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Self-Contained Spore Ampoules to Monitor Liquid Steam Sterilization, Log 4 spore population, Size: 47mm X 10.6mm x 1ml (volume), 50/box
Price:
$
220.00
Availability:
OVERNIGHT SHIPPING ONLY
Product Code:
BI-SA-L4
Qty:
Description
Technical Specs
Literature
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.
Image
Product Code
Description
Spore Population
Size
Volume
Quantity
Price/box
BI-MSA-ATM05
Mini Spore Ampoule
Log 5
40mm x 6.5mm diam
0.7ml
50/box plus
$220
BI-MSA-ATM06
Mini Spore Ampoule
Log 6
40mm x 6.5mm diam
0.7ml
50/box plus
$220
BI-SA-L4
Spore Ampoule
Log 4
47mm x 10.6mm
1ml
50/box plus
1
$220
BI-SA-L5
Spore Ampoule
Log 5
47mm x 10.6mm
1ml
50/box plus
$220
BI-SA-L6
Spore Ampoule
Log 6
47mm x 10.6mm
1ml
50/box plus
$339
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.
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