Consistent.
Reliable.
Innovative.
Your most trusted
partner for sterilization
products and
services.
Monitoring Products for Steam Sterilization
NAMSA’s Sterilization Products Division manufactures
and markets a wide range of high quality Sterilization
Monitoring Products used globally. Our domestic and
international market segments include pharmaceutical,
medical device, contract sterilizers, laboratories, health
care, dental, food and beverage, and biotech companies.
NAMSA is a proud manufacturer and distributor of a
full line of Sterilization Monitoring Products including:
• Biological Indicators
• Chemical Process Indicators
• Chemical Indicating Inks
• Custom Indicator Labels
• Quality Control Test Suspensions
• Spore Suspensions
• Culture Media
• Incubators
Our products are tailored to suit many different sterilization processes including:
Table of Contents
Biological Indicators
Self-Contained Biological Indicators.................................3
• Traditional SCBIs
• Mini SCBIs
Spore Ampoules……………………………………...……..4
• 1 mL Spore Ampoules and Negative Controls
• 0.4 mL Mini Spore Ampoules
Incubators.............…………………………………………..5
Prepared Culture Media...…………………………………..5
Inoculated Carriers & Biological Indicators...……………..6
• Traditional Spore Strips
• Mini Spore Strips
• Dual Species Spore Strips
• Spore Discs
• Spore Threads & Spore Wires
•
Steam
• IRRAD
Irradiation
Spore Suspensions.............………………………........…..8
• VH202
Vaporized Hydrogen Peroxide/Plasma
Chemical Indicators
•
Ethylene Oxide
• DRY
Dry Heat
• FORM
Formaldehyde
•
Chlorine Dioxide
CL02
Chemical Process Indicators............................................9
Chemical Indicators, Integrators
& Emulators............………………………........….............10
• Chemical Indicators - Class 4
• Chemical Integrator - Class 5
• Chemical Emulator - Class 6
Bowie & Dick Test Packs..................................................11
NAMSA’s sterilization products are manufactured in
an FDA regulated facility certified to ISO 13485:2003.
Globally NAMSA maintains a comprehensive list of
accreditations and certifications. Please visit www.
NAMSA.com to learn more.
Visit our webpage at www.NAMSA.com/Products
Call us at 419-662-4345 (outside the U.S.) and
800-860-1888 (toll-free)
Fax us at 419-666-1715
Email us at productorders@namsa.com
World Headquarters
6750 Wales Road
Northwood, Ohio 43619 USA
Indicator Tape.................................................................. 11
Biological Indicators
Self-Contained Biological Indicators
NAMSA Self-Contained Biological Indicators (SCBIs) for monitoring steam sterilization processes provide fast, visible,
consistent and reliable results offering peace of mind for assurance of effective steam sterilization processing. Use of
NAMSA’s SCBIs reduces the possibility of contamination and minimizes the potential for false positives associated with
post-exposure transfer.
• Reduced incubation time of 24 hours
• Visually distinct positive results from Purple to Yellow
• Chemical Indicator on label provides instant indication of exposure
• Saves time by eliminating aseptic culturing required with traditional spore strips
• Unique packaging insert keeps SCBIs in upright position and allows for quick reference to the number of units remaining
in the package
• Compliant with ISO 11138-1 and 11138-3
Mini SCBIs
Traditional SCBIs
Consist of a durable polycarbonate vial with cap, a crushable glass ampoule with an exclusively formulated Tryptic
Soy Broth (TSB) modified with pH indicator, and a disc
inoculated with Geobacillus stearothermophilus spores.
• Heavy duty construction allows for exposures
under extreme conditions without concern of
causing damage to the SCBI
• Activate for incubation by pressing the smart
push cap system completely to crush the ampoule
• Larger size, 13 mm x 61 mm, fits directly into
autoclave racks/baskets
Consist of a thermoplastic vial and a purple cap, a crushable
glass ampoule with an exclusively formulated Tryptic
Soy Broth (TSB) modified with pH indicator, and a disc
inoculated with Geobacillus stearothermophilus spores.
• The Mini SCBIs are easily activated by squeezing
the sides of the vial manually or with a convenient
crushing tool
• Smaller size, 9 mm x 50 mm, designed to fit in
challenging sterilization areas
Traditional SCBIs
Mini SCBIs
Geobacillus stearothermophilus Cell Line 7953
24 month shelf-life
Geobacillus stearothermophilus Cell Line 7953
24 month shelf-life
NAMSA Code Population
SCS-05
SCS-06
105
106
Incubation Time
Quantity
NAMSA Code Population
24 hours
24 hours
50/box
50/box
MSCS-05
MSCS-06
105
106
Incubation Time
Quantity
24 hours
24 hours
100/box
100/box
3
Biological Indicators
Spore Ampoules
NAMSA Spore Ampoules are ideal for use in validation and routine monitoring of liquid steam sterilization cycles. Spore
Ampoules are manufactured using hermetically sealed Type I borosilicate glass containing an exclusively formulated Tryptic
Soy Broth (TSB) modified with pH indicator, and Geobacillus stearothermophilus spores. No activation is required; simply
expose Spore Ampoules to sterilization process and incubate.
• Reduced incubation time of 48 hours
• Clear visible results as growth is evident by turbidity and/or a color shift of the media from Purple to Yellow
• Saves time by eliminating aseptic culturing required with traditional spore strips
• Unique packaging insert keeps Ampoules in upright position and allows for quick reference to the number of units
remaining
• Each shipment is accompanied by a Certificate of Analysis and Instructions for Use
• Storage under refrigerated conditions (2°C to 8°C) is required. Do not freeze Spore Ampoules
• Compliant with ISO 11138-1 and 11138-3
1 mL Spore Ampoules
• Spore Ampoules are 58 mm in length and 10.8 mm
in diameter
• Each snap top ampoule is imprinted with lot number
• Negative Controls (SA1-NC-10) are available in
convenient packages of 10 per box
0.4 mL Mini Spore Ampoules
• Mini Spore Ampoules are 32 mm in length and
6.4 mm in diameter
• Small size allows for
placement in areas
where the larger 1 mL
ampoule will not fit
• Mini Ampoules are
sold in kits which
include negative
controls
0.4 mL Mini Spore Ampoules
1 mL Spore Ampoules
Geobacillus stearothermophilus Cell Line 7953
24 month shelf-life
Geobacillus stearothermophilus Cell Line 7953
24 month shelf-life
NAMSA Code
Population
OS1-50-06
10 6
Volume
Quantity
NAMSA Code
Population
0.4 mL
50/box + 5
negative controls
SA1-15-04
SA1-50-04
SA1-15-05
SA1-50-05
SA1-15-06
SA1-50-06
10
104
105
105
106
106
4
Volume
1 mL
1 mL
1 mL
1 mL
1 mL
1 mL
Quantity
15/box
50/box
15/box
50/box
15/box
50/box
1 mL Negative Control Ampoules
24 month shelf-life
NAMSA Code
SA1-NC-10
4
Volume
Quantity
1 mL
10/box
Biological Indicators
Incubator
The NAMSA Incubator is designed for convenient and reliable incubation of NAMSA’s SCBIs
including 1 mL Spore Ampoules.
• The electronically-heated aluminum block holds up to 10 units
• Well size: 13 mm
• Temperature and incubation time are displayed digitally
• Adjustable temperature (5°C to 70°C) and incubation time (0 to 99h 59m)
• In 15 minutes or less, the incubator will reach the set
point temperature up to 70°C
• Transparent cover included to ensure consistent temIncubator
perature and to protect the units
• Universal 110-220V power supply
NAMSA Code
Plug Configuration
• See table to the right for standard cord/plug options.
INC-13A
North & South America, 110-220V
Please inquire for other options not listed
INC-13E
Europe, 110-220V
• 12 month limited warranty
INC-13U
United Kingdom, 110-220V
INC-13AC
Australia & China, 110-220V
Prepared Culture Media
NAMSA’s Prepared Culture Media consists of an exclusively formulated Tryptic Soy Broth (TSB) modified with pH indicator. A reduced incubation time of 24 hours for steam sterilization has been validated when NAMSA Biological Indicator
Spore Strips and Discs are used in conjunction with NAMSA’s Prepared Culture Media.
• Reduced incubation time of 24 hours
• Visually distinct results from Purple to Yellow
• 16 mm x 100 mm flat bottom tubes of Type I
borosilicate glass with screw caps
• Each lot is accompanied by a Certificate of Analysis
and is certified with growth promotion capabilities
using Geobacillus stearothermophilus Cell Line 7953
Prepared Culture Media
12 month shelf-life
NAMSA Code
Volume
Quantity
GMBCP-100
4 mL
100 tubes/box
5
Biological Indicators
Inoculated Carriers & Biological Indicators
NAMSA manufactures a full line of Inoculated Carriers and Biological Indicators (BIs) for use in monitoring steam sterilization
processes. Our most popular inoculated carriers and biological indicators are manufactured using state of the art equipment,
which provides assurance that each glassine pouch contains a biological indicator consistent in population, purity and dimension.
• Convenient shelf packages of 100 units per box
• Room temperature storage conditions (15°C to 30°C), relative humidity of 30% to 80% is recommended
• Products are accompanied by a Certificate of Analysis and are certified with population, purity, and resistance characteristics
(D-value, z-value, survival and kill where applicable)
• Compliant with ISO 11138-1 and 11138-3
Traditional Spore Strips
Consist of inoculated filter paper, each 6 mm x 30 mm,
individually packaged in easy-to-handle glassine pouches.
• The strips can be easily removed from the glassine
pouch by tearing or peeling the pouch open for transfer
to culture media or challenge device assembly
• NAMSA offers both Geobacillus stearothermophilus for
monitoring processes of 121°C and higher and Bacillus
subtilis strips for monitoring low temperature steam
sterilization processes
Mini Spore Strips
Consist of inoculated filter paper, each 2 mm x 10 mm,
packaged in a variety of options. The small size of the Mini
Spore Strips allows them to fit into areas of a device where
standard sized spore strips cannot be used, such as within a
syringe barrel, inside tubing or under a cap.
• NAMSA Mini Spore Strips are available packaged in
glassine envelopes of two sizes: a larger envelope 25
mm x 50 mm (STS-062) or a mini glassine envelope 25
mm x 25 mm (STS-062MG)
• The product is also available as an inoculated carrier in
bulk (no glassine packaging)(STS-062B)
• Population levels other than 106 are available upon request
Traditional Spore Strips
Geobacillus stearothermophilus Cell Line 7953
24 month shelf-life
NAMSA Code
Population
Quantity
STS-04
10
STS-05
105
STS-06
106
Bacillus subtilis Cell Line 5230
15 month shelf-life
100/box
NAMSA Code
Quantity
BS52306
4
Population
100/box
100/box
106 100/box
Dual Species Spore Strips
Geobacillus stearothermophilus Cell Line 7953 and
Bacillus atrophaeus Cell Line 9372
24 month shelf-life
NAMSA Code
STNS-65
6
Population
105 Geobacillus stearothermophilus
106 Bacillus atrophaeus
Quantity
100/box
Mini Spore Strips
Geobacillus stearothermophilus Cell Line 7953
24 month shelf-life
NAMSA Code
Packaging
Population
Quantity
STS-062
Glassine envelopes
6
10
100/box
STS-062B
Bulk
10
6
100/box
10
100/box
STS-062MG Mini-glassine
envelopes
6
Biological Indicators
Spore Discs
NAMSA Spore Discs are available in two different sizes, 3 mm and 6 mm diameters. The discs are designed to be utilized
as an inoculated carrier for placement directly into areas of a device which are the most difficult to sterilize.
• The Inoculated Carriers are packaged in easy-to-access and handle bulk packaging
• NAMSA Spore Discs will fit into small areas of a device where a standard-sized spore strip
cannot be used, such as within a syringe barrel, inside tubing and vials or under a cap
6 mm
3 mm
Spore Discs
Geobacillus stearothermophilus Cell Line 7953
24 month shelf-life
NAMSA Code
Disc Diameter
DS-06
DS18-06
6 mm
Packaging Population
Quantity
Bulk Bulk
106
106
100/box
100/box
6 mm
3 mm
3 mm
Spore Threads & Spore Wires
• Ideal for use in tubing, lumens and other devices/instruments where
larger BIs and carriers cannot be utilized
• NAMSA’s manufacturing process is designed to ensure that the entire
length of the threads and wires contains a consistent number of spores
• Spore Wires have a rigid structure which allows for easy insertion and removal from a device
• The steel construction in our Spore Wires does not absorb moisture which is ideal when there is condensation within
the lumen
• Compliant with ISO 11138-1
Spore Threads & Spore Wires
Geobacillus stearothermophilus Cell Line 7953
24 month shelf-life (Threads) / 12 month shelf-life (Wires)
NAMSA Code
Description
Packaging
Population
Quantity
THS-05
Cotton Thread
25 mm x 0.1 mm
Bulk 105
100/box
THS-06
Cotton Thread
25 mm x 0.1 mm
Bulk 106
100/box
SWS-06
Braided Steel
40 mm x 1.5 mm
Bulk 106
100/box
Spore Strips, Spore Discs, Spore Wires and Spore Threads can be customized to meet your needs with population levels
of 102 to 107. Please contact us for more information.
7
Biological Indicators
Spore Suspensions
NAMSA manufactures a wide range of Spore Suspensions utilized in steam sterilization processes. The Spore Suspensions are pure suspensions of spores with known steam resistance characteristics and a variety of population levels
standardized per 0.1 mL. The Spore Suspensions allow for direct inoculation of products, typically to verify sterility of
devices where a traditional biological indicator spore strip cannot be used. They can also be used for a variety of other
microbiological tests including cleaning effectiveness studies, Bioburden percent recovery and Bacteriostasis/Fungistasis
(BF) testing.
• Pharmaceutical grade glass vials with screw cap and septum
• Convenient vials of 10 mL volumes suspended in
Water for Injection (WFI)
• A variety of organisms including Geobacillus stearothermophilus and Bacillus subtilis (Cell Lines 6633 and
5230) for low temperature processes (<121°C)
• Spore Suspensions require storage under refrigerated
conditions (2°C to 8°C)
• Each vial of Spore Suspension is accompanied by a
Certificate of Analysis detailing the source, assayed
population, resistance characteristics on paper carrier
and expiration date
• ISO 11138-1 compliant
Spore Suspensions
Geobacillus stearothermophilus Cell Line 7953
24 month shelf-life
NAMSA Code
Population per 0.1 mL
SUS-02
SUS-03
SUS-04
SUS-05
SUS-06
SUS-07
SUS-08
102
103
104
105
106
107
108
Bacillus subtilis Cell Line 5230
15 month shelf-life
NAMSA Code
Population per 0.1 mL
US52304
US52305
US52306
US52307
US52308
104
105
106
107
108
Bacillus subtilis Cell Line 6633
14 month shelf-life
NAMSA Code
SBS-04
SBS-05
SBS-06
SBS-07
SBS-08
8
Population per 0.1 mL
104
105
106
107
108
Chemical Indicators
Chemical Process Indicators
NAMSA Steam Chemical Process Indicators (CPIs) are manufactured with NAMSA’s Eco Friendly Indicating Inks and meet
performance specifications as outlined in ISO 11140-1 Sterilization of health care products - Chemical indicators Part 1: General requirements, for Class 1 Process Indicators. Our Chemical Process Indicators provide a fast and consistent visual check on items that were sterilized by steam.
• Consistent and irreversible color transition from Blue to Pink
• No light sensitivity issues
• Permanent pressure-sensitive adhesive
• 24 month shelf-life
• Room temperature storage (15°C to 30°C)
• Each shipment is accompanied by a Certificate of Conformance to ensure product quality and consistency
Chemical Process Indicators
24 month shelf-life
NAMSA Code Description
CPI-S01
Plain 12.7 mm Dots
SP-S05
Label with Indicator
64 mm x 38 mm
Indicators Per Roll
Unexposed
Exposed
5,000
1,000
Ask us about NAMSA’s custom sterilization indicator program.
Colors shown are representations of printed ink initial and signal colors but may vary from actual use.
NAMSA Eco
Friendly Inks
All of NAMSA’s Chemical Process Indicator Products are manufactured
utilizing NAMSA’s technologically advanced Eco Friendly Indicating Inks.
It is our guarantee to nature that all of our chemical indicating inks
contain no lead or other toxic heavy metals and have minimal
levels of Volatile Organic Compounds (VOCs).
9
Chemical Indicators
Chemical Indicators, Integrators and Emulators
NAMSA is introducing a new generation of Chemical Indicators, Integrators and Emulators manufactured with
NAMSA’s Eco Friendly Indicating Ink technology and tear resistant lamination protection. Our new innovative indicators
demonstrate exceptional performance and are customized for the most widely utilized steam sterilization processes.
NAMSA evaluates the performance of every lot of Chemical Indicators, Integrators and Emulators in state of the art
equipment to ensure consistent and reliable performance.
• Lead & latex free
• Distinct color change will not revert
• Long shelf life of 24 months
• Each shipment includes a Certificate of Conformance for assurance of product quality and performance
• Room temperature storage (15°C to 30°C)
Before Exposure
Chemical Indicator – Class 4
• Irreversible color transition from
Yellow to Dark (dark brown/black)
• Designed for Class 1 use at
exposures at 121°C and higher
• Class 4 exposures at 121°C for 10
minutes or 134°C for 2.5 minutes
After Exposure
• ISO 11140-1 Class 4 Compliant
Before
Chemical Integrator – Class 5
Exposure
• Irreversible color transition from Green to Yellow/Tan
• Class 5 exposures at 121°C for 16.5 minutes or
134°C for 3.5 minutes
After
• ISO 11140-1 Class 5 Compliant
Exposure
Before
Exposure
Chemical Emulator – Class 6
• Irreversible color transition from Blue to Pink
• Class 6 exposures at 134°C for 3.5 minutes
• ISO 11140-1 Class 6 Compliant
After
Exposure
Chemical Indicators, Integrators and Emulators
24 month shelf-life
NAMSA Code
TST4S-250
TST5S-250
TST6S-250
Description
Class 4 Indicator
Class 5 Integrator
Class 6 Emulator
Dimensions
115 mm x 19 mm 76 mm x 19 mm 76 mm x 19 mm
Quantity
250/box
250/box
250/box
Ask us about NAMSA’s custom sterilization indicator program.
Colors shown are representations of printed ink initial and signal colors but may vary from actual use.
10
Chemical Indicators
Bowie & Dick Test Packs
NAMSA Bowie & Dick Test Pack evaluates the efficacy of
air removal and steam penetration in pre-vacuum sterilizers.
A Bowie & Dick Test Pass result indicates that the sterilizer
successfully removes air and allows steam to penetrate
loads placed in the chamber. NAMSA Bowie & Dick Test
Packs consist of a series of steam penetration barriers in the
center of which is a chemical indicator sheet manufactured
using NAMSA’s Eco Friendly Indicating Ink.
• Single use, biodegradable and latex free
• Barrier material made from 99% recycled paper
• Irreversible color transition
• Durable, easy-to-handle construction
• Does not retain heat
• Convenient exterior Chemical Process Indicator allows
for easy verification of processed from unprocessed
test packs
• No preferential route of steam entry; can be placed
either way in autoclave
• Designed for use in European type load configurations
• ISO 11140-4 compliant
Bowie & Dick Test Packs
48 month shelf-life
NAMSA Code
BD-1XCS
Dimensions
L:13 cm x W:12.40 cm x H:2.85 cm
Quantity
20/box
Indicator Tape
NAMSA Steam Tape is Class 4 compliant. Our autoclave
tape consists of a strong crepe-embossed paper with a
pressure sensitive adhesive. The Steam Tape adheres to
paper, paper/plastic, woven, treated woven and non-woven
wraps. The adhesive allows for secure seals yet is easy to
remove. The Steam Tape is manufactured with NAMSA’s
Eco Friendly Inks making it one of the most environmentally friendly and most consistently performing steam
tapes on the market. Designed to aid in distinguishing
processed from unprocessed loads.
• Lead & natural rubber latex free
• Irreversible color transition from Green to Orange
• Can be written upon
• Long shelf-life of 24 months
• ISO 11140-1 Class 4 Compliant
Indicator Tape
Before Exposure
24 month shelf-life
NAMSA Code
TAP-S48
Width
18 mm
Length/Roll
Core Diameter
55 m
7.62 cm
Quantity
48 rolls/box
After Exposure
11
Our Product Literature
Consistent.
Reliable.
Innovative.
Timely.
Accurate.
Experienced.
Your most trusted
partner for sterilization
products and
services.
We’re with you
from start to finish.
Monitoring Products for Steam Sterilization
Monitoring Products for Ethylene Oxide
Trusted.
Tailored.
Precise.
We can help you
ensure the safety
of your product.
Monitoring Products for Gamma & E-Beam Sterilization
IRRAD
Innovative.
Smart.
Trusted.
Secure.
Tested.
Certified.
Precise.
User-friendly.
Flexible.
We’re your partner for
sterilization products.
We solve problems
with confidence
and creativity.
We’re here to verify your
product performance.
Monitoring Products for Dry Heat
Monitoring Products for Vaporized Hydrogen Peroxide
VH202
VH202
DRY
Formaldehyde
FORM
Chlorine Dioxide
DRY
FORM
CL02
CL02
Distributed by:
Validated.
Accurate.
Trustworthy.
NAMSA,the pioneers
who still lead the
field.
Sterilization Process Indicator Inks
INKS
INKS
North American Science Associates, Inc. © 2014; Printed in the USA. 10/14
STEAM REV1
Quality Control Test Suspensions - Growth Promotion
IRRAD