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Product Description 1 mL Spore Ampules are Self-Contained Biological Indicators for monitoring Steam processes consisting of a hermetically sealed glass ampule which contains modified Trypticase® Soy Broth (TSB) with a pH indicator and Geobacillus stearothermophilus (Cell Line 7953) with a population level of 104, 105 or 106. The modified TSB will transition from the initial purple color to yellow and/or demonstrate turbidity in the presence of bacterial growth.
Intended Use The Spore Ampules may be utilized to monitor Steam sterilization efficacy. The Spore Ampules are ideal for monitoring liquid steam sterilization cycles but may also be utilized in monitoring dry loads. Spore Ampules are labeled For Industrial Use Only.
Instructions for Use Exposure: Spore Ampules may be placed inside representative materials (containers of liquid) or within the chamber directly. Package or wrap product as usual, if applicable. Locate product or Spore Ampules in most difficult location to sterilize, as outlined in your specific sterilization validation protocol or according to standard operating procedure. Run the cycle. After sterilization or exposure, remove Spore Ampules or product from sterilizer. Allow product or Spore Ampules to cool to the touch. No activation is required. Handle Spore Ampules with care as contents are extremely hot. Leaving the Spore Ampules in the sterilizer post-exposure may have a negative impact on the product’s performance. As such, Spore Ampules left in the chamber for extended periods of time (>24 hours) post-exposure should be discarded.
Controls: A Negative Control ampule, Crosstex Code SA1-NC-10, may be used in conjunction with the Spore Ampules, where a negative control is required. If a Positive Control is needed, label one unprocessed Spore Ampule as “Positive Control”.
Incubation: Place the processed Spore Ampules, the Negative Control and the Positive Control in a vertical position in an incubator at 59°C to 63°C for a minimum of 48 hours.
Monitoring: Examine the Spore Ampules daily during incubation. Record observations. All positive Spore Ampules should be disposed of immediately.
For unexpected positives, it is recommended that a Gram stain be performed. Gram positive rods are characteristic of the indicator organism.
Interpretation: Negative Control (Crosstex Code SA1-NC-10): The Negative Control Ampule should not exhibit a color change to yellow and/or demonstrate turbidity. Utilize the Negative Control as a color comparison for the exposed Spore Ampules, where applicable.
Positive Control Spore Ampule: The Positive Control Spore Ampule should exhibit a color change to yellow and/or demonstrate turbidity. Utilize the Positive Control as a color comparison for the exposed Spore Ampules, where applicable. If the positive control does not demonstrate a yellow color and/or turbidity, the results for test Spore
Ampules should not be considered valid. Verify incubation conditions were met.
Test Spore Ampules: A passing sterilization cycle is indicated by a test Spore Ampule which retains its original purple color and is free from turbidity. A failed sterilization cycle is indicated by turbidity and/or a color change to yellow.
Physical Properties
Process Steam
Dimensions Approximately 58 mm x 10.8 mm
Packaging 15 or 50 per box depending on the product code
Volume 1 mL
Performance Characteristics
Population 1.0 to 5.0 x 10x per ampule, where x is the population level of the Spore Ampule
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 Spore Ampules result in growth at the certified survival time
Kill Time: All Spore Ampules result in no growth at the certified kill time
Disposal
Autoclave for not less than 30 minutes at 121°C or per validated disposal cycle prior to discard
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| Brand | Pyrex |