Self-Contained Spore Ampoules to Monitor Liquid Steam Sterilization, Log 4 spore population, Size: 47mm X 10.6mm x 1ml (volume), 50/box
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Self-contained Mini Spore Ampules for Monitoring Liquid Steam Processes, with Log 5 spore population.
Important: This item must be shipped UPS OVERNIGHT on ice packs
Size: 40mm x 6.5mm diam. x 0.7ml (volume)
50 per box
Biological indicators can be used in Steam Autoclaves at 121°C to 137°C for monitoring liquid steam processes and dry loads. Must be used with Bionova IC10/20 incubator. For laboratory or industrial use only.
Call for quantity discounts 877-561-0500
Note: Spore ampoules must be kept refrigerated and ship overnight. These are specially made for monitoring liquid sterilization in steam autoclaves.
Must be used with Bionova IC10/20 incubator sold at Duraline BioSystems, Inc
Instructions for Use:
Place Mini Spore Ampules inside representative materials (containers of liquid) or within the autoclave chamber directly. Package or wrap product as usual, if applicable. Locate product or Mini 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 Mini Spore Ampules or product from sterilizer. Allow product or Spore Ampules to cool to the touch. No activation is required.
Incubation: Place the processed Mini Spore Ampules, one Negative Control Ampule and one Positive Control (unprocessed Mini Spore Ampule) in a vertical position in an incubator at 60°C to 65°C for a minimum of 48 hours.
Monitoring: Examine the Mini Spore Ampules daily during incubation. Record observations. All positive Mini Spore Ampules should be disposed of immediately. Do not continue to incubate a positive Ampule. 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).
Interpretation: Negative Control: 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 Mini Spore Ampules, where applicable.
Positive Control Mini Spore Ampule: The Positive Control Ampule should exhibit a color change to Yellow and/or demonstrate turbidity. Utilize the Positive Control as a color comparison for the exposed Ampules, where applicable. If the positive control does not demonstrate a Yellow color and/or turbidity, the results for the test Ampules should not be considered valid. Verify incubation conditions were met.
Test Mini 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.
For unexpected positives, it is recommended that a Gram stain be performed. Gram positive rods are indicative for the indicator organism.
Important: This item must be shipped UPS OVERNIGHT on ice packs
Size: 40mm x 6.5mm diam. x 0.7ml (volume)
50 per box
Biological indicators can be used in Steam Autoclaves at 121°C to 137°C for monitoring liquid steam processes and dry loads. Must be used with Bionova IC10/20 incubator. For laboratory or industrial use only.
Call for quantity discounts 877-561-0500
Note: Spore ampoules must be kept refrigerated and ship overnight. These are specially made for monitoring liquid sterilization in steam autoclaves.
Must be used with Bionova IC10/20 incubator sold at Duraline BioSystems, Inc
Instructions for Use:
Place Mini Spore Ampules inside representative materials (containers of liquid) or within the autoclave chamber directly. Package or wrap product as usual, if applicable. Locate product or Mini 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 Mini Spore Ampules or product from sterilizer. Allow product or Spore Ampules to cool to the touch. No activation is required.
Incubation: Place the processed Mini Spore Ampules, one Negative Control Ampule and one Positive Control (unprocessed Mini Spore Ampule) in a vertical position in an incubator at 60°C to 65°C for a minimum of 48 hours.
Monitoring: Examine the Mini Spore Ampules daily during incubation. Record observations. All positive Mini Spore Ampules should be disposed of immediately. Do not continue to incubate a positive Ampule. 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).
Interpretation: Negative Control: 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 Mini Spore Ampules, where applicable.
Positive Control Mini Spore Ampule: The Positive Control Ampule should exhibit a color change to Yellow and/or demonstrate turbidity. Utilize the Positive Control as a color comparison for the exposed Ampules, where applicable. If the positive control does not demonstrate a Yellow color and/or turbidity, the results for the test Ampules should not be considered valid. Verify incubation conditions were met.
Test Mini 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.
For unexpected positives, it is recommended that a Gram stain be performed. Gram positive rods are indicative for the indicator organism.
- Log 4 spore population
- Size: 47mm X 10.6mm x 1ml
- Volume: 1mL
- Quantity of mini spore ampules: 50 per box
- Sterilization Type: Steam
- Loads: Liquid and Dry loads
- Incubator: Bionova IC10/20
Spore Ampules Log 4 BI-SA-L4 Technical Data Sheet
Compliance:
ISO 11138-1 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11138-3 Sterilization of healthcare products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes.
USP <55> Biological Indicators - Resistance Performance Tests
True Indicating has a validated method for Total Viable Spore Count. Please inquire for the Technical Bulletin which outlines the recommended methodology.
Compliance:
ISO 11138-1 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11138-3 Sterilization of healthcare products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes.
USP <55> Biological Indicators - Resistance Performance Tests
True Indicating has a validated method for Total Viable Spore Count. Please inquire for the Technical Bulletin which outlines the recommended methodology.
| Image | Product Code | Description | Spore Population | Size | Volume | Quantity | Price/box | View |
|
BI-MSA-ATM05 | Mini Spore Ampoule | Log 5 | 40mm x 6.5mm diam | 0.7ml |
50/box plus |
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BI-MSA-ATM06 | Mini Spore Ampoule | Log 6 | 40mm x 6.5mm diam | 0.7ml |
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BI-SA-L4 | Spore Ampoule | Log 4 | 47mm x 10.6mm | 1ml |
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BI-SA-L5 | Spore Ampoule | Log 5 | 47mm x 10.6mm | 1ml |
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BI-SA-L6 | Spore Ampoule | Log 6 | 47mm x 10.6mm | 1ml |
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