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  • Medical Device Link .
    is determined by a complex function of time, temperature, humidity, light, oxygen, and vibration, proper packaging can control many of these variables. For example, light- and humidity-resistant foil packages can minimize the effects of humidity and light. Such packages
  • Aseptic Processing, the Japanese Way
    are equipped with dehumidification units to reach the relatively low humidity levels required by the Steris vapor phase hydrogen peroxide generators prior to the decontamination process. Decontamination of the isolators was validated using biological indicators on stainless steel coupons with a population
  • Medical Device Link .
    for residuals, its effects are difficult to express mathematically because the rate of microbial lethality is affected by three primary process parameters: EtO concentration, temperature, and relative humidity (RH). Methods of integrating the effects of these factors were lacking until recently, when one
  • 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
  • PAT: The Value of Better Control
    impacted. In the dryer example above, where ambient humidity is measured, the heater can be adjusted as a weather front moves in and moistens the drying air. The powder moisture is held fairly constant. Finally, MPC has enabled direct control of the process objectives: quality, throughput and efficiency
  • Hot or cold interiors? Software assures they're just right
    ) to calculate local thermal comfort as a function of air temperature, surrounding surface temperatures, air velocity, humidity, direct solar heating, as well as the activity level and clothing of each individual. The model takes climactic conditions in which the vehicle is operating to develop

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