The Challenge Test Pack simulates a condition that makes steam penetration into an autoclave more difficult; the PCD was designed based on the standard reference device specified by Brazilian regulations. It contains a Type V integrating chemical indicator, making it ideal for load release. It may also include a biological indicator (BI)—specifically, two indicators: one for testing and one for control. It includes an adhesive record sheet ideal for archiving results and is compatible with any type of autoclave.
Indicators with 24-hour and 48-hour readout times are ideal for implantable loads. Indicators with 1-hour or 3-hour readout times may be used for emergency load release; however, simultaneous monitoring with 24-hour and 48-hour indicators is recommended. The PCD can be customized with different types of biological indicators upon request.
Designed to monitor steam sterilization in gravity and pre-vacuum sterilizers, this simulates a condition where steam penetration is most difficult. Place the sealed package near the autoclave door or the drain. If using a Process Challenge Device (PCD) that contains a control biological indicator (BI), remove the indicator before sterilization and then run the sterilization cycle.
Allow the package to cool, then open it and locate the Type V indicator and the biological indicator (if present). Incubate the BIs and record the result of the chemical indicator (CI); the CI can be affixed to the response sheet.
The chemical indicator is considered to have passed if the color changes from pink to gray following the sterilization process. The sterilization cycle is 4 minutes at 134°C or 17 minutes at 121°C. Biological indicators (BIs) must be incubated according to their type: rapid-readout indicators in fluorescence incubators, and—following the initial rapid fluorescence result—in standard heating incubators, where they must not show a yellow color after 24 hours (confirming the negative fluorescence result). Standard 24-hour and 48-hour BIs must be incubated in heating incubators; they should not change color after this period, indicating the absence of viable cultures.
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