissues must have an SAL of 10 For a product lot to be declared sterile and released to market following routine ethylene oxide (EtO) sterilization, the biological indicators (BIs) that are placed within the lot prior