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NAMSA - Biological Indicators
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Information on NAMSA Biological Indicatiors
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NAMSA offers a complete line of Biological Indicators (BI's) designed to meet the ANSI/AAMI/ISO/EN 11138 standards.
 
NAMSA 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) and radiation 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 discs, spore wires and spore threads
- spore ampoules and spore suspensions
- self-contained biological indicators
 
EASY TO USE - Following sterilisation, spore strips, discs, coupons and threads are cultured in soybean-casein digest broth (SCDB) following U.S. Pharmacopoeia (USP) standards. Self-contained biological indicators (SCBI) and spore ampoules may be immediately activated by the user and then incubated at the appropriate temperature for 24 or 48 hours.
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 Spore Ampoules
Go to Spore Suspensions Spore Suspensions
Go to Custom Indicators Custom Biological Indicators
Specific Product/Application Areas:
Go to CPI Product Information Chemical Process Indicators (CPI)
Go to QC Organism Product Information QC Organisms/Growth Promotion
Go to NAMSA Testing and Other Services Information Testing and Other Services
Go to NEW and Featured Products NEW and Featured Products
Go to Hyrogen Peroxide Biological Indicators Vapourised Hydrogen Peroxide (VHP) Biological Indicators
Go to Spore Strips and Discs Spore Strips and Discs for Sterilisation Monitoring
Literature
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Product Type Product Description
Spore Strips
Go to NAMSA websiteNAMSA offers a full line of spore strips for use in monitoring Ethylene Oxide (EO), Dry Heat, Steam and Radiation sterilisation processes. Spore strips are available in populations from 102 to 108 spores per strip. Spore strips consist of inoculated filter paper (6mm x 30mm), packaged individually in glassine envelopes. 

NAMSA strips are available in packs of 100 with a 24 month shelf-life (15 months B.subtilis) when stored at room temperature (15-30°C). Spore strips are certified for species, population, purity, resistance, (dvalue, zvalue, survival/kill data - where applicable) and expiration date.

Indicator Microorganisms:
  • Bacillus atrophaeus - Ethylene Oxide (EO)/Dry Heat
  • Bacillus atrophaeus - Dry Heat Only
  • Geobacillus stearothermophilus - Steam
  • Bacillus subtilis - Steam
  • Bacillus pumilus - Radiation
  • Geobacillus stearothermophilus and Bacillus atrophaeus - Combination Spore Strips for Ethylene Oxide (EO)/Dry Heat/Steam
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Mini Spore Strips
Go to NAMSA websiteMini Spore Strips (2mm x 10mm) will fit into small areas of a device where a standard-sized (6mm x 30 mm) 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 x25mm), mini-glassine envelopes (25 x 25mm) or in bulk and with a population of 106 spores per strip.

NAMSA Mini Spore Strips are available in pack of 100 with a 24 month shelf-life when stored at room temperature (15-30°C). Mini spore strips are certified for species, population, purity, resistance, (dvalue, zvalue, survival/kill data - where applicable) and expiration date.

Indicator Microorganisms:
  • Bacillus atrophaeus - Ethylene Oxide (EO)/Dry Heat
  • Geobacillus stearothermophilus - Steam
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Spore Discs
Go to NAMSA websiteNAMSA Spore Discs are available in a number of formats with either paper or 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 (6mm x 30mm) 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.

NAMSA Spore Discs are available in packs of 100 with an 12 or 24 month shelf-life (depending on microorganism and carrier type) when stored at room temperature (15-30°C). Discs are certified for species population, purity, resistance, (dvalue, zvalue, 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 NAMSA websiteNAMSA 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.

NAMSA 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 NAMSA websiteNAMSA offers Self-Contained Biological Indicators (SCBI's) for monitoring steam sterilisation with a spore population of either 105 or 106 spores per SCBI and with 106 spore per SCBI for Ethylene Oxide. Hydrogen Peroxide SCBI's are available with a spore population of 106 per SCBI. Each SCBI unit consists of a plastic container with a cap, a crushable glass ampoule with recovery media, and a paper disc inoculated with the indicated spore population.

The SCBIs are available in boxes of 50 units and are stored at room temperature (15-30°C). SCBIs are certified for species, population, purity, resistance (dvalue, zvalue - 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
Go to NAMSA websiteNAMSA 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. Ampoules containing Bacilus subtilis with a spore population of 106 spores per ampoule are available in the 0.4mL ampoule 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 NAMSA websiteNAMSA 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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Custom Biological Indicators
 
Go to NAMSA websiteNAMSA can manufacture custom strips, discs and other configurations to meet your specifications or private label production. NAMSA also provide biological indicators with alternative organisms. Please contact us for more information on the range of custom biological indicators available from NAMSA.
 
Examples:
  • Inoculated Threads
  • Fibreglass Carriers
  • Stainless Steel Wires
  • Process Challenge Device (PCD) Assemblies
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