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  • Medical Device Link .
    for routine release. However, parametric release is not commonplace with EtO sterilization processes, and most routine release testing is performed with commercially available BIs. In addition, commercial BIs are used to establish microbial-lethality relationships in nearly all EtO process validations
  • 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 .
    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
  • GSK, Pall Speed Microbiological Contamination Detection
    the user the opportunity to adopt the technology in a broad range of applications, including pharmaceutical product release, monitoring pharmaceutical water systems, environmental contamination monitoring, testing biological indicators used e.g. for autoclave validation and qualifying microbial
  • Medical Device Link .
    and design while others hardly changed at all. Sterilization technologies, having remained unchanged in the physics and chemistry of microbial inactivation, have undergone a different sort of metamorphosis than the medical products they support. In 1980, the primary methods for medical device sterilization
  • Medical Device Link .
    indicators such as Bacillus atrophaeus (formerly B. subtilis var. niger) spore preparations. Sterility is generally defined as freedom from viable microorganisms. However, to expect absolute freedom from these entities is unrealistic. Regardless of the method used for killing a microbial population

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