Self-Contained Biological Indicators (SCBI)
NAMSA offers Self-Contained Biological Indicators (SCBI) for
monitoring steam sterilization pr
ocesses in spore population
levels of 105 and 106 and for Ethylene Oxide (EO) processes in
a 106 population. Each SCBI unit consists of a plastic vial with a
cap, a crushable glass ampule with recovery media, and a paper
disc inoculated with spores. SCBIs are ideal for use in sterilization
processes where traditional Biological Indicator strips are
utilized, however eliminates the need for aseptic transfer of the
BI to culture media and offers a shortened incubation period.
The recovery media consists of a modified Soybean Casein
Digest Broth with pH indicator. Activate for incubation by depressing
the cap completely and crushing the media ampule.
Growth is evident by either turbidity and/or a color shift of the
media. SCBIs are labeled with the shorter shelf life of the two
components; the inoculated disc and media ampule which have
independent expiration periods. Store under room temperature
(15ºC - 30ºC) conditions. SCBIs are offered in boxes of 50
units. Each box is accompanied by a Certificate of Analysis and
Instructions for Use. NAMSA SCBIs are compliant with ANSI/
AAMI/ISO/EN 11138-1 and USP where applicable.Namsa
Namsa's wide range of sterilization monitoring products is used by medical device and pharmaceutical manufacturers, contract sterilizers, and other science laboratories. Their products include;
Biological Indicators - SPORTROL ® biological indicators for steam, ethylene oxide, dry heat, gamma and E-beam radiation sterilization, , and Customised BI’s to meet specific end user requirements
Chemical Indicators – Process Indicator labels for steam, ethylene oxide, dry heat, gamma and E-beam radiation sterilization
Growth Promotion Suspensions – Ready to use microbial suspensions that meet the USP requirements for media validation.
All Namsa products require minimal user training, are manufactured in ISO 13485 certified facilities and meet domestic and international standards
Biological Indicators
Strips and Discs
Used to evaluate the effectiveness of sterilization processes
Essential in performing sterilization cycle validation
For ethylene oxide gas, dry heat, steam and radiation sterilization
Wide range of organisms, populations and packaging
Spore strips, discs, suspensions and custom configurations
Meets AAMI, EN866, USP and ISO 11138 standards
NAMSA follows strict scientific procedures to prepare spore suspensions of certified population and resistance. These spores are then inoculated onto paper strips or discs. The strips (6mm x 30mm) are individually enclosed within glassine envelopes in shelf packs of 100 strips. Mini strips (2 mm x 10 mm) will fit into small areas of a device where a standard-sized spore strip cannot be used, such as within as syringe barrel, inside tubing or under a cap.
All spore strips are packaged in glassine envelopes. Discs are packaged in bulk without glassine envelopes in shelf packs of 100. Most species are available in populations from 104 to 107 (other populations are available upon request*).
NAMSA's SPORTROL Spore Suspensions are pure suspensions of viable spores for specific organisms of known resistance to various sterilization processes. They are suspended in water for injection and provided in 10 mL pharmaceutical vials.
Most species are available in populations of 103 to 108 spores per 0.1 mL (other populations are available upon request*).
Technical Specifications for Spore Strips and Suspensions (18-month shelf-life)
(Strips denoted by Code STX, Suspensions denoted by Code SUX)
Bacillus pumilus (Radiation)
Geobacillus stearothermophilus (Steam)
Bacillus atrophaeus (EtO/Dry Heat)
Spore Population per BI
N/a* / SUP-03
N/a* / SUS-03
N/a* / SUN-03
103 (1,000)
N/a* / SUP-04
STS-04 / SUS-04
STN-04 / SUN-04
104 (10,000)
N/a* / SUP-05
STS-05 / SUS-05
STN-05 / SUN-05
105 (100,000)
STP-06 / SUP-06
STS-06 / SUS-06
STN-06 / SUN-06
106 (1,000,000)
STP-07 / SUP-07
STS-062**
STN-062**
106 (1,000,000)
STP-08 / SUP-08
N/a* / SUS-07
N/a* / SUN-07
107 (10,000,000)
N/a* / SUN-078
108 (100,000,000)
Steam BI Data Sheet, Geobacillus stearothermophilus: Strips (STS) or Suspensions (SUS)
Radiation BI Data Sheet, Bacillus pumilus: Strips (STP) or Suspensions (SUP)
Dry Heat/EtO BI Data Sheet, Bacillus atropheus: Strips (STN) or Suspensions (SUN)
Dry Heat/EtO BI Data Sheet, Bacillus subtilis: Suspensions (SBS)
For the BI strips, Spores are inoculated on paper strips, packaged in individual glassine envelopes in packages of 100. We can also accommodate your specific needs by supplying strips in bulk without glassine envelopes (STX-062B)
*Other populations available upon request.
** Smaller-sized spore strip (2mm x 10 mm). Standard size is approximately 6 mm x 30 firm.
Spore Discs, Combination Spore Strips and Graded Population Test Kits*(18-month shelf-life)
DN-06
106 per 1/4-inch disc Bacillus atrophaeus
DN18-06
106 per 1/8-inch disc Bacillus atrophaeus
DS-06
106 per 1/4-inch disc Geobacillus stearothermophilus
DS18-06
106 per 1/8-inch disc Geobacillus stearothermophilus
STNS-65
Bacillus atrophaeus 106 and Geobacillus stearothermophilus 105 (for dry heat, steam or ethylene oxide). Spores are inoculated onto paper strips, packaged in individual glassine envelopes.
Spores are inoculated onto paper discs, either 1/4-inch or 1/8-inch in diameter, packaged in bulk without glassine envelopes
Custom Biological Indicators
NAMSA can manufacture customize BI strips eg. Wire or thread BI’s, discs and other configurations to meet your specifications or private label production. We also can provide biological indicators with alternative organisms and populations.
Namsa Spore Ampoules
Namsa offers Geobacillus stearothermophilus spore ampoules for use in steam sterilization processes which are ideal for use in validation of liquid and non liquid sterilization cycles. No activation is required; simply expose to sterilization process and incubate. For further information, click on the following;
Spore Ampoules Data Sheet
Namsa Self-Contained BI’s
NAMSA offers Self-Contained Biological Indicators (SCBI) for monitoring steam (spore population = 105 and 106) and Ethylene Oxide (population 106) sterilization 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.
NAMSA SCBIs are offered in boxes of 50 units. SCBIs are certified for species, population, purity, resistance (dvalue, z-value, where applicable) and expiration date.
SCS-05 Geobacillus stearothermophilus (Steam)
SCS-06 Geobacillus stearothermophilus (Steam)
SCE-06 Geobacillus stearothermophilus (EO)
Only minimal training is required to use SPORTROL Biological Indicators. For Namsa Test Methods or Material Safety Data Sheets please contact info@astechireland.ie where we can supply you with the following information;
Population Verification D-Value Testing Culturing Methods
Material Safety Data Sheets
Alternatively, processed or exposed biological indicators may be returned to NAMSA for testing.
Chemical Indicators
NAMSA's Chemical Process Indicators are self-adhesive labels suitable for application by hand or Meto gun on shipping cartons or individual packages. The label color indicates at a glance whether or not the product has gone through the sterilization process, making it easy for sterilization facilities and manufacturers to control inventory and assure end users that products have been exposed to the sterilization process.
Storage Considerations - All Indicator Types
Short-term, moderate heat (up to 35°C) or humid environmental conditions will not adversely affect the indicators' unexposed color. Storage in a cool, dry place at room temperature is recommended. Indicators should not be exposed to prolonged UV light, direct or indirect sunlight. After exposure to the sterilization process, NAMSA Chemical Process Indicators are stable.
For information on Gamma radiation labels, EtO, steam or vapour hydrogen peroxide chemical indicator labels.
Chemical Indicator Data Sheet
Custom Labels
Custom indicator labels are a convenient, cost-effective option for manufacturers who wish to combine a sterilization indicator with an existing label. These custom indicators can be any size or shape, in roll or sheet formats, and are designed for application directly to an existing label, pouch, carton, or other container as required. NAMSA currently manufactures custom labels for leading companies in the medical device, garments, food and packaging industries. Contact NAMSA for more information or a price quote on custom label configurations.
Customised Label Data Sheet
Sterilization Process Indicator inks
Flexographic/Gravure Inks can be used on labels, strips, films, papers, pouches, tapes and lid stock materials to monitor exposure to ethylene oxide, steam, hydrogen peroxide, dry heat, chemiclave, steam-formaldehyde and combination EO/steam. Silkscreen inks for steam are also available.
To obtain pricing and further information on the Namsa Range of Products please contact info@astechireland.ie.
Growth Promotion Suspensions
Growth Promotion Test Suspensions provide a quality control challenge to each batch or lot of medium, ensuring its growth promoting qualities, whether it is prepared from basic ingredients or purchased commercially prepared. Simply inoculate each batch or lot of medium and incubate under the appropriate growth conditions. Visible growth after incubation indicates the culture media is conducive to organism growth.
Product Specifications and Applications
NAMSA Growth Promotion Test Suspensions are ready-to-use microbial suspensions that meet the United States Pharmacopeia (USP) requirements for media performance testing. All suspensions comply with the USP <71> requirement for a population of <100 colony forming units (CFU) and are guaranteed to be within five passages of an original ATCC stock culture. All Growth Promotion Test Suspensions are provided as pure cultures in 2.5ml or 10 ml vials containing 25 or 100 doses (0.1ml each).
For More Information on the Growth Promotion Suspensions, click on the following;
Growth Promotion Suspension Data Sheets
Growth Promotion Material Safety Data Sheets
Population Verification Test Methodology
To obtain pricing and further information on the Namsa Range of Products please contact info@astechireland.ie.
Sporeview Bac Stear spore strips
€311.00
SKU: BS-106
Pack of 100 Strips
Lead time 1 to 2 weeks from receipt of order
Price: €311.00