![]() ![]() 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. If the positive control does not demonstrate a yellow color and/or turbidity, the results for test Spore Ampules should not be considered valid. Utilize the Positive 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 Negative Control as a color comparison for the exposed Spore Ampules, where applicable. Interpretation: Negative Control (Crosstex Code SA1-NC-10): The Negative Control Ampule should not exhibit a color change to yellow and/or demonstrate turbidity. Gram positive rods are characteristic of the indicator organism. All positive Spore Ampules should be disposed of immediately.įor unexpected positives, it is recommended that a Gram stain be performed. Monitoring: Examine the Spore Ampules daily during incubation. Incubation: Place the processed Spore Ampules, the Negative Control and the Positive Control in a vertical position in an incubator at 58☌ to 62☌ for a minimum of 48 hours. ![]() ![]() If a Positive Control is needed, label one unprocessed Spore Ampule as “Positive Control”. As such, Spore Ampules left in the chamber for extended periods of time (>24 hours) post-exposure should be discarded.Ĭontrols: A Negative Control ampule, Crosstex Code SA1-NC-10, may be used in conjunction with the Spore Ampules, where a negative control is required. Leaving the Spore Ampules in the sterilizer post-exposure may have a negative impact on the product’s performance. Handle Spore Ampules with care as contents are extremely hot. Allow product or Spore Ampules to cool to the touch. Run the cycle.Īfter sterilization or exposure, remove Spore Ampules or product from sterilizer. 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. Package or wrap product as usual, if applicable. Liquid Volumes of LESS than 10 mLs choose: 0.4 mL Mini Spore AmpuleĢ4 month self life from date of manufactureĮxposure: Spore Ampules may be placed inside representative materials (containers of liquid) or within the chamber directly. Liquid Volumes of 10 mLs or more choose: 1 mL Spore Ampule Use Incubator LS-2070031 with 1 mL Spore Ampules. 1 ml Spore Ampules and 0.4 mL Mini Spore Ampules provide easy visual confirmation of sterilization within 48 hours, without the need for difficult and time-consuming laboratory work. stearothermophilus spores and a specially-formulated culture medium that turns a dramatic yellow if spores grow. Both biological indicator ampoules contain G. ![]() Use 1 ml Spore Ampules in liquid containers with greater than 10 mL and 0.4 mL Mini Spore Ampules when liquid quantities are less than 10 mL. You can choose between two spore populations (Log 5 or Log 6) based on your local regulatory requirements. Spore & Mini Spore are self-contained Biological Indicator (BI) ampoules for monitoring steam sterilization of liquids, such as media. Spore & Mini Spore Biological Indicators for Liquid Loads ![]()
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