Product Description
Pure suspensions of viable spores with a known population and resistance to Steam sterilization processes.
Intended Use
Crosstex Spore Suspensions are standardized suspensions of spores appropriate for direct inoculation onto
samples for sterility, bioburden, and bacteriostasis testing. Spore Suspensions are labeled For Industrial Use Only.
Instructions for Use
Perform inoculation operations in a clean area which is remote from the sterility testing area.
Samples to be inoculated should be representative of product being sterilized.
For most purposes, inoculate product with targeted population level of spores to provide a suitable challenge. Note:
Suspensions are standardized on the basis of number of spores per 0.1 mL of suspension.
Shake vial vigorously 10 times or vortex for 30 seconds before each use. Excessive vortexing or shaking may
cause adhesion of spores to the vial and result in reduced recovery. Do not sonicate.
Use a suitable sterile pipette or syringe to accurately measure and deliver the volume of suspension to be utilized.
If a syringe is used, disinfect septum surface and pull syringe plunger halfway back. Insert needle through the
septum, push the plunger in, and slowly withdraw plunger to fill syringe to desired volume.
If a pipette is used, remove cap and septum and insert pipette. Withdraw desired volume.
Deposit suspension onto product. The area to be inoculated should be the one most difficult to sterilize. Return
vial(s) of remaining suspension to refrigerator storage (2°C to 8°C) after use.
Allow product to dry at room temperature (20°C to 30°C) for approximately 24 hours or until visibly dry. Some
devices with small lumens may take longer to dry.
Package inoculated product exactly like product being sterilized and identify prominently as “Inoculated Test
Samples.”
Exposure: Distribute the test samples throughout the sterilizer load, as outlined in associated validation protocol or
work instruction specific to your process. Crosstex can assist with the development of your sterilization validation.
Run the cycle.
After sterilization or exposure, remove the product from the sterilizer.
Culturing: Aseptically transfer the exposed test samples into Soybean Casein Digest Broth (SCDB) as soon as
possible following the exposure.
Incubation: Incubate the tubes at 55°C to 60°C for seven days or per a validated incubation period.
Monitoring: Examine the tubes daily during incubation. Record observations.
Interpretation: Tubes which demonstrate turbidity with cream colored sediment are considered positive for growth
of Geobacillus stearothermophilus. Tubes which remain clear and without sediment are considered negative for
growth.
Compliance ISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements USP (where applicable) Crosstex has a validated method for Total Viable Spore Count. Please inquire for the Technical Bulletin entitled Population Verification of Spore Suspensions to ensure consistent methodologies are being utilized when performing verification testing.
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 |