NAMSA - Biological Indicators
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Information on NAMSA Biological Indicatiors
Go to NAMSA websiteNAMSA offers the industry's most complete line of Biological Indicators (BI) designed to meet the ANSI/AAMI/ISO/EN 11138 standards.
 
NAMSA Biological Indicators are:
  • Used to evaluate the effectiveness of sterilisation processes.
  • Essential in performing sterilisation cycle validation.
  • Used for ethylene oxide gas, dry heat, steam and radiation sterilisation processes.
  • Available in a wide range of organisms, populations and packaging.
  • Available as strips (standard size or mini), discs, suspensions, self-contained, ampoules and custom configurations.
 
EASY TO USE - Only minimal training is required to use NAMSA Biological Indicators.  Following sterilisation, spore strips or discs are cultured in soybean-casein digest broth (SCDB) following U.S. Pharmacopoeia (USP) standards. Alternatively, processed or exposed biological indicators may be returned to NAMSA for testing. NAMSA self-contained biological indicators (SCBI) and spore ampoules may be immediately activated by the user and then incubated at 55-60°C for 24 or 48 hours. A colour change in the media of a processed biological indicator indicates sterilisation process failure.
Biological Indicators
Go to Spore Strips Spore Strips
Go to Mini-Spore Strips Mini Spore Strips
Go to Spore Discs Spore Discs
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
Go to Incubators Incubators for SCBI's and Spore Ampoules
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 ProductsNEW and Featured Products
Go to Custom CPI's Custom Chemical Process Indicators (CPI) - Labels on Labels
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 various sterilisation processes including Ethylene Oxide (EO), Dry Heat, Steam and Radiation. Spore strips are available in populations from 102 to 108 for each organism. Spore strips consist of inoculated filter paper, 1.25" x 0.25", packaged in glassine pouches. 

NAMSA strips are available in packs of 100 with an 18 or 24 month shelf-life (depending on microorganism) 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:
  • Ethylene Oxide (EO)/Dry Heat - Bacillus atrophaeus
  • Steam - Geobacillus stearothermophilus
  • Radiation - Bacillus pumilus
  • Combination Spore Strips - Geobacillus stearothermophilus and Bacillus atrophaeus
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Mini Spore Strips
Go to NAMSA websiteMini Spore Strips (2 mm x 10 mm) will fit into small areas of a device where a standard-sized (6 mm 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 or in bulk (without glassine envelope).

NAMSA Mini Spore Strips are available in pack of 100 with an 18 or 24 month shelf-life (depending on microorganism) 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:
  • Ethylene Oxide (EO)/Dry Heat - Bacillus atrophaeus
  • Steam - Geobacillus stearothermophilus
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Spore Discs
Go to NAMSA websiteNAMSA Spore Discs are packaged in bulk (without glassine envelopes) and are available in sizes of 6mm (1/4") or 3mm (1/8") diameter. Spore Discs will fit into small areas of a device where a standard-sized (6 mm x 30 mm) spore strip cannot be used, such as within a syringe barrel, inside tubing or under a cap.

NAMSA Spore Discs are available in packs of 100 with an 18 or 24 month shelf-life (depending on microorganism) 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:
  • Ethylene Oxide (EO)/Dry Heat - Bacillus atrophaeus
  • Steam - Geobacillus stearothermophilus
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Self Contained Biological Indicators (SCBI)
Go to NAMSA websiteNAMSA offers Self-Contained Biological Indicators (SCBI's) for monitoring steam (spore population = 105 and 106) and Ethylene Oxide (population 106) sterilisation processes. Each SCBI unit consists of a plastic container with a cap, a crushable glass ampoule with recovery media, and a paper disc inoculated with spores.

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:
  • Ethylene Oxide (EO)/Dry Heat - Bacillus atrophaeus
  • Steam - Geobacillus stearothermophilus
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Spore Ampoules
Go to NAMSA websiteNAMSA offers spore ampoules for use 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 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 population of Geobacillus stearothermophilus spores (1x105 and 1x106). Growth is evident by either turbidity and/or a colour shift from a purple to or toward a yellow colour.

Spore Ampoules are available in 1mL and 4mL sizes and are packaged as in 10, 15, 50 and 100 ampoules/box (not all combinations of ampoule sizes 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:
  • Ethylene Oxide (EO)/Dry Heat - Bacillus atrophaeus
  • Steam - Geobacillus stearothermophilus
  • Radiation - Bacillus pumilus
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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
  • Process Challenge Device (PCD) Assembly
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Incubators for Self Contained Biological Indicators (SCBI) and Spore Ampoules
Go to NAMSA websiteNAMSA offers aluminium dry-block incubators for use in conjunction with both the SCBI's and Spore Ampoules. Available in either an ambient to 35°C or ambient to 60°C temperature range (+/-2°C), the incubators have a removable, clear polycarbonate 12-well rack allowing for full viewing of all indicators at a glance.
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