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Crosstex - Biological Indicators
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Information on Crosstex Biological Indicatiors
Go to Sterilisation Products website
Crosstex offers a complete line of Biological Indicators (BI's) designed to meet the ANSI/AAMI/ISO/EN 11138 standards.
 
Crosstex Biological Indicators:
  • Are used to evaluate the effectiveness of sterilisation processes.
  • Are essential in performing sterilisation cycle validation.
  • Are used for ethylene oxide gas, dry heat, steam, vapourised hydrogen peroxide (VHP), radiation, steam-formaldehyde and chlorine dioxide sterilisation processes.
  • Available in a wide range of organisms, populations and packaging.
  • Are available as:
- spore strips and spore discs
- spore coupons (stainless steel), spore wires and spore threads
- spore ampoules and spore suspensions
- self-contained biological indicators (SCBI)
 
EASY TO USE - Following sterilisation, traditional spore strips, discs, coupons and threads are cultured in soybean-casein digest broth (SCDB) following U.S. Pharmacopoeia (USP) standards. Spore ampoules are incubated after exposure to the steam sterilisation process. Self-contained biological indicators (SCBI) can be immediately activated by the user and then incubated.
Biological Indicators
Go to Spore Strips Spore Strips
Go to Mini-Spore Strips Mini Spore Strips
Go to Spore Discs Spore Discs
Go to Spore Coupons and Spore Threads Stainless Steel Spore Coupons, Discs and Wires and Spore Threads
Go to SCBI's Self Contained Biological Indicators (SCBI)
Go to Spore Ampoules and Mini-Spore Ampoules Spore Ampoules and Mini-Spore Ampoules
Go to Spore Suspensions Spore Suspensions
Go to Prepared Culture Media Prepared Culture Media
Go to Custom Biological Indicators Custom Biological Indicators
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Go to Hyrogen Peroxide Biological Indicators Vapourised Hydrogen Peroxide (VHP) Biological Indicators
Literature and Technical Information
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Product Type Product Description
Traditional Spore Strips
Go to Sterilisation Products websiteCrosstex offers a full line of traditional spore strips for use in monitoring Ethylene Oxide (EO)/Dry Heat, Steam, Chlorine Dioxide and Radiation sterilisation processes and which are ISO11138-1 compliant. Spore strips for use with Dry Heat (temperatures up to 160°C) are ISO11138-4 compliant. Spore strips are made oinoculated filter paper (7mm x 38mm), packaged individually in boxes of 100 spore strips. Spore strips are certified for species, population, purity, resistance, (D-value, Z-value, survival/kill data - where applicable) and expiration date.

Traditional Spore Strip Configurations:
Process and Indicator Microorganism S pore Population Shelf Life1 (months) Packaging
Steam - G. stearothermophilus 104-106 24 Glassine
Steam - B. subtilis 106 15 Glassine
       Ethylene Oxide (EO)/Dry Heat - B. atrophaeus 104-106 24 Glassine
Dry Heat Only - B. atrophaeus 106 24 Glassine
Radiation/E-Beam - B. pumilus  104-106 24 Glassine
Chlorine Dioxide - G. stearothermophilus 106 30 Tyvek/Tyvek
Steam-formaldehyde - G. stearothermophilus 105-106 30 Glassine
Note 1: Shelf-life from date of manufacture when stored at room temperature (15-30°C).
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Mini Spore Strips
Go to Sterilisation Products websiteMini Spore Strips (2mm x 10mm) will fit into small areas of a device where a standard-sized (7mm x 38mm) spore strip cannot be used, such as within a syringe barrel, inside tubing or under a cap. Spore strips are available packaged in glassine envelopes (50 x 25mm), mini-glassine envelopes (25 x 25mm) or in bulk and with a population of 106 spores per strip.

Crosstex Mini Spore Strips are available in pack of 100 with a 30 month shelf-life from date of manufacture when stored at room temperature (15-30°C). Mini spore strips are certified for species, population, purity, resistance, (D-value, Z-value, survival/kill data - where applicable) and expiration date.

Mini-Spore Strip Configurations:
Process and Indicator Microorganism Spore Population Shelf Life1 (months) Packaging
Steam - G. stearothermophilus 106 30 Glassine
Steam - G. stearothermophilus 106 30 Mini-Glassine
Steam - G. stearothermophilus 106 30 Bulk
Ethylene Oxide (EO)/Dry Heat - B. atrophaeus 106 30 Glassine
Ethylene Oxide (EO)/Dry Heat - B. atrophaeus 106 30 Mini-Glassine
Ethylene Oxide (EO)/Dry Heat - B. atrophaeus 106 30 Bulk
Note 1: Shelf-life from date of manufacture when stored at room temperature (15-30°C).
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Spore Discs
Go to Sterilisation Products websiteCrosstex Spore Discs are available in a number of formats with either paper and glass fibre carriers. Spore Discs are available in diameters of 3mm, 6mm and 9mm and are available in glassine envelopes, Tyvek/Mylar envelopes and packaged bulk. Spore Discs will fit into small areas of a device where a standard-sized (7mm x 38mm) spore strip cannot be used, such as within a syringe barrel, inside tubing or under a cap. Spore Discs are available in a range of spore populations from 104 to 106 spores per disc.

Crosstex Spore Discs are available in packs of 100 with an 12 or 24 month shelf-life (depending on microorganism and carrier type) from date of manufacture when stored at room temperature (15-30°C). Discs are certified for species population, purity, resistance, (D-value, Z-value, survival/kill data - where applicable) and expiration date.

Indicator Microorganisms:
  • Bacillus atrophaeus - Ethylene Oxide (EO)/Dry Heat
  • Bacillus atrophaeus - Vapourised Hydrogen Peroxide (VHP)
  • Geobacillus stearothermophilus - Steam
  • Geobacillus stearothermophilus - Vapourised Hydrogen Peroxide (VHP)
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Stainless Steel Spore Coupons, Discs and Wires and Spore Threads
Go to Sterilisation Products websiteCrosstex Stainless Steel Spore Coupons are available packaged in Tyvek/Mylar envelopes. The 316 Stainless Steel Spore Coupons are 34mm x 7mm x 0.9mm in size and are available in packs of 100 with a range of populations from 104 to 106 spores per coupon. Steel Spore Discs are 6mm in diameter, packaged in Tyvek/Mylar envelopes and are available in packs of 100 with a population of 106 spores per disc. Steel Spore Wires are 40mm in length, packaged bulk in packs of 100 with a population of 106 spores per wire.

Crosstex Spore Threads are 25mm in length and are made of cotton. They are available in bulk or in glassine envelopes in packs of 100 with a population of 105 and 106 spores per thread.

Indicator Microorganisms:
  • Bacillus atrophaeus: Vapourised Hydrogen Peroxide (VHP) - SS Spore Coupons and Steel Discs
  • Bacillus atrophaeus: Ethylene Oxide (EO)/Dry Heat - Spore Threads and Spore Wire
  • Geobacillus stearothermophilus: Vapourised Hydrogen Peroxide (VHP) - SS Spore Coupons, Spore Disc and Spore Wire
  • Geobacillus stearothermophilus: Steam - Spore Threads and Spore Wire
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Self Contained Biological Indicators (SCBI)
Go to Sterilisation Products websiteCrosstex range of SporView®, SporView®10 Self Contained Biological Indicators (SCBI's) and Traditional Self-Contained Biological Indicators for monitoring steam sterilisation have a spore population of either 105 or 106 spores per unit and with 106 spore per unit for Ethylene Oxide. Vapourised Hydrogen Peroxide SporView® SCBI's are available with a spore population of 106 per unit. All SCBI's contain a crushable glass ampoule with recovery media and a paper disc inoculated with the indicated spore population.

SporView® SCBI's are available in boxes of 100 units and the Traditional SCBI's and SporView®10 SCBI's are available in boxes of 50 units and are stored at room temperature (15-30°C). The Traditional SCBI's are 13mm x 61mm and the SporView® and SporView®10 are 8.4mm x 45.5mm. The Tradtional SCBI's and the SporView® provide a result after 24hr incubation period whereas the SporView®10 provide a result after only 10hr incubation period.

All SCBI's are stored at room temperature (15-30°C) and are certified for species, population, purity, resistance (D-value, Z-value - where applicable) and expiration date.

Indicator Microorganisms:

  • Bacillus atrophaeus - Ethylene Oxide (EO)/Dry Heat sterilisation
  • Geobacillus stearothermophilus - Steam
  • Geobacillus stearothermophilus - Vapourised Hydrogen Peroxide (VHP)
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Spore Ampoules and Mini-Spore Ampoules
Go to Sterilisation Products websiteCrosstex Spore Ampoules are used in monitoring the efficacy of steam sterilisation processes. Spore ampoules are ideal for use in validation of liquid sterilisation cycles. Ampoules are also suitable for monitoring non-liquid loads. No activation is required: simply expose Spore Ampoule to sterilisation process and then incubate.

All Spore Ampoules are hermetically sealed type I borosilicate glass containing a modified Soybean Casein Digest Broth with bromocresol purple pH indicator and the specified spore population. Geobacillus stearothermophilus spore populations of 105 (1mL ampoule) and 106 (0.4mL and 1mL ampoules) spores per ampoule are available. Mini-Spore Ampoules containing Bacilus subtilis with a spore population of 106 spores per ampoule are available in the 0.4mL ampoule size. Standard Spore Ampoules (1mL) are 10.8 x 58mm in size and the Mini-Spore Ampoules (0.4mL) are 6.4 x 32mm in size.

Spore Ampoules are incubated according to the growth requirements of the microorganism. Growth is evident by either turbidity and/or a colour shift from a purple to or towards a yellow colour. Spore Ampoules are packaged as in 15, 50 and 100 ampoules/box (not all combinations of spore population, ampoule size and pack sizes are available) and are stored refrigerated (2-8°C).
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Spore Suspensions
Go to Sterilisation Products websiteCrosstex Spore Suspensions are pure suspensions of viable spores from specific organisms of known resistance to various sterilisation processes. They are suspended in water for injection and provided in pharmaceutical vials containing 10 mL of suspension. 

Spore suspensions are available in a range of populations from 102 to 108 spores per 0.1mL for each organism. Spore Spore suspension are stored refrigerated (2-8°C).

Indicator Microorganisms:
  • Bacillus atrophaeus - Ethylene Oxide (EO)/Dry Heat
  • Geobacillus stearothermophilus - Steam
  • Bacillus subtilis - Steam
  • Bacillus pumilus - Radiation
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Prepared Culture Media
Go to Sterilisation Products websiteCrosstex prepared culture media consists of an exclusively formulated Trypticase® Soy Broth (TSB) modified with a pH indicator. A reduced incubation time of 24 hours for steam sterilisation has been validated when Crosstex Biological Indicator Spore Strips and Discs are used in conjunction with Crosstex Prepared Culture Media.
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Custom Biological Indicators
 
Go to Sterilisation Products websiteCrosstex can manufacture custom strips, discs and other configurations to meet your specifications or private label production. Crosstex also provide biological indicators with alternative organisms. Please contact us for more information on the range of custom biological indicators available from Crosstex.
 
Examples:
  • Inoculated Threads
  • Fibreglass Carriers
  • Stainless Steel Wires
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