Self-contained Biological Indicator for the Sterilisation Process

Self-contained Biological Indicators

Self-contained Biological Indicator

Bionova® provides Biological indicators available for use with the IC1020FRLCD incubator. The Biological Indicators provide quantifiable results for plasma sterilisers, steam sterilisers and other decontamination technologies. Results are provided rapidly within 30 minutes, with fully compliant record keeping according to HTM0101-2016. Bionova® biological indicators and Incubator offer a revolutionary approach for the control of the sterilisation process in the Healthcare sector. They provide a clear result of the biological status of the self-contained indicator with full quantitative results.

Moreover, the system provides full traceability compliant with HTM01-01 2016 via its software and communicates directly with a PC for full data storage (optional wifi connection is also available). The Indicator systems utilise fluorescence technology to enable accurate results to be obtained.

Incubators

 

Control and Traceability of the Steam & Plasma Sterilisation Process

 

Steam sterilisation

Sterilisation is the total destruction of all microorganisms, whether or not pathogenic, and their spores. Moist heat in the form of saturated steam under pressure is the oldest and most widely used method of sterilization. It is the most common method of sterilization in the pharmaceutical and medical device industry, because it has a very predictable and reproducible effect on the destruction of bacteria. The parameters of sterilization are time and temperature that can be easily controlled and monitored once the cycle has been validated. Steam sterilization is applicable to sterilize heat and moisture resistant items.
A wide range of factors can reduce the effectiveness of the sterilization process, so regular monitoring of sterilization cycles is necessary to detect inadequate process conditions caused by human error or equipment malfunction. Chemical indicators are one of the most commonly used sterilization monitors as well as a marker of sterilization exposure.

 

Vaporized Hydrogen Peroxide sterilization

 

Sterilization by Plasma or Vaporized Hydrogen Peroxide is a low temperature process based on the biocidal activity of the Hydrogen Peroxide in plasma phase. Being a process below 60 °C and low humidity, is an alternative to Ethylene Oxide sterilization to treat thermolabile materials in short periods.
It is widely used in the sterilization of medical products that have a high temperature sensitive structure or packaging, electrical motors, batteries, endoscopes and surgical instruments in general.

Advantages

  • Reduced release times (about one hour), which leads to a reduction of stocks of
    high cost materials to be reused.
  • Leaves no toxic waste.
  • It turns into water and oxygen at the end of the process.
  • The material does not require aeration.
  • All VH2O2 sterilization control products are manufactured according to ISO 11140-1 standard and under the Quality Management Systems ISO 13485 and ISO 9001 standards.

 

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