Product Description
Biological Indicator Spore Strips for monitoring low temperature Steam processes consist of:
An inoculated carrier, 7 mm x 38 mm (1.5” x 0.281”) strip, of Bacillus subtilis (Cell Line 5230)
Primary packaging in a white glassine pouch
Intended Use
The Spore Strips may be utilized to monitor Steam sterilization process efficacy. Bacillus subtilis is typically utilized
to monitor low temperature steam processes (<121°C). The Spore Strips are labeled For Industrial Use Only
Instructions for Use
Place Spore Strips (a minimum of 10 per exposure is recommended) inside representative materials to be sterilized
or within the chamber directly. Package or wrap product as usual, if applicable.
Locate the test packages or Spore Strips in areas most difficult to sterilize, as outlined in your specific sterilization
validation protocol (usually four corners front, four corners rear, center-center and center-top) or according to
standard operating procedure. Run the cycle.
After sterilization or exposure, remove Spore Strips or product from sterilizer.
Aseptically remove the Spore Strip from the primary packaging and transfer to Soybean Casein Digest Broth
(SCDB).
Transfer a minimum of one Spore Strip which has not been exposed in a sterilization process as a Positive Control.
Incubation: At least one unused tube of culture medium from the same lot should be incubated with the test series
as a Negative Control. Place the cultured Spore Strips, the Positive Control and the Negative Control in an
incubator set at 30°C to 35°C. Incubate for a minimum of seven days or per a validated reduced incubation period.
Monitoring: Examine the Spore Strips daily during incubation. Record observations
Interpretation:
Tubes which demonstrate turbidity with a cream-colored pellicle are considered positive for growth of Bacillus
subtilis. Tubes which remain clear and without pellicle formation are considered negative for growth.
For unexpected positives, it is recommended that a Gram stain be performed. Gram positive rods are characteristic
of the indicator organism.
Positive Control: Tube should demonstrate turbidity. If the Positive Control does not result in growth, the exposure
is considered invalid. Check the conditions during incubation and verify the capability of the medium to support
growth.
Negative Control: Tube of medium should remain clear. If the Negative Control results in growth, there is a potential
for false positives.
Physical Properties
Process Steam
Strip Dimension 7 mm x 38 mm (1.5” x 0.281”)
Glassine Dimension 25 mm x 75 mm
Packaging 100/Box
Monitoring Frequency
For greatest control of sterilized goods, it is recommended that a minimum of ten (10) Spore Strips be included with every load.
Performance Characteristics
Population 1.0 to 5.0 x 106 per Spore Strip
Purity No evidence of contamination present in sufficient numbers to adversely affect the
finished product.
Steam Resistance D values at 115°C, 118°C and 121°C
Post-Market Criteria
Population: 50% to 300% of certified population
D value: ± 20% of the certified D value
Disposal
Autoclave for not less than 30 minutes at 121ºC or per other validated disposal cycle prior to discard.
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| Brand | Pyrex |