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Spore Strips

Raven Labs offers a complete line of spore strips for sterility testing in various sterilization environments for both Healthcare and Industrial applications. Raven's products are manufactured in accordance with USP Guidelines and the US Food & Drug Administration's Quality System Regulations.

24-Hour Incubation claim (steam) receives 510K
(Raven's spore strips used with Raven's prepared culture media)

Geobacillus stearothermophilus1 - For use in steam sterilization at 121.1°C (250 F) to 135°C (275 F), Low Temperature Steam w/Formaldehyde and Chemiclave®. After exposure to sterilant, incubate strips at 55°C.

Bacillus atrophaeus1 - For use in Ethylene Oxide (600 mg/L), Dry Heat Sterilization (D-value calculated at 160°C), and formaldehyde fumigation. After exposure to sterilant, incubate strips at 35°C.

Bacillus pumilus1 - Used for validation of irradiation sterilization processes. After exposure to sterilant, incubate strips at 35°C.

Combined Species Spore Strips - G. stearothermophilus1 (105) and B. atrophaeus1 (106) on each strip. For use in Steam, EO, Dry Heat or Chemiclave® sterilizers. Current EN guidelines do not recommend the use of Combined species spore strips. In-house studies have shown the performance of dual species strips to be essentially equivalent to single species spore strips made from the same spore batch.

Specifications

Spore strips are in Schleicher & Schuell filter paper (#470) - size 6.4mm x 38.1mm - packaged in a peel open glassine paper pouch. Glassine paper is permeable to sterilant but resistant to moisture and air at ambient temperature/pressure. This allows the user to transport the strip within the glassine from the sterilizer to a laminar flow hood, where it can be transferred into recovery medium. Populations of strips are typically from 1.0 X 10n to 4.0 X 10n. Expiration is two years from date of manufacture. Lot number and expiration date are printed on each glassine.

Certification

Raven spore strips are certified for Species, Population, D-value, z-value (where appropriate) and Expiry. D-values are within suggested ranges mentioned in USP and suitable for hospital use. Raven also provides spore strips that comply with EN/ISO and other international requirements. Raven follows USP in recommending Tryptic Soy Broth (SCBD) as a recovery medium. Use of any other medium may adversely affect results.

Packaging

1) Bags of 100 strips - clear plastic re-sealable bag
Species Catalog # Minimum Population Log
B. atrophaeus 1-6100 1,000,000 106
G. stearothermophilus 3-5100 100,000 105
G. stearothermophilus 3-6100 1,000,000 106
B. pumilus 7-6100 1,000,000 106

2) Hospital Pack - 25 Envelopes (Tests) - Each test consists of three spore strips - two to be placed in the sterilizer and one control. The two strips exposed in the sterilizer are to be returned to the envelope with the unexposed strip and all three are to be sent to the hospital micro lab for in-house culturing. The envelope has space for the technician to write pertinent information about the sterilizer load, contents and test results. Available with G. stearothermophilus, B. atrophaeus, or Combined species strips.

3) Monitoring Service (for domestic clients only) - Expose the strips in your sterilizer, place in the return envelope, mail them to us and have Raven culture them for you! You receive a report with the results. Perfect for dental or doctor offices or for an independent verification of your practices. Service comes with 12 or 24 envelopes each containing a test and control strip. Available with Combined species strips only.

4) Raven Culture Test Kit - Spore Strips & for Culturing Strips In-house - 24-Hour incubation when used in Steam at 121-135°C.
a) Catalog # C-1080P - contains 25 combined spore strips and 25 test tubes of specially formulated media (TSB w/acid indicator).

b) Catalog # C-1081P - contains 100 combined spore strips and 100 test tubes of media.

c) ProPact (Peracetic Acid Culture Test kit) is intended for use in monitoring the efficacy of the System 1 peracetic acid sterilization process.


Other populations, other species, and other carriers are available for industrial uses. Please see our Industrial BI's page.

Note:
  1. Derived from recognized reference strains as specified within USP, ISO or EN guidelines. These products are not certified as being representative of the reference strain and they should therefore not be used where a reference culture is specified.
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