SELF-CONTAINED FOR E.O., STEAM AND H2O2 STERILIZATION INCL. PLASMA

Self-contained biological indicators (SCBI’s) are available for monitoring the efficacy of steam, H2O2 and ethylene oxide sterilization processes. SCBI’s contain bacterial spores on a paper carrier (or Tyvek disc for H2O2/plasma) plus a sealed glass ampoule within a vented plastic vial. The glass ampoule contains a proprietary formulation of soybean casein digest culture media with a pH indicator. The pH indicator remains purple when there is no spore growth and yellow when there is spore growth. This allows quick visual determination of sterilization failures (yellow colour).

The SCBI is easy to use and does not require a strip transfer step that is required in traditional paper strip biological indicators. SCBI’s should be placed inside products or packages undergoing sterilization. Following sterilization, the indicators are removed from the sterilizer and allowed to cool. After cooling the indicator is activated by fracturing the glass ampoule with a crushing device. This allows the contents of the ampoule to come into contact with the spore carrier. The indicator is then placed in the proper incubator (60°C for steam and H2O2) or (37°C for ethylene oxide). Results are available in 24 hours for steam and H2O2 indicators and 48 hours for ethylene indicators. If the indicator remains purple this indicates successful sterilization. Yellow indicators mean a sterilization failure.

 

BIOLOGICAL INDICATORS / SPORE AMPOULES

Etigam Spore Ampoules are ideal for use in validation and routine monitoring of liquid steam sterilization cycles. Spore Ampoules are manufactured using hermetically sealed Type I borosilicate glass containing an exclusively formulated Tryptic Soy Broth (TSB) modified with pH indicator, and Geobacillus stearothermophilus spores. No activation is required; simply expose Spore Ampoules to sterilization process and incubate.

  • Reduced incubation time of 48 hours
  • Clear visible results as growth is evident by turbidity and/or a colour shift of the media from Purple to Yellow
  • Saves time by eliminating aseptic culturing required with traditional spore strips
  • Unique packaging insert keeps Ampoules in upright position and allows for quick reference to the number of units remaining  
  • Each shipment is accompanied by a Certificate of Analysis and Instructions for Use
  • Storage under refrigerated conditions (2°C to 8°C) is required. Do not freeze Spore Ampoules
  • Compliant with ISO 11138-1 and 11138-3
  • Spore ampoules are labelled for industrial use only

 

SPORE STRIPS & SUSPENSIONS

NSS spore strips are traditional biological indicators used to monitor steam, ethylene oxide, dry heat and radiation sterilization processes. They contain bacterial spores on a paper carrier strip within a peel open glassine envelope.

To use a NSS strip, place the indicator within a product or package. The indicator should be placed in the area(s) known to be the most difficult for the sterilizing agent to penetrate. The product containing the indicator is placed within the sterilizer and processed. Following sterilization, the product is removed from the sterilizer and the indicator is removed from the product. The indicator is peeled open and the paper carrier strip removed using aseptic technique and placed in soybean casein digest media. The indicator must be incubated at the appropriate temperature for the indicator type for 7 days. Turbidity within the media indicates sterilization failure.

NSU spores’ suspensions are used to inoculate products undergoing sterilization. They are available for use in steam, ethylene oxide, dry heat and radiation sterilization processes. Spore suspensions are provided with population and resistance values to the sterilization process.

Each vial contains 10 ml of spore suspension in 20% ethanol.