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Package monitoring indicators

Application
Package monitoring indicators are used inside packs or containers to monitor all relevant parameters of steam sterilization processes. These indicators should only be used if solid and porous goods are sterilized. Package monitoring indicators only provide sterility information at the position inside the chamber where they are located. They should be placed at the most difficult areas to be sterilized inside packs. It is not possible to monitor internal areas of hollow goods, i.e. tubes and/or minimal invasive surgical (MIS) instruments with package indicators as they cannot be placed into hollow lumens.

Different versions:

    1. For steam sterilization processes
    121° C, 16,5 min or 134° C, 3 min or longer sterilization times:

  • − C-S-P-4-SV1: Class 4 package monitoring indicators, adhesive for documentation
  • − C-S-P-5-SV1: Class 5 package monitoring indicators, adhesive for documentation
  • − C-S-P-5-58×35-SV: Class 5 indicators for steam sterilization processes
  • − C-S-P-5-78×48-SA-SV1: Class 5 indicators containing pre-defined sections for manual documentation (tray number, patient name, sterilization and expiry date, signature of person responsible)
  • − C-S-P-6-SV1: Class 6 package monitoring indicator, adhesive for documentation
  • 2. For prion programs in steam sterilization processes 134°C, 18 min:

  • − C-S-P-6-SV2: Class 6 package monitoring indicator adhesive for documentation, especially for prion programs
  • 3. For formaldehyde, ethylene oxide and hydrogen peroxide (H₂O₂)/plasma sterilization processes Package monitoring indicators for different steriliza tion processes for documentation in printers:

  • − C-E-P-4-SV3: Class 4 indicators for ethylene oxide sterilization processes
  • − C-F-P-5-58×35-W-SV4: Class 5 indicators for formaldehyde sterilization processes
  • − C-E-P-5-58×35-W-SV3: Class 5 indicators for ethylene oxide sterilization processes
  • − C-V-P-58×35-W, C-V-P: indicators for hydrogen peroxide (H₂O₂)/plasma sterilization processes After sterilization and release all the above self-adhesive indicators can be transferred into the patient documentation file.

Performance Characteristics

Package monitoring indicators respond to all critical parameters in a steam sterilization process. All steam indicators fulfil the requirements of class 4, 5 or 6 indicators according to the European standard EN ISO 11140-1. Indicators only change its colour to the end point if the sterilization parameters have been achieved. In dry heat sterilization processes all indicators are tested at 140°C, 30 min and do not change its colour to the final end point.

Benefits

  • • Package monitoring indicators for standard and special cycles (e. g. “prion sterilization cycles”).
  • • Monitoring of all critical parameters of the sterilization process at the position the indicators are located.
  • • Environmentally friendly, no unnecessary waste.
  • • Patient-related documentation using self-adhesive properties.
  • • All gke chemical indicator strips are protected from bleeding by a polymer binder and surface coating and can be disposed off with normal garbage.
  • • Professional product design and manufacturing process provides cost-effective indicators.
  • • Easy interpretation of the results due to precise colour change.
  • • The indicator colour chemistry is a non-reversible chemical reaction. The indicators can be documented colour-proof for several years without changing back

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