Consistent. Reliable. Innovative.

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1 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.

2 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: Steam IRRAD Irradiation VH202 Vaporized Hydrogen Peroxide/Plasma Ethylene Oxide DRY Dry Heat FORM Formaldehyde CL02 Chlorine Dioxide 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. Table of Contents Biological Indicators Self-Contained Biological Indicators...3 Traditional SCBIs Mini SCBIs Spore Ampoules ml Spore Ampoules and Negative Controls 0.4 ml Mini Spore Ampoules Incubators Prepared Culture Media Inoculated Carriers & Biological Indicators Traditional Spore Strips Mini Spore Strips Dual Species Spore Strips Spore Discs Spore Threads & Spore Wires Spore Suspensions Chemical Indicators Chemical Process Indicators...9 Chemical Indicators, Integrators & Emulators Chemical Indicators - Class 4 Chemical Integrator - Class 5 Chemical Emulator - Class 6 Bowie & Dick Test Packs...11 Indicator Tape Visit our webpage at Call us at (outside the U.S.) and (toll-free) Fax us at us at productorders@namsa.com World Headquarters 6750 Wales Road Northwood, Ohio USA

Self-Contained Biological Indicators Biological Indicators NAMSA Self-Contained Biological Indicators (SCBIs) for monitoring steam sterilization processes provide fast, visible, consistent and

Use of NAMSA s SCBIs reduces the possibility of contamination and minimizes the potential for false positives associated with post-exposure transfer.

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

3 Self-Contained Biological Indicators 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 and 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 Mini SCBIs 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 NAMSA Code Population Incubation Time Quantity SCS hours 50/box SCS hours 50/box Mini SCBIs NAMSA Code Population Incubation Time Quantity MSCS hours 100/box MSCS hours 100/box 3

Biological Indicators Spore Ampoules NAMSA Spore Ampoules are ideal for use in validation and routine monitoring of liquid steam sterilization cycles.

stearothermophilus spores. No activation is required; simply expose Spore Ampoules to sterilization process and incubate.

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

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.

4 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 and 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 NAMSA Code Population Volume Quantity OS ml 50/box + 5 negative controls 1 ml Spore Ampoules NAMSA Code Population Volume Quantity SA ml 15/box SA ml 50/box SA ml 15/box SA ml 50/box SA ml 15/box SA ml 50/box 1 ml Negative Control Ampoules NAMSA Code Volume Quantity SA1-NC-10 1 ml 10/box 4

Biological Indicators Incubator The NAMSA Incubator is designed for convenient and reliable incubation of NAMSA s SCBIs including 1 ml Spore Ampoules.

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 temperature and to protect the units Universal 110-220V

5 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 temperature and to protect the units Universal V power supply See table to the right for standard cord/plug options. Please inquire for other options not listed 12 month limited warranty Incubator NAMSA Code Plug Configuration INC-13A North & South America, V INC-13E Europe, V INC-13U United Kingdom, V INC-13AC Australia & China, V 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 Prepared Culture Media 12 month shelf-life NAMSA Code Volume Quantity GMBCP 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

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

6 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 and 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 10 6 are available upon request Traditional Spore Strips NAMSA Code Population Quantity STS /box STS /box STS /box Bacillus subtilis Cell Line month shelf-life NAMSA Code Population Quantity BS /box Mini Spore Strips NAMSA Code Packaging Population Quantity STS-062 Glassine envelopes /box STS-062B Bulk /box STS-062MG Mini-glassine /box envelopes Dual Species Spore Strips and Bacillus atrophaeus Cell Line 9372 NAMSA Code Population Quantity STNS Geobacillus stearothermophilus 10 6 Bacillus atrophaeus 100/box 6

Spore Discs Biological Indicators NAMSA Spore Discs are available in two different sizes, 3 mm and 6 mm diameters.

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

100/box 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

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 (Threads) / 12 month

7 Spore Discs Biological Indicators 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 NAMSA Code Disc Diameter Packaging Population Quantity 6 mm DS-06 6 mm Bulk /box DS mm Bulk /box 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 Spore Threads & Spore Wires (Threads) / 12 month shelf-life (Wires) NAMSA Code Description Packaging Population Quantity THS-05 Cotton Thread Bulk /box 25 mm x 0.1 mm THS-06 Cotton Thread Bulk /box 25 mm x 0.1 mm SWS-06 Braided Steel Bulk /box 40 mm x 1.5 mm Spore Strips, Spore Discs, Spore Wires and Spore Threads can be customized to meet your needs with population levels of 10 2 to Please contact us for more information. 7

8 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 compliant Spore Suspensions NAMSA Code Population per 0.1 ml SUS SUS SUS SUS SUS SUS SUS Bacillus subtilis Cell Line month shelf-life NAMSA Code Population per 0.1 ml US US US US US Bacillus subtilis Cell Line month shelf-life NAMSA Code Population per 0.1 ml SBS SBS SBS SBS SBS

Chemical Process Indicators NAMSA Steam Chemical Process Indicators (CPIs) are manufactured with NAMSA s Eco Friendly Indicating Inks and meet performance specifications as

Our Chemical Process Indicators provide a fast and consistent visual check on items that were sterilized by steam.

shipment is accompanied by a Certificate of Conformance to ensure product quality and consistency Chemical Process Indicators Chemical Indicators NAMSA Code Description

7 mm Dots 5,000 SP-S05 Label with Indicator 1,000 64 mm x 38 mm Ask us about NAMSA s custom sterilization indicator program.

9 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 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 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 Chemical Indicators NAMSA Code Description Indicators Per Roll Unexposed Exposed CPI-S01 Plain 12.7 mm Dots 5,000 SP-S05 Label with Indicator 1, mm x 38 mm 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

Our new innovative indicators demonstrate exceptional performance and are customized for the most widely utilized steam sterilization processes.

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

higher Class 4 exposures at 121 C for 10 minutes or 134 C for 2.

10 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 ISO Class 4 Compliant After Exposure Before Exposure After Exposure Chemical Integrator Class 5 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 ISO Class 5 Compliant Chemical Emulator Class 6 Irreversible color transition from Blue to Pink Class 6 exposures at 134 C for 3.5 minutes ISO Class 6 Compliant Before Exposure After Exposure NAMSA Code Description Dimensions Quantity TST4S-250 Class 4 Indicator 115 mm x 19 mm 250/box TST5S-250 Class 5 Integrator 76 mm x 19 mm 250/box TST6S-250 Class 6 Emulator 76 mm x 19 mm 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, Integrators and Emulators

Chemical Indicators Bowie & Dick Test Packs NAMSA Bowie & Dick Test Pack evaluates the efficacy of air removal and steam penetration in pre-vacuum sterilizers.

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.

11 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 compliant Bowie & Dick Test Packs 48 month shelf-life NAMSA Code Dimensions Quantity BD-1XCS L:13 cm x W:12.40 cm x H:2.85 cm 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 Class 4 Compliant Indicator Tape Before Exposure NAMSA Code Width Length/Roll Core Diameter Quantity TAP-S48 18 mm 55 m 7.62 cm 48 rolls/box After Exposure 11

Our Product Literature Consistent. Reliable.

Your most trusted partner for sterilization

Monitoring Products for Ethylene Oxide Trusted.

We can help you ensure the safety of your product.

Sterilization IRRAD Innovative. Smart. Trusted.

We solve problems with confidence and creativity.

Monitoring Products for Dry Heat DRY Formaldehyde

Peroxide VH202 VH202 FORM Chlorine Dioxide DRY

12 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 DRY Formaldehyde Monitoring Products for Vaporized Hydrogen Peroxide VH202 VH202 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

Secure. Tested. Certified.

Secure. Tested. Certified. We solve problems with confidence and creativity. Monitoring Products for Dry Heat DRY Steam-Formaldehyde Chlorine Dioxide FORM CL02 NAMSA s Sterilization Products Division manufactures