Product Description
Self-Contained Biological Indicators (SCBIs) for monitoring Steam processes consist of:
A polycarbonate vial and cap
A crushable media ampule which contains modified Trypticase® Soy Broth (TSB) with a pH indicator. The
modified TSB will transition from the initial purple color to yellow and/or demonstrate turbidity in the presence
of bacterial growth
An inoculated carrier (disc) of Geobacillus stearothermophilus (Cell Line 7953) with a population level of 105
(SCS-05) or 106 (SCS-06)
Intended Use
The SCBIs may be utilized to monitor Steam sterilization process efficacy. The SCBIs are labeled For Industrial Use Only.
Instructions for Use
Exposure: SCBIs may be placed inside representative materials or within the chamber directly. Package or wrap
product as usual, if applicable. Locate SCBIs or product in areas most difficult to sterilize, as outlined in your
specific sterilization validation protocol (usually four corners front, four corners rear, center-center and center-top)
or according to standard operating procedure. Run the cycle.
After sterilization or exposure, remove SCBIs or product from sterilizer.
Activation: Press the white cap of the unit down until the glass media ampule contained within the vial is crushed.
Ensure that the disc is immersed in the growth medium. Activate one SCBI which has not been exposed in a sterilization process as a Positive Control.
Incubation: Place the processed, activated SCBIs and the Positive Control in a vertical position in an incubator at 55°C to 65°C for a minimum of 24 hours
Monitoring: Examine the SCBIs and record observations. All positive SCBIs should be disposed of immediately.
Do not continue to incubate a positive SCBI. Continued growth may result in metabolism of amino acids in the absence of sugars, causing the pH to rise and result in color reversion that is visibly darker than a sterile unit.
These should be considered as positive for growth (turbidity will be present).
For unexpected positives, it is recommended that a Gram stain be performed. Gram positive rods are characteristic of the indicator organism.
Interpretation: Control SCBI: The Positive Control SCBI should exhibit a color change to yellow and/or demonstrate turbidity. If the Positive Control does not show signs of growth, consider the test invalid.
Test SCBI: A passing sterilization cycle is indicated by no signs of turbidity and the purple color not transitioning to yellow. A failed sterilization cycle is indicated by turbidity and/or a color change to yellow.
Chemical Indicator (CI): The chemical indicating strip (along the bottom of the SCBI label) should transition from yellow to dark when exposed to a Steam process. Lack of color change or a partial change in color of the CI does not necessarily indicate failure. The CI does not prove efficacy of sterilization; the biological result should be used
to gauge efficacy of the sterilization cycle.
Physical Properties
Process Steam
Dimensions 13 mm x 61 mm
Packaging 50/Box
Chemical Indicator Each SCBI contains a CI strip on the vial label. The CI should transition from
yellow to dark when exposed to a steam process.
Monitoring Frequency
For greatest control of sterilized goods, it is recommended that one or more SCBIs be included with every load.
Performance Characteristics
Population 1.0 to 5.0 x 106 per disc (Crosstex Code SCS-06)
Purity No evidence of contamination present in sufficient numbers to adversely affect the
finished product.
Steam Resistance
D value at 121°C ± 0.5°C
1.5 to 3.0 minutes
The Steam D value range is based on the requirements outlined in the USP, ISO
11138-3 and guidance issued by the Food & Drug Administration (FDA).
Survival – Kill Times
Calculated based on the formulas outlined in the USP, ISO 11138-1 and guidance
issued by the FDA.
z value
≥6°C
The z value is based on D values at three temperatures in the range of 110°C to
130°C. Crosstex typically utilizes D values determined at 118°C, 121°C and
126°C.
Post-Market Criteria
Population: 50% to 300% of certified population
D value: ± 20% of the certified D value
Survival Time: All SCBIs result in growth at the certified survival time
Kill Time: All SCBIs result in no growth at the certified kill time
Disposal
Autoclave for not less than 30 minutes at 121ºC or per other validated disposal cycle prior to discard.
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| Brand | Pyrex |