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1 All products manufactured by Mesa are done so in accordance with current Quality System Regulations of the United States Food and Drug Administration and meet the standards established by USP and ISO Mesa s Quality System is registered to ISO 13485:2003 Standards. ( 주 ) 세현테크 TEL : FAX : Follow Mesa s ongoing BI relocation efforts by visiting 1 Effective January 9th, 2017 Rev

2 ProSpore Ampoule ProSpore Ampoule is a self-contained biological indicator for steam sterilization ideal for validating the sterilization of liquid loads, while also suitable for loads containing dry goods. No activation is required. Simply expose the unit to the sterilization process and incubate afterwards. ProSpore Ampoule is validated for 48-hour reduced incubation. ProSpore 4ml Self-contained glass ampoules for steam sterilization 510(k) received for use at 121 C for healthcare facilities May be used between C* Vivid purple to yellow color change ProSpore 1ml Intended for use with industrial steam sterilization processes between C Negative controls (NC) available Vivid purple to yellow color change Negative Controls The negative control is a media ampoule made from the same lot of media used to make the corresponding spore ampoules. Certification Each lot of ProSpore is certified for population, species, D-value, z-value, purity and expiry. Shelf life is 18 months from date of manufacture. ProSpore (log 5 and higher) comply with AAMI/ISO and AAMI/ISO * Industrial Use Only

3 ProSpore Ampoule Specifications ProSpore Ampoule is a hermetically sealed, type I borosilicate glass ampoule. The ampoule is filled with a modified Soybean Casein Digest Broth containing bromocresol purple acid indicator. Each ampoule also contains a population of G. stearothermophilus spores. ProSpore Ampoule (4 ml) has received 510(k) notification for sale to healthcare facilities with a 48-hour incubation period. Growth is evident by either turbidity and/or a color change from purple to or toward yellow. Expiration is 18 months from the date of manufacture. Ordering Information ProSpore Ampoule is a refrigerated item and requires overnight shipping. For pricing information, please see current price list. ProSpore 4ml Ampoule Outer Diameter: 14.75mm +/- 0.15mm Height: mm Species Catalog # Min. Population Qty/Box G. stearothermophilus PS x G. stearothermophilus PS x G. stearothermophilus PS x G. stearothermophilus PS x G. stearothermophilus PS x ProSpore 1ml Ampoule Outer Diameter: 10.75mm +/- 0.15mm Height: mm Species Catalog # Min. Population Qty/Box G. stearothermophilus PS x G. stearothermophilus PS x G. stearothermophilus PS x G. stearothermophilus PS x G. stearothermophilus PS x G. stearothermophilus PS x G. stearothermophilus PS1-5-60NC* 1.0 x NC G. stearothermophilus PS1-6-60NC* 1.0 x NC Rev

4 MagnaAmp Spore Strips and Culture Media MagnaAmp is a self-contained biological indicator ampoule for monitoring steam sterilization of liquids in containers or washer sterilizers. The MagnaAmp biological indicator ampoules contains Geobacillus stearothermophilus spores and a specially-formulated culture medium that turns a dramatic yellow if spores grow. The MagnaAmp provides easy visual confirmation of sterilization within 48-hours, without the need for difficult and time-consuming laboratory work. 48-hour results Small (1ml), conveniently shaped ampoule Designed to sink in container Negative controls are included with each box of product No laboratory required Dramatic color change Storage Refrigerate at 2-8 C. Certification MagnaAmp biological indicators are traceable to a recognized culture collection and certified for population, D-value, z-value, F o value and performance. Ordering Information Species Catalog # Min. Population Sets/Box G. stearothermophilus MA/5 1.0 x G. stearothermophilus MA/6 1.0 x Rev

5 Spore Strips Mesa Labs offers a complete line of spore strips for sterility testing in various sterilization environments for both Healthcare and Industrial applications. In addition to our line of spore strips, Mesa also manufactures prepared culture media specially formulated for use with our spore products. Other forumlations are also available for various microbiological tests. Autoclave Validations EO Sterilization Steam Applications Irradiation Sterilization Multiple Species Available Spore Strips Geobacillus stearothermophilus For use in steam sterilization at C (250 F) to 135 C (275 F), Low Temperature Steam w/formaldehyde and Chemiclave. After exposure to sterilant, incubate strips at C. 24-Hour incubation available when used with Mesa s Culture Media. Bacillus atrophaeus For use in Ethylene Oxide (600mg/L), Dry Heat sterilization (D-value determined at 160 C), and formaldehyde fumigation. After exposure to sterilant, incubate strips at C. Combined species spore strips G. stearothermophilus (10 5 ) and B. atrophaeus (10 6 ) on each strip. For use in Steam, EO, Dry Heat or Chemiclave sterilizers. In-house studies have shown the performance of dual species strips to be essentially equivalent to single species strips made from the same spore batch. Bacillus pumilus Used for validation of irradiation sterilization processes. After exposure to sterilant, incubate strips at C. Ordering Information Species Min. Population Log G. stearothermophilus 100, G. stearothermophilus 1,000, B. atrophaeus 1,000, B. pumilus 1,000, Reduced Incubation Available Contact us for more details. Rev

6 Culture Media Prepared Culture Media Soybean Casein Digest Broth is the recommended media (USP 24) for use with Biological Indicators. Use of another media may detrimentally affect outgrowth of spore. Mesa s TSB is manufactured and tested to meet USP and NCCLS sterility and growth promotion guidelines. It is also specially formulated for use with our spore products. Prepared Media is packaged in Type I borosilicate glass tubes with polypropylene screw-caps (white rubber liners). Available sizes: 13mm X 100mm, 16mm X 100mm, and 20mm X 100mm test tubes. Also available in 500ml and 1L screwcapped, pourable bottles. Other sizes available upon request. 24-Hour Incubation A reduced incubation time of 24 hours at 60 C +/- 2 C has been validated for steam sterilization when the Mesa Bacterial Spore Strip (either the single species G. stearothermophilus spore strip or the dual species spore strip) is used in conjunction with Mesa s (OMF) Modified Tryptic Soy Broth with Bromocresol Purple. 510k information available upon request. Culture Media Dehydrated Culture Media Mesa recommends Acumedia TSA and TSB for use in verifying the certified label claims for our products. Acumedia has an extensive line of high quality dehydrated culture media at affordable prices. Mesa uses Acumedia in-house for the manufacture and QC testing of our products. The entire Acumedia line is now available through Mesa Labs and many of our international distributors. Ordering Information Tryptic Soy Broth Catalog Number Fill Quantity Tube Size Tryptic Soy Broth TSB-C ml 100 / box 16mm x 100mm Tryptic Soy Broth w/phenol Red TSB-PR ml 100 / box 16mm x 100mm Tryptic Soy Broth w/bromocresol Purple TSB-BP ml 100 / box 16mm x 100mm Tryptic Soy Broth in Screw Capped Bottle TSB ml minimum purchase 10 bottles Rev

7 MesaStrip MesaStrip is a conventional paper strip biological indicator for monitoring steam, low temperature steam formaldehyde, ethylene oxide, dry heat, chlorine dioxide and gamma radiation industrial sterilization processes. MesaStrip contains bacterial spores on a filter paper carrier sealed within a convenient, peel-open glassine envelope. To use a MesaStrip, simply place the envelope inside a product or product package. This inoculated package is placed in a sterilizer and processed. Upon removal from the sterilizer, the inoculated package is sent to the microbiology laboratory for transfer of the MesaStrip. The BI is to be aseptically cultured in soybean casein digest medium and incubated at the appropriate temperature. Autoclave Validations EO Sterilization Steam Applications Irradiation Sterilization Multiple Species Available Storage Store at room temperature. Certification MesaStrip biological indicators are traceable to a recognized culture collection and certified for population, D-value, z-value (steam) and performance. Ordering Information Process Species Log Reorder # Steam G. stearothermophilus 10 5 SGMS/5 Steam G. stearothermophilus 10 6 SGMS/6 Low Temperature Steam B. subtilis (5230) 10 6 SGMSU/6 Ethylene Oxide and Dry Heat B. atrophaeus 10 6 SGMG/6 Gamma Radiation B. pumilus 10 6 SGMR/6 Chlorine Dioxide B. atrophaeus 10 6 ACD/6 Dual Species (Steam / EO and Dry Heat) G. stearothermophilus and B. atrophaeus 10 5 / 10 6 SGMD/ / 10 6 SGMD/66 Low Temp Steam Formaldehyde G. stearothermophilus 10 6 SGMLF/6 Rev

8 Custom Biological Indicators Custom Biological Indicators Most commercially available Biological Indicators are designed for healthcare applications and are not well suited for many manufacturing situations. Manufacturers and validation specialists require unique tools where spore strips and ampoules are not suitable because of size, packaging or carrier material. In addition to our line of Healthcare BIs, Mesa offers a line of Industrial Use BIs to address the unique requirements of the medical device and pharmaceutical industries. Bacillus Atrophaeus 2x10mm (A2X10/6) 1x25mm (A1X25/6) 6x6mm Carrier Part Number Use Population 1x25mm A1X25/6 Gas x10mm A2X10/6 Gas mm disc DA6R/6 Gas 10 6 Geobacillus Stearothermophilus Carrier Part Number Use Population 1x25mm S1X25/6 Steam x10mm S2X10/6 Steam mm disc DS6R/6 Steam 10 6 Rev

9 EZTest EZTest SCBI for Steam, EO, H2O2 and PPO EZTest is a self-contained biological indicator for monitoring steam, ethylene oxide, hydrogen peroxide, or propylene oxide sterilization. EZTest contains bacterial spores on a filter-paper carrier packaged within a small, thermoplastic culture tube. Inside the thermoplastic culture tube is a sealed-glass ampoule of specially-formulated soybean casein digest culture medium containing a color indicator which turns a dramatic yellow when spores grow. EZTest is easy-to-use and produces visual results within 24 hours (steam, hydrogen peroxide, or propylene oxide) or 48 hours (ethylene oxide) without laboratory transfers. FDA 510(k) notified (steam and EO) 24-hour results for steam, H2O2 or PPO 48-hour results for EO Easy to culture No laboratory required Dramatic color change Ordering Information EZTest for Steam / Flash Species Catalog # Min. Population Qty/Box G. stearothermophilus EZS/5 1.0 x G. stearothermophilus EZS/ x G. stearothermophilus EZS/6 1.0 x G. stearothermophilus EZS/ x EZTest for Ethylene Oxide Species Catalog # Min. Population Qty/Box B. atrophaeus EZG/6 1.0 x B. atrophaeus EZG/ x EZTest for Hydrogen Peroxide (H2O2) Species Catalog # Min. Population Qty/Box G. stearothermophilus EZH/5 1.0 x G. stearothermophilus EZH/6 1.0 x EZTest for Propylene Oxide (PPO) G. stearothermophilus EZP/5 1.0 x Rev

10 ExpoSure TM Biological Indicator ExpoSure TM Biological Indicator ExpoSure is a biological indicator intended for use in the STERRAD Sterilizer. ExpoSure has received its 510(k) making it suitable for healthcare and non-healthcare settings and usage. Its 24-hour incubation time and flexibility make it a powerful tool to help your facility maintain compliance and patient safety. ExpoSure is a direct replacement product and can be used in conjunction with existing incubators out in the field (55-60 C). The on-board chemical indicator confirms that it has been exposed to hydrogen peroxide by changing from red to blue upon exposure. Packaging: ExpoSure is packaged with 30 indicators per box along with 1 activation crusher. Reorder #: EXPO/6 Expiry: 12 months Approved Cycles: STERRAD 50 STERRAD 100S (Short & Long) STERRAD 200 (Short & Long) STERRAD NX (Advanced & Standard) STERRAD 100NX (STANDARD, FLEX, DUO, and EXPRESS) Incubation: 24 hours at C: Mesa offers its 1410 Dry Bath Incubator for use with ExpoSure Placement: Place the ExpoSure BI in a Tyvek pouch and place the pouch in the most challenging area for the sterilant to reach. This is typically on the shelf close to the rear of the sterilizer. Rev. 05DEC2016

11 ProTest for Steam, EO and H2O2 ProTest Self-Contained Biological Indicators for Steam, EO and H2O2 ProTest is a self-contained Biological Indicator for use in either Steam, Ethylene Oxide or H 2 O 2 sterilization. Each unit is made up of a plastic container with cap, a crushable glass ampoule with recovery media, and either a paper strip (for steam and EO) or borosilicate disc (for H 2 O 2 ) inoculated with spores. ProTest is available for healthcare and industrial use. ProTest Steam Intended for use in steam 121 C gravity displacement cycles, and C prevacuum cycles. (10 minute 132 C gravity displacement cycles, and 3 minute 132 C flash gravity displacement cycles.) 510(k) received for healthcare facilities Contains G. stearothermophilus spores 24-hour incubation Species Catalog # Min. Population Qty/Box G. stearothermophilus PT x G. stearothermophilus PT x G. stearothermophilus PT x G. stearothermophilus PT x ProTest EO Intended for use in Ethylene Oxide 600mg/L, 54 C, 60%RH 510(k) received for healthcare facilities Contains B. atrophaeus spores 48-hour incubation Species Catalog # Min. Population Qty/Box B. atrophaeus PT x B. atrophaeus PT x ProTest H2O2 Intended for use in the STERRAD Sterilization System 1 (Industrial Use Only). Contains G. stearothermophilus spores 24-hour incubation 1 Sterrad is a registered trademark of Advanced Sterilization Products. Species Catalog # Min. Population Qty/Box G. stearothermophilus PTH x G. stearothermophilus PTH x Certification Each lot of ProTest is certified for population, species, D-value, z-value (where applicable), purity and expiry. Shelf life is 18 months from the date of manufacture. The above catalog numbers for ProTest comply with AAMI/ISO and AAMI/ISO Rev

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14 Apex Discs - Triplicates Apex Discs - Triplicates Using BIs in Triplicate for VHP Processes Some sterilization processes, such as saturated steam under pressure with a pre-vacuum air removal, have great penetrative capabilities. The same is not true for ambient pressure gassing processes such as vapor phase hydrogen peroxide (VHP) at ambient pressures. Due to the limited penetrating capability of VHP, any presence of debris amongst the spores can also lead to spores surviving VHP exposures where kill was otherwise expected; a concept referred to as rogue BIs in various publications. Section 8.1 of PDA Technical Report No. 51 suggests that re-running the cycle with a different lot of BIs or re-running the cycle with duplicate or triplicate BIs in the same location may be necessary. The reason to use multiple BIs at each test location is because we need each BI to be a statistical replicate of its neighbor. Instead of monitoring 100 discrete locations throughout the isolator, the validation technician can identify the 30 or 40 most difficult to sterilize locations and use triplicate BIs at each of these challenge locations, thus consuming 90 or 120 BIs per cycle. When only one BI is used at each test location, and that one BI yields a growth-positive result, there is no way to calculate if that result was due to one surviving spore, or hundreds-of-thousands of surviving spores. Despite one growth-positive BI at a location of triplicate BIs, one can still document that a 6+ spore log reduction was achieved at that particular test location. Do be advised that this calculation is ONLY possible when replicate BIs are used. To find out more about how triplicate BIs are being used in VHP, click the link below to read the Spore News article on the subject. Packaged in Tyvek/Tyvek Discs measure 0.35 diameter x thick Tyvek packaged indicators have perforations for hanging and a thumb notch for peeling Available with reference #12980 or #7953 Catalog #HMV-091T Rev

15 Industrial Use Biological Indicators Most commercially available Biological Indicators are designed for healthcare applications and are not well suited for many manufacturing situations. Manufacturers and validation specialists require unique tools where spore strips and ampoules are not suitable because of size, packaging or carrier material. In addition to our line of Healthcare BIs, Mesa offers a line of Industrial Use BIs to address the unique requirements of the medical device and pharmaceutical industries. Woven Cotton Threads Length: 19mm Diameter: 1.5mm Threads have been used at the interface of a syringe and plunger to show sterilant penetration and efficacy at that point. Other uses include placement in tubing and small vials. Bio-threads are 100% cotton, 3/4 long-- and are inoculated with B. atrophaeus. The device/lumen into which the thread is inserted affects its resistance characteristics. Polyester Sutures Industrial Use Biological Indicators Length: 5cm Diameter: 0.15mm A polyester suture is desirable in situations where more flexibility and a small diameter is necessary. Polyester sutures are easy to handle and can be wrapped around or inside objects to aid in sterilization validation of a variety of situations and products. Steel Discs 8mm x 12mm x 0.45mm Steel discs are representative of materials found in an isolator, and are compatible with vapor hydrogen peroxide. We strongly recommend our polished stainless steel to eliminate crevices in the carrier which can lead to tailing. The oblong disc is inoculated with G. stearothermophilus, catalog # 3A-6100ST for use in H vapor. Discs are packaged in a Tyvek/Tyvek pouch and may be exposed in the pouch or an off-center hole in the disc allows them to be removed from their package and suspended throughout the isolator to ensure proper flow.

16 Industrial Use Biological Indicators Steel Coupons 7mm x 32.8mm x 0.45mm Steel Coupons (same size as our standard paper strip) are intended for use in dry heat ovens at depyrogenation temperatures. Inoculated with 10 6 B. atrophaeus spores, they are used to correlate spore death (sterilization) with endotoxin reduction. Mesa does not sell endotoxin or other LAL reagents at this time. Paper Discs 6mm and 9mm Paper discs have been used to validate sterilization of contact lenses in steam where placement of a strip was impossible due to its size. They are also suitable for EO, Dry Heat (up to 180 C) and radiation sterilization. Discs are also available in circular glassines. Borosilicate Discs 7mm Made from high quality glass micro-fibers, borosilicate discs are especially useful in sterilization processes where paper products are not compatible (vapor hydrogen peroxide). They are also suitable for steam, EO, Dry Heat and radiation sterilization. Steri-Chart Steri-Chart is a set of strips with 5 different populations, all made from the same spore batch for use in cycle development. Expose the five test strips to determine what level of sterility is being delivered by a particular cycle (industrial use only). Available with G. stearothermophilus (log 3, 4, 5, 6, & 7 test strips and a log 5 control) or B. atrophaeus (log 4, 5, 6, 7, & 8 test strips and a log 6 control). A control strip is included. Ten charts per bundle. Packaging Carriers can be packaged individually in glassine paper, a Tyvek pouch, or in bulk plastic bags (no primary packaging). Carriers (individually wrapped) are sold in quantities of 100. Bulk packaged items are sold in quantities of 1,000. Steel Discs are only packaged individually in Tyvek pouches. Sterilization/Carrier compatibility: Hydrogen peroxide (vapor or plasma) is not compatible with cellulosics (paper, wood pulp products), so Mesa s spore strips and blue glassine packaging cannot be used with this type of sterilization. Tyvek packaging and steel carriers are recommended. Depyrogenation temperatures (180 to 250 C) char or incinerate paper, so we recommend our steel strip carrier. This product is packaged in a Tyvek pouch so the user can handle it without contaminating the lab with spores. Mesa does not offer a foil package for our steel strips, but recommends that the user wrap the strip in foil or place it inside a glass container prior to exposure in the depyrogenation tunnel/oven. This will assist aseptic transfer to media after the exposure. Rev. 11DEC2015

17 SterilAmp II Liquid Submersible SCBI for Steam SterilAmp II is a compact, self-contained biological indicator for monitoring industrial steam sterilization of liquids in small containers. SterilAmp II precisely integrates the process lethality. 48-hour results Small, conveniently-shaped ampoule No laboratory required Dramatic color change Packaged with 10 negative controls 26mm x 6.5mm PASS FAIL SterilAmp II contains a specially formulated culture medium that turns a dramatic yellow when spores grow and provides easy visual confirmation of sterilization within 48 hours, without the need for difficult and time-consuming laboratory work. Storage Refrigerate at 2-8 C. Certification SterilAmp biological indicators are traceable to a recognized culture collection and certified for population, D-value, z-value, Fo value, and performance. Ordering Information Species Catalog # Min. Population Qty/Box G. stearothermophilus SA/4 1.0 x Tests / 10 NC G. stearothermophilus SA/5 1.0 x Tests / 10 NC G. stearothermophilus SA/6 1.0 x Tests / 10 NC Rev

18 SterilAmp II 5230 Liquid Submersible SCBI for Low Temperature Steam SterilAmp II 5230 is a compact, self-contained ampoule biological indicator for monitoring industrial low temperature ( C) steam sterilization of liquids in small containers. 26mm x 6.5mm 72-hour results Small, conveniently-shaped ampoule No laboratory required Dramatic color change Packaged with 10 Negative Controls PASS SterilAmp II 5230 contains a specially formulated culture medium that turns a dramatic yellow when spores grow, providing easy visual confirmation of sterilization within 72 hours, without the need for difficult and time-consuming laboratory work. FAIL Storage Refrigerate at 2-8 C. Certification SterilAmp II 5230 biological indicators are traceable to a recognized culture collection and certified for population, D-value, z-value, Fo value, and performance. Ordering Information Species Catalog # Min. Population Qty/Box B. subtilis 5230 SASU/6 1.0 x Tests / 10 NC MesaLabs Rev

19 DriAmp The unique DriAmp biological indicator (BI) is appropriate for either high temperature direct air exposure or submersion in oils and other non-water based solutions where traditional paper strip indicators are difficult to use. The DriAmp BI is a 1 ml snap-top glass ampoule containing silica material inoculated with 10 6 Bacillus atrophaeus (#9372) spores. All materials are compatible with extremely high temperatures such as those delivered by dry heat tunnels or ovens used for the sterilization of instruments and depyrogenation in the manufacture of aseptically filled pharmaceutical liquids. Biological Indicator for Dry Heat The Releasat culture medium is specially formulated for rapid outgrowth of B. atrophaeus, and is supplied in individual tubes for easy aseptic transfer and culturing. This medium offers the advantage of a 72-hour reduced incubation time compared to 7 days with competing products. Test results are obtained during incubation by observing the medium which changes color from red-orange to yellow if any spores have survived the process. 72-hour results Small, conveniently-shaped ampoule (49mm x 11mm) Suitable for high temperature dry heat sterilization of instrumentation and depyrogenation Dramatic color change Storage Room Temperature. Certification DriAmp biological indicators are traceable to a recognized culture collection, and certified for population, D-value, z-value, and performance. Ordering Information Species Catalog # Min. Population Sets/Box B. atrophaeus DH/ x Rev

20 Releasat Spore Strips and Culture Media Releasat is a biological indicator culturing kit containing MesaStrip paper strip biological indicators and culture tubes of specially formulated soybean casein digest culture medium containing a color indicator which turns a dramatic yellow when spores grow. Releasat culture kits are available for monitoring ethylene oxide, dry heat and chlorine dioxide sterilization processes. The color indicator provides visual results within 48 hours (ClO 2 ) or 72 hours (EO) as opposed to the standard seven days. Releasat medium is used to culture the MesaStrip in place of generic soybean casein digest medium and provides a more rapid read-out. Each lot of Releasat culture tubes are quality control tested with appropriate MesaStrips. 72 hour results (EO) 48 hour results (ClO 2 ) Dramatic color change Storage Store at room temperature. Certification MesaStrip biological indicators are traceable to a recognized culture collection and certified for population. D-value and performance using Releasat media. Each set includes Mesa- Strips and Releasat media. Ordering Information Species Use Catalog # Min. Population Sets/Box B. atrophaeus EO/Dry RG/ x B. atrophaeus ClO 2 ACD/6 & RM/ x Rev

21 Releasat ClO 2 Spore Strips and Culture Media for ClO 2 Releasat ClO 2 is a biological indicator culturing kit containing MesaStrip paper strip biological indicators and culture tubes of specially formulated soybean casein digest culture medium containing a color indicator which turns a dramatic yellow when spores grow. Releasat culture kits are available for monitoring chlorine dioxide. The color indicator provides visual results within 48 hours as opposed to the standard seven days. Releasat medium is used to culture the MesaStrip in place of generic soybean casein digest medium and provides a more rapid read-out. Each lot of Releasat culture tubes are quality control tested with appropriate MesaStrips. 48-hour results Dramatic color change Storage Store at room temperature. Certification MesaStrip biological indicators are traceable to a recognized culture collection and certified for population, D-value and performance using Releasat media. Each set includes MesaStrips and Releasat media. Ordering Information Species Catalog # Min. Population Sets/Box B. atrophaeus RCD/ x Rev

22 ProLine ProLine is a Biological Indicator system designed for use in the validation or monitoring of sterilization cycles of tubing ranging from 1/8 to 5/8 tubing ID. The ProLine PCD (Process Challenge Device) contains a filter paper disc inoculated with bacterial spores of Geobacillus stearothermophilus (for Steam) or Bacillus atrophaeus (for EO). The spore disc is packaged in a glassine envelope and is located in the center of the ProLine housing. If adequate sterilant penetration occurs, the spores on the disc will be deactivated and verify an adequate sterilization cycle. Assembly ProLine Process Challenge Device For a given length of tubing, the most difficult area to be sterilized is the mid-point of the tubing length. This is where the ProLine device must be placed. To do this, a representative piece of tubing should be cut at its mid-point. The two half lengths should now be attached to the ProLine device by slipping one end of each cut length of tubing over the tapered ends of the ProLine device. The ProLine device is now located in the most difficult area of the tubing to sterilize. Use and Placement The ProLine system with its two attached lengths of tubing should now be placed in the sterilizer along with a normal load being processed where tubing would normally be included. Post Sterilization Testing Once the sterilization cycle is completed, the ProLine and attached lengths of tubing are removed from the sterilizer chamber and transferred to an area where an aseptic transfer of the spore disc to growth media can be performed. To do this, grasp both sides of the ProLine device and break the chamber open exposing the glassine packaged spore disc. The spore disc must now be transferred aseptically to a tube of sterile Tryptic Soy Broth (TSB) and incubated for Growth/No Growth testing. The opened ProLine device halves can now be discarded as the device is a single use only product. Ordering Information Species Catalog # Min. Population Sets/Box G. stearothermophilus PL x B. atrophaeus PL x MesaLabs Rev

23 ProChem Chemical Indicators ProChem Chemical Indicators From indicator tapes and labels to Class 6 emulators, Mesa has a full line of chemical indicators for healthcare and industrial users alike. Mesa offers indicators for a variety of processes including Steam, EO, Gamma, Plasma and Dry Heat. Integrators and Emulators ProChem SSW - Steam Class 5 Moving front Integrator, no interpretation necessary. Effective across the normal sterilization range. Parallels the performance of a biological indicator. ProChem EXT - Steam Class 5 7 minutes at 135 C / 20 minutes at 121 C Laminated Color drives darker than color standard Permanent color change ProChem SSE - Steam Class 6 3 minutes at 135 C / 4 minutes at 132 C Printed color standard Laminated Lead Free Process Indicators ProChem SSI - Steam Class 4 Catalog # CI-EXT 250 Indicators / box 5 year expiry ProChem OK - Steam Sterilization Multi-Spot Indicator International Use Only Emulators, Integrators and Process Indicators Catalog # CI-SSIX 250 Indicators / bag 18 month expiry International Use Only 3 minutes at C Catalog # CI-SINT Most cost effective CI solution 250 Indicators / box 3 year expiry Drives darker than the color standard Indicator Perforated; Indicator spot / LOT# printed on both sides Pre-vacuum sterilizers operating at 121 C and 134 C Multiple spots with varied timing Single indicator suitable for multiple cycle lengths Catalog # CI-SSW 250 Indicators / box 3 year expiry Catalog # CI-OK Indicators / bag 3 year expiry ProChem Dry Heat Indicator Labels Green to dark brown / black color change Distinguishes between processed and unprocessed items Catalog # CI-DHI 1,000 indicators / roll 3 year expiry

24 ProChem Chemical Indicators ProChem Process Indicator Tapes Tapes for Steam/Chemiclave, EO and Plasma Distinguishes between processed and unprocessed items Good adhesion to woven and non-woven fabrics Gamma Indicator Labels Yellow to red color change 2 year expiry Ethylene Oxide Indicator Labels Purple to green color change 2 year expiry Bowie-Dick Type Tests Distinct, non-reversible pink to black color change Meets AAMI, EN and ISO air removal Preassembled, disposable test pack ProChem B-D Catalog # CI-BDTLF-20 Catalog # CI-BDTLF ProChem BD110* Individual Test Sheets Distinct, non-reversible blue to black color change Meets AAMI, EN and ISO air removal STEAM CI-STP-24 24mm x 55M 36 rolls / case CI-STP 18mm x 55M 48 rolls / case CI-STP-12 12mm x 55M 72 rolls / case ETHYLENE OXIDE CI-ETP 18mm x 55M 48 rolls / case Box of 20 Case of 80 Catalog # CI-R02 (METO gun label) 1,000 indicators / roll Catalog # CI-R03 (12.7mm dots) 5,000 indicators / roll Catalog # CI-E02 (METO gun label) 1,500 indicators / roll Catalog # CI-E03 (12.7mm dots) 5,000 indicators / roll ProChem B-D 121* Catalog # CI-BDTLF Catalog # CI-BDTLF-121 Catalog # CI-BD sheets / package 3 year expiry *Industrial/International Use Only Rev

25 ProChem SSW ProChem SSW Moving Front Integrator for Steam ProChem SSW Steam Sterilization Integrator is a single use Class 5 Integrating Indicator which complies with ANSI/AAMI/ISO :2005 and ANSI/AAMI ST60:1996. It integrates three essential criteria for proper steam sterilization: time, temperature, and steam. When processed along with a load it indicates, with a margin of safety, whether the proper steam sterilization criteria have been achieved at point of placement. Unprocessed Processed-Fail Processed-Accept Catalog Number: CI-SSW Qty / Box: 250 Expiry: 5 years Temperature Time in Minutes for ProChem SSW to Reach Accept Window 121 C C C 1.5 Instructions for Use 1. Place a ProChem SSW Integrator in the center of each pack or load and process according to sterilizer manufacturer s directions. 2. Adequate sterilization conditions are reached when the dark bar has completely travelled through the reject window and has entered the accept window. 3. If the dark bar does not reach the accept window, reprocessing is required. 4. Use in C gravity, flash or pre-vacuum cycles. ProChem SSW in the presence of steam will respond to time and temperature. Do not store near heat source. Rev

26 ProChem OK Multi-Spot Indicator ProChem OK - Steam Sterilization Multi-Spot Indicator Catalog # CI-OK 250 Indicators / bag 3 year expiry For International Use Only Stated Values (As determined in a steam sterilization resistometer) Spot 121 C 134 C 1 8 minutes 3.25 minutes 2 11 minutes 4.5 minutes 3 17 minutes 7 minutes 4 30 minutes 11 minutes Pre-vacuum sterilizers operating at 121 C and 134 C Multiple spots with varied timing Single indicator suitable for multiple cycle legnths 8607 Park Drive Omaha, NE USA Tel: bisales@mesalabs.com

27 Spore Suspensions Spore Suspensions Spore Suspensions are diluted aliquots from our primary spore crop (batch). They are used to directly inoculate (and therefore challenge) a material or solution with a known concentration of spores. US FDA requires medical device and pharmaceutical manufacturers to challenge their products directly with spores prior to approving them for sale. This challenge is intended to determine if the device s carrier material or pharmaceutical s properties (viscosity, salt content, etc.) has any sporicidal or preservative effect that will impact the manufacturer s ability to sterilize the product and to determine instructions on how the user can sterilize the device if reusable. Suspensions are offered in a 40% ethanol solution or 100% deionized H 2 O. Some hydrophobic materials would cause a drop (0.1ml) to bead on its surface. As this bead dries, the spores would be clumped on top of each other. For these types of materials it would be to your advantage to use the ethanol solution so the spores spread more evenly over the surface. The same is also true when inoculating into a solution, where a water inoculum may not be miscible. Spore Suspensions are available for the following species in various populations. B. atrophaeus* B. subtilis* (#6633 and des. 5230) G. stearothermophilus* (#7953, 12980, 10149) B. thuringiensis* B. pumilus* B. cereus* B. megaterium* B. coagulans* *Derived from recognized reference strains as specified within USP, ISO or EN guidelines. These products are not certified as being representative of the reference strain and they should therefore not be used where a reference culture is specified. Rev

28 Spore Suspensions Ordering Information B. atrophaeus Reference #9372 Catalog # Population (per 0.1ml) SUS-1-4 Log 4 SUS-1-5 Log 5 SUS-1-6 Log 6 SUS-1-7 Log 7 SUS-1-8 Log 8 SUS-1-9 Log 9 B. subtilis Reference #6633 Catalog # Population (per 0.1ml) SUS-1A-4 Log 4 SUS-1A-5 Log 5 SUS-1A-6 Log 6 SUS-1A-7 Log 7 SUS-1A-8 Log 8 B. subtilis Reference #35021 (des. 5230) Catalog # Population (per 0.1ml) SUS-1B-4 Log 4 SUS-1B-5 Log 5 SUS-1B-6 Log 6 SUS-1B-7 Log 7 G. stearothermophilus Reference #7953 Catalog # Population (per 0.1ml) SUS-3-4 Log 4 SUS-3-5 Log 5 SUS-3-6 Log 6 SUS-3-7 Log 7 G.stearothermophilus Reference #12980 Catalog # Population (per 0.1ml) SUS-3A-4 Log 4 SUS-3A-5 Log 5 SUS-3A-6 Log 6 SUS-3A-7 Log 7 G.stearothermophilus Reference #10149 Catalog # Population (per 0.1ml) SUS-3B-4 Log 4 SUS-3B-5 Log 5 SUS-3B-6 Log 6 SUS-3B-7 Log 7 B. thuringiensis Reference #29730 Catalog # Population (per 0.1ml) SUS-6-6 Log 6 SUS-6-7 Log 7 SUS-6-8 Log 8 SUS-6-9 Log 9 B. pumilus Reference #27142 Catalog # Population (per 0.1ml) SUS-7-4 Log 4 SUS-7-5 Log 5 SUS-7-6 Log 6 SUS-7-7 Log 7 SUS-7-8 Log 8 SUS-7-9 Log 9 B. cereus Reference #11778 Catalog # Population (per 0.1ml) SUS-8-6 Log 6 SUS-8-7 Log 7 SUS-8-8 Log 8 SUS-8-9 Log 9 B. megaterium Reference #8245 Catalog # Population (per 0.1ml) SUS-9-6 Log 6 SUS-9-7 Log 7 SUS-9-8 Log 8 SUS-9-9 Log 9 B. coagulans Reference #51232 Catalog # Population (per 0.1ml) SUS-CG-6 Log 6 Rev

29 Spore Suspensions Spore suspensions are calibrated suspensions of bacterial spores appropriate for direct inoculation of products or preparing custom biological indicators for monitoring steam, ethylene oxide, dry heat, hydrogen peroxide, radiation and other industrial sterilization processes. Each vial contains 10ml of suspension. The suspending liquid is 40% ethanol or purified water. Available in ethanol and aqueous preparations Other bacterial spores available on request Storage Aqueous: refrigerate at 2 to 8 C. 40% Ethanol: freeze at -25 to -10 C. Certification Ordering Information Spore Suspensions Spore suspensions are traceable to a recognized culture collection and certified for population, D-value and z-value (steam). B. atrophaeus Reference #9372 Catalog # Population (per 0.1ml) SSG/4 Log 4 SSG/5 Log 5 SSG/6 Log 6 SSG/7 Log 7 SSG/8 Log 8 G.stearothermophilus Reference #7953 Catalog # Population (per 0.1ml) SSS/4 Log 4 SSS/5 Log 5 SSS/6 Log 6 SSS/7 Log 7 B. pumilus Reference #27142 Catalog # Population (per 0.1ml) SSR/4 Log 4 SSR/5 Log 5 SSR/6 Log 6 SSR/7 Log 7 SSR/8 Log 8 Also available upon request: Clostridium sporogenes, B. subtilis 6633, B. smithii, B. megaterium, B. subtilis 5230, B. thuringiensis, B. licheniformis, and B. cereus. Rev

30 1410 Adjustable SCBI Incubator 1410 Adjustable Self-Contained Biological Indicator (SCBI) Incubator The Mesa 1410 incubator is designed for convenient and effective incubation of Mesa selfcontained biological indicators at 37 C (Bacillus atrophaeus ) or 57 C and 60 C (Geobacillus stearothermophilus ). The incubator features a built-in thermometer with LED display, 13 incubation cavities and an integrated activation (crushing) cavity. Convenient Simultaneous incubation of up to 13 BIs in numbered incubation cavities. Multinational 110V/220V power adapter with interchangeable blades. Incubation temperature adjustable for BIs containing B. atrophaeus (37 C) or G. stearothermophilus (57 C and 60 C). Supports 10-hour Smart-Read BIs at 60 C. User Friendly Integrated activation (crushing) cavity. Very fast warm up time (10-15 minutes depending on selected temperature). Designed for 24-hours-a-day use. Integrated thermometer with digital display. Certifications RoHS compliant, CSA C/US and CE Mark W. 6th Avenue Lakewood, CO USA Tel: bisales@mesalabs.com

31 1510 SCBI Incubator The Mesa 1510 incubator is designed for convenient and effective incubation of Mesa self-contained biological indicators at 57 C including MagnaAmp and ProSpore Ampoule 1mL liquid submersible biological indicators. Convenient Simultaneous incubation of up to 15 BIs in numbered incubation cavities. Multinational 110V/220V power adapter with interchangeable blades. Digital Temperature Display User Friendly Small footprint. Fast warm up time (30-45 minutes). Designed for 24-hour-a-day use. Reliable operation Self-Contained Biological Indicator (SCBI) Incubator Certifications RoHS compliant, CSA C/US and CE Mark Rev

32 Smart-Read EZTest Smart-Read EZTest Biological Indicator Monitoring System The Smart-Read EZTest Biological Monitoring System allows an organization to release sterile product with true biological confirmation faster and easier than ever before. This unique system uses a real biological indicator (BI) -- with no added enzyme or chemical integrator -- which is incubated, evaluated, and documented in one simple, automated operation. Relying only upon bacterial spore growth, the Smart-Read system can detect sterilization failure in as few as three to five hours, and negative results can be confirmed with ten hours of incubation. Ordering Information Smart-Read EZTest SCBI Fast biological results True biological system Easy one-step evaluation Automatic documentation Sterilization failure alarm 100% verifiable results Species Catalog # Min. Population Qty/Box G. stearothermophilus SEZS/5 1.0 x G. stearothermophilus SEZS/6 1.0 x Smart-Read EZTest Biological Indicator Test Pack (PCD) Species Catalog # Min. Population Qty/Box G. stearothermophilus SRSP/ x Tests / 5 Controls G. stearothermophilus SRSP/ x Tests / 25 Controls Smart-Well Incubator Cord Incubation Cells Temperature Catalog Number United States control 60 C SWI European control 60 C SWI Australian control 60 C SWI United Kingdom control 60 C SWI Rev