CATALOG BIOLOGICAL AND CHEMICAL INDICATORS

Transcription

1 CATALOG BIOLOGICAL AND CHEMICAL INDICATORS

2 Biological Indicators Mesa Labs - for sterilization process control - A biological indicator is broadly defined as a characterized preparation of a specific microorganism that provides a defined and stable resistance to a specific sterilization process. Microorganisms widely recognized as suitable for biological indicators are spore-forming bacteria, because, with the exception of ionizing radiation processes, these microorganisms are significantly more resistant than normal microflora. A biological indicator can be used to assist in the performance qualification of the sterilization and in the development and establishement of a validated sterilization process for a particular article. Biological indicators are used in processes that render a product sterile in its package or container, as well as for the sterilization of equipment, materials, and packaging components used in aseptic processing. Biological indicators may also be used to monitor established sterilization cycles and in periodic revalidation of sterilization processes. Biological indicators may also be used to evaluate the capability of processes used to decontaminate isolators or aseptic clean-room environments. Certification MesaLabs, Inc is specializated in high quality biological indicator production. Mesa Labs is a grupation that includes former specialized biological indicators manufacturers SGM Biotech and Raven. Quality of biological indicators is controled in accordance with high standards of Mesa Labsa, ISO, GMP, USP, AAMI/ANSI norms and with european EP standards. All Mesa Labs biological indicators are accompanied with suitable certificate of analysis that provides caracteristics and quality. - Certificate of Analysis - Name and ATCC number of bacterial species Spore population D-value Survival/Kill time Z-value (for steam) Fo-value (for SterilAmp II and MagnaAmp) Type of sterilization Series number Manufacturing date Expiration date Instruction for use Regulatory references 2

3 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 an additional five hours of incubation (10 hours total). The Smart-Read system includes the Smart-Read EZTest self-contained biological indicator which is specially designed for rapid evaluation in our advanced Smart-Well incubator. Based on familiar, proven technology, the Smart-Read system can be implemented by any organization with minimal training and validation. Fast biological results True biological system Easy one-step evaluation Automatic documentation Alarm on sterilization failure 100% verifiable results Smart Well and accessories SW Smart -Well inkubator, European Power, Includes Unit, Printer Manual and Power Pack IDT2 Smart- Well Thermometer - Digital Keychain Thermometer P EURO - Power pack for Printer 9503 Printer Ribbon/Paper Kit 1 ink/2 Rolls PTRIPPR Printer Papaer Roll PTR/INK Printer Ink 3

4 Spore Strip strips inoculated with bacterial spores Spore strips are packaged in a peel open glassine paper pouch. Glassine paper is permeable to sterilant but resistant to moisture and air at ambient temperature/ pressure. This allows the user to transport the strip within the glassine from the sterilizer to a laminar flow hood, where it can be transferred into recovery medium. D-values are within suggested ranges mentioned in USP and suitable for hospital use. We also provide spore strips that comply with EN/ISO and other international requirements. We follow USP in recommending Tryptic Soy Broth (SCDB) as a recovery medium. Use of any other medium may adversely affect results SGMS/3 SGMS/5 SGMS/6 PM/100 STEAM STERILIZATION HOSPITAL PACKS 25 Envelopes (Tests) Each test consists of three spore strips available with G. stearothermophilus, B. atrophaeus, or Combined species strips. STEAM STERILIZATION Spore strips with Geobacillus stearothermophilus 10x3 ATCC 7953, Pack/100pcs Spore strips with Geobacillus stearothermophilus 10x5 ATCC 7953, Pack/100pcs Spore strips with Geobacillus stearothermophilus 10x 6 ATCC 7953, Pack/100pcs TSB culturing media with purple ph indicator, pcs 3,6+/-0,2 ml in tubes 16x100 mm, Pack/ of 100 tubes Spore strips with Geobacillus stearothermophiluslog 5 ATCC 7953, Pack/1000pcs Spore strips with Geobacillus stearothermophiluslog 5 ATCC 7953, Pack/100pcs Spore strips with Geobacillus stearothermophilus Log 6 ATCC 7953, Pack/100pcs SGMG/6 SGMG/7 RM/100 STERILIZATION EO AND DRY HEAT Spore strips with Bacillus atrophaeus 10x6 ATCC 9372, Pack/100pcs Spore strips with Bacillus atrophaeus 10x7 ATCC 9372, Pack/100pcs TSB culturing media with purple ph indicator, pcs 3,6+/-0,2 ml in tubes 16x100 mm, Pack of 100 tubes Spore strips with Bacillus atrophaeus1log6, Pack/1000pcs Spore strips with Bacillus atrophaeus 1Log6, Pack/100pcs Spore strips with Bacillus atrophaeus 1Log6, Pack/50pcs STEAM STERILIZATION, EO OR DRY HEAT - DUOSPORE Spore strips with G. stearothermophilus 10x5 ATCC 7953 and B. atrophaeus 10x6 ATCC 9372, Pack/1000pcs Spore strips with G. stearothermophilus 10x5 ATCC 7953 and B. atrophaeus 10x6 ATCC 9372, Pack/100pcs SGMR/6 SGMSU/6 ACD/6 RADIATION STERILIZATION Spore strips Bacillus pumilus 10x6 ATCC 27142, Pack/100pcs STEAM STERILIZATION AT LOW TEMPERATURES Spore strips with B.subtilis x6 ATCC 5230, Pack/100pcs CLO2 STERILIZATION Sterilization strips chlorine dioxide with spores B.atrophaeus 10x6 ATCC Pack/100pcs 4

5 EZTest EZTest is a self-contained biological indicator for monitoring steam / flash 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. Incubation time: 24 h for EZS/6 i EZP/5 and 48 h for EZF and EZG. Change of colour: EZS,EZP i EZH from purple to yelow, EZG from red to yellow. EZS/5 EZS/525 STEAM STERILIZATION Incubation: 24 h, C EZTest Steam with spores G stearothermophilus 10x5 ATCC 7953, Pack/100 pcs. EZTest Steam with spores G stearothermophilus10x5 ATCC 7953, Pack/25 pcs EZS/6 EZTest Steam with spores G stearothermophilus 10x6 ATCC 7953, Pack/100 pcs. EZS/625 EZTest Steam with spores G stearothermophilus 10x6 ATCC 7953, Pack/25 pcs. SEZS/5 EZTest Steam with spores G stearothermophilus 10x5 ATCC 7953 With dubble activator for fast reading. Pack/100 pcs. SEZS/525 EZTest Steam with spores G stearothermophilus 10x5 ATCC 7953 With dubble activator for fast reading. Pack/25 pcs. SEZS/6 EZTest Steam with spores G stearothermophilus 10x6 ATCC 7953 With dubble activator for fast reading. Pack/100 pcs. SEZS/625 EZTest Steam with spores G stearothermophilus 10x6 ATCC 7953 With dubble activator for fast reading. Pack/25 pcs. SRSP/25 SRSP6/25 EZG/6 EZG/625 EZH/5 EZH/6 CRUSHER / SGMWNL EXPO/6 Smart-Read EZTest steam test pack G stearothermophilus 10x5 ATCC 7953, Pack/25pcs + 25nc Smart-Read EZTest steam test pack G stearothermophilus10x6 ATCC 7953, Pack/25pcs + 25nc EO STERILIZATION Incubation: 48 h, C EZTest Gas with spores Bacillus atrophaeus 10x6 ATCC 9372, Pack/100 pcs. EZTest Gas with spores Bacillus atrophaeus 10x6 ATCC 9372, Pack/25 pcs. H2O2 STERILIZATION Incubation: 24 h, C, spores inoculated on the steel disc EZTest H2O2 with spores G stearothermophilus 10x5 ATCC 7953 inoculated on the steel disc, Pack/100 pcs EZTest H2O2 with spores G stearothermophilus 10x6 ATCC 7953 inoculated on the steel disc, Pack/100 pcs. EZTest chrusher EXSPOSURE STERRAD Incubation: 24 h, C Used as a standard method for frequent monitoring of the following STERRAD Sterilizer Systems used in Healthcare facilities., Pak/30 pcs. Approved Cycles: STERRAD 50, STERRAD 100S (Short & Long), STERRAD 200 (Short & Long) STERRAD NX (Advanced & Standard), STERRAD 100NX (STANDARD, FLEX, DUO, and EXPRESS) Placment: 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 5

6 Releasat Rapid-Readout Color Change Culturing Kit 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 industrial steam, chlorine dioxide, or ethylene oxide and dry heat sterilization processes. PM/100 RG-100 STEAM STERILIZATION TSB media with purple ph indicator, qt 3,6+/-0,2 ml in tubes 16x100 mm, Pack of 100 tubes DRY HEAT STERILIZATION /EO STERILIZATION Kit is made of :100 Spore strips Bacillus atrophaeus 10x6 ATCC 9372, 100 tubes with special media RM/100 TSB culture media with red ph indicator, quantity 3,6+/-0,2 ml in tubes 16x100 mm, Pack of 100 tubes C P-PA TSB culture media with pourple ph indicator and G stearothermophilus quantity 6,5ml in tubes 16x100 mm 10x6 ATCC 7953, Pack of 25 tubes and 25 strips TSB-BP16 TSB culture media with pourple ph indicator 6,5ml in tubes 16x100 mm, Pack of 100 DriAmp The unique DriAmp biological indicator 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 106 Bacillus atrophaeus (#9372) spores. 72 hours results Small, conveniently-shaped ampoule ( 49mm x 11mm ) Suitable for high temperature dry heat sterilization of instrumentation and depyrogenation DH/50 DRY HEAT STERILIZATION Kit is made of: 50 ampoule with spores Bacillus atrophaeus 10x6 ATCC tubes containing 4,0 ml cultural media 6

7 MagnaAmp self-contained biological indicator MagnaAmp is a self-contained ampoule biological indicator ampoule for monitoring steam sterilization of liquids in ampoules, large 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 hours results STEAM STERILIZATION Incubation : 48 h, C MA/4 MagnaAmp with spores Geobacillus stearothermophilus 10x5 ATCC 7953 Pack of 50 indicators and 10 negative control. MA/5 MagnaAmp with spores Geobacillus stearothermophilus 10x5 ATCC 7953 Pack of 50 indicators and 10 negative control. MA/6 MA/6 MagnaAmp with spores Geobacillus stearothermophilus10x6 ATCC 7953 Pack of 50 indicators and 10 negative control. MANC MagnaAmp 10 negative control : PS-4-10 PS-4-50 PS-5-10 PS-5-50 PS-6-50 ProSpore ampule Geobacillus stearothermophilus 14.75mm x 52mm 10x4 ATCC 7953 Pak: 10/box ProSpore ampule Geobacillus stearothermophilus 14.75mm x 52mm 10x4 ATCC 7953 Pak: 50/box ProSpore ampule Geobacillus stearothermophilus 14.75mm x 52mm 10x5 ATCC 7953 Pak: 10/box ProSpore ampule Geobacillus stearothermophilus 14.75mm x 52mm 10x5 ATCC 7953 Pak: 50/box ProSpore ampule Geobacillus stearothermophilus 14.75mm x 52mm 10x6 ATCC 7953 Pak: 50/box 7

8 SterilAmp II self-contained biological indicator SterilAmp II is a compact, self-contained biological indicator for monitoring industrial steam (121 C) sterilization of liquids in small containers. SterilAmp II precisely integrates the process lethality. SterilAmp II contains a specially formulated culture medium that turns a dramatic yellow when spores grow. The SterilAmp II provides easy visual confirmation of sterilization within 48 hours, without the need for difficult and time-consuming laboratory work. 48 hour results Small, conveniently-shaped ampoule ( 26mm x 6.5mm, 18mm size also available), Negative controls are included with each box of product. STEAM STERILIZATION Incubation: 48 h, C SA/4 SterilAmp with spores Geobacillus stearothermophilus 10x4 ATCC 7953 Pack of 100 indicators and 10 negative control. SA/5 SterilAmp with spores Geobacillus stearothermophilus 10x5 ATCC 7953 Pack of 100 indicators and 10 negative control. SA/6 SterilAmp with spores Geobacillus stearothermophilus 10x6 ATCC 7953 Pack of 100 indicators and 10 negative control. SANC SA/6 10 negative control. STERIL AMP II 6,75MM X 17MM SA18/6 SterilAmp with spores Geobacillus stearothermophilus 10x6 ATCC 7953 Pack of 100 indicators and 10 negative control. SA18/NC50 SterilAmp with spores Geobacillus stearothermophilus10x5 ATCC 7953 Pack of 100 indicators and 10 negative control. SANC18 SA18/NC50 SA/6 10 negative control. SterilAmp II "5230" STEAM STERILIZATION AT LOW TEMPERATURES, C Incubation: 72 h, 37 C SASU SterilAmp with spores Bacillus subtilis x6 ATCC Pack of 100 indicators and 10 negative control. SASUNC SASU SA/6 10 negative control.. 8

9 Spore Suspension Suspensions offered in a 40% ethanol solution or 100% deionized H2O. 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. SSSE/3 SSSE/4 SSSE/5 SSSE/6 SSSE/7 SSSA/7 SSGE/4 SSGE/5 SSGE/6 SSGE/7 SSGE/8 SSRE/4 SSRE/5 SSRE/6 SSRE/7 SSRE/8 GEOBACILLUS STEAROTHERMOPHILUS Spore suspension Geobacillus stearothermophilus 10x3 ATCC 7953 /0.1 ml / Pack-vial 10 ml / 40% Ethanol Spore suspension Geobacillus stearothermophilus 10x4 ATCC 7953 /0.1 ml / Pack-vial 10 ml / 40% Ethanol Spore suspension Geobacillus stearothermophilus 10x5 ATCC 7953 /0.1 ml / Pack-vial 10 ml / 40% Ethanol Spore suspension Geobacillus stearothermophilus 10x6 ATCC 7953 /0.1 ml / Pack-vial 10 ml / 40% Ethanol Spore suspension Geobacillus stearothermophilus 10x7 ATCC 7953 /0.1 ml / Pack-vial 10 ml / 40% Ethanol Spore suspension Geobacillus stearothermophilus10x7 ATCC 7953 /0.1 ml / Pack-vial 10 ml/ Aqueous BACILLUS ATROPHAEUS Spore suspension Bacillus atrophaeus 10x4 ATCC 9372 /0.1 ml / Pack-vial 10 ml / 40% Ethanol Spore suspension Bacillus atrophaeus 10x5 ATCC 9372 /0.1 ml / Pack-vial 10 ml / 40% Ethanol Spore suspension Bacillus atrophaeus 10x6 ATCC 9372 /0.1 ml / Pack-vial 10 ml / 40% Ethanol Spore suspension Bacillus atrophaeus 10x7 ATCC 9372 /0.1 ml /Pack-vial 10 ml / 40% Ethanol Spore suspension Bacillus atrophaeus 10x8 ATCC 9372 /0.1 ml / Pack-vial 10 ml / 40% Ethanol BACILLUS PUMILUS Spore suspension Bacillus pumilus 10x4 ATCC /0.1 ml / Pack-vial 10 ml / 40% Ethanol Spore suspension Bacillus pumilus 10x5 ATCC /0.1 ml / Pack-vial 10 ml / 40% Ethanol Spore suspension Bacillus pumilus10x6 ATCC /0.1 ml / Pack-vial 10 ml / 40% Ethanol Spore suspension Bacillus pumilus 10x7 ATCC /0.1 ml / Pack-vial 10 ml/ 40% Ethanol Spore suspension Bacillus pumilus 10x8 ATCC /0.1 ml / Pack-vial 10 ml/ 40% Ethanol SS6633E/4 SS6633E/5 SS6633E/6 SS6633E/7 SS6633E/8 SS6633A/7 BACILLUS SUBTILIS 6633 Spore suspension Bacillus subtilis x4 ATCC 6633 /0.1 ml / Pack-vial 10 ml / 40% Ethanol Spore suspension Bacillus subtilis x5 ATCC 6633 /0.1 ml / Pack-vial 10 ml / 40% Ethanol Spore suspension Bacillus subtilis x6 ATCC 6633 /0.1 ml / Pack-vial 10 ml / 40% Ethanol Spore suspension Bacillus subtilis x7 ATCC 6633 /0.1 ml / Pack-vial 10 ml / 40% Ethanol Spore suspension Bacillus subtilis x8 ATCC 6633 /0.1 ml / Pack-vial 10 ml / 40% Ethanol Spore suspension Bacillus subtilis x7 ATCC 6633 /0.1 ml / Pack-vial 10 ml / Aqueous SS5230E/4 SS5230E/5 SS5230E/6 SS5230E/7 SS5230E/8 SS5230A/7 BACILLUS SUBTILIS 5230 Spore suspension Bacillus subtilis x4 ATCC /0.1 ml / Pack-vial 10 m / 40% Ethanol Spore suspension Bacillus subtilis x5 ATCC /0.1 ml / Pack-vial 10 m / 40% Ethanol Spore suspension Bacillus subtilis x6 ATCC /0.1 ml / Pack-vial 10 m / 40% Ethanol Spore suspension Bacillus subtilis x7 ATCC /0.1 ml / Pack-vial 10 m / 40% Ethanol Spore suspension Bacillus subtilis x8 ATCC /0.1 ml / Pack-vial 10 m / 40% Ethanol Spore suspension Bacillus subtilis x7 ATCC /0.1 ml / Pack-vial 10 m/aqueous 9

10 Micro Strip (Custom strip) inoculated with bacterial spores Strip - Paper spore strips are available in different sizes and can be used in any sterilization method compatible with paper products. Micro Strips are available in bulk (1,000 units) or packaged in glassine envelopes (100 units). Incubation: 7 days S1X25/6 STEAM STERILIZATION Strip 1 x 25 mm with spores G. stearothermophilus 10x6 ATCC 7953 Pack/ 100 strips/bulk S1X25/6G Strip 1 x 25 mm with spores G. stearothermophilus 10x6 ATCC 7953 In Glassine / 100 strips pack S2x10/6 Strip 2 x 10 mm with spores G. stearothermophilus 10x6 ATCC 7953,Pack/ 100 strips/bulk S2x10/6G Strip 2 x 10 mm with spores G. stearothermophilus10x6 ATCC 7953 In Glassine / 100 strips pack SU1x25/6 Strip 1 x 25 mm with spores B. Subtilis x6 ATCC 35021, Pack/ 100 strips/bulk EO STERILIZATION / DRY HEAT A1x25/6 Strip 1 x 25 mm with spores Bacillus atrophaeus 10x6 ATCC 9372 Pack/ 100 strips/bulk A1x25/6G Strip 1 x 25 mm with spores Bacillus atrophaeus 10x6 ATCC 9372 In Glassine / 100 strips pack A2x10/6 Strip 2 x 10 mm with spores Bacillus atrophaeus 10x6 ATCC 9372 Pack/ 100 strips/bulk A2x10/6G Strip 2 x 10 mm with spores Bacillus atrophaeus 10x6 ATCC 9372 In Glassine / 100 strips pack 10

11 Steel discs Steel discs (8mm x 12mm x 0.45mm) 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. Discs are packaged in a Tyvek/Tyvek pouch and may be exposed in the pouch or an off- HMV-091E3 GEOBACILLUS STEAROTHERMOPHILUS, STEAM AND H 2 O 2 Steel discs with spores G.stearothermophilus 10x3 ATCC 12980, Pack/100 pcs HMV-091 Steel discs with spores G.stearothermophilus 10x6 ATCC 12980, Tyvek/Tyvek Pak/100 pcs KCD-404 SBC-327 Discs with spores G.stearothermophilus 10x4 ATCC 12980, Tyvek/Tyvek Pack/100 pcs Steel discs with spores G.stearothermophilus 10x6 ATCC 12980, Pack/ 100 pcs LOG-456 Indicator Tri-scale with spores G.stearothermophilus 10x4, 10x5 i10x6 ATCC 12980, Tyvek/Tyvek Pack/50 pcs GRS-090E3 GRS-090 NAS-152E3 NAS-152 BMWK-750 Steel discs with spores B. atropheus 10x3 ATCC 9372, Tyvek/Tyvek Pack/100 pcs Steel discs with spores B. atropheus 10x6 ATCC 9372, Tyvek/Tyvek Pack/100 pcs Steel discs with spores G.stearothermophilus 10x3 ATCC 7953, Tyvek/Tyvek Pack/100 pcs Steel discs with spores G.stearothermophilus 10x6 ATCC 7953, Tyvek/Tyvek Pack/100 pcs Steril Tyvek Transfer Pocket with SBC-327, Pack/ 100 pcs. LAU-196 Spore suspenzion for gaseous hydrogen peroxide G.stearothermophilus 10X7/0.1ml ATCC 12980, Pack 10 ml vial LPT-606 Spore suspenzion for gaseous hydrogen peroxide G.stearothermophilus 10X7/0.1ml ATCC 7953, Pack 10 ml vial PM/ TT YT YT TSB media for HMV-091, KCD-404 i LOG-456 MICRO STRIPS Cotton Thread 19mmx1.5mm, Bacillus atrophaeus, 10x6 ATCC 9372,Tyvek/Tyvek Pack/100 pcs/bulk Polyester Suture 5 cm x0.15dia Bacillus atrophaeus, 10x6 ATCC 9372, Tyvek/Tyvek Pack/100 pcs/bulk Cotton Thread 5 cm x0.15dia G.stearothermophilus, 10x6 ATCC 9372, Tyvek/Tyvek Pack/100 pcs/bulk Paper Discs 6mm, Bacillus atrophaeus, 10x6 ATCC 9372, Pack/1000 pcs/bulk DS6R/ PB PB TSB-BP16 Paper Discs 6mm, G.stearothermophilus, 10x6 ATCC 7953,Pack/100 pcs/bulk Paper Discs 9mm, Bacillus atrophaeus, 10x6 ATCC 9372, Pack/1000 pcs/bulk Paper Discs 9mm, G.stearothermophilus, 10x6 ATCC 7953, Pack/1000 pcs/bulk Paper Discs 6mm, G.stearothermophilus, 10x6 ATCC 7953, Pack/100 pcs/bulk PL PROLINE PCD PCD, G.stearothermophilus, 10x6 ATCC 7953, Pack/15 11

12 Incubators for EZTest and MagnaAmp biological indicators Model 1410 Features: Thirteen (13) individually numbered incubation cavities. Integrated thermometer for easy temperature reference. Activation cavity for activating (crushing) crushable selfcontained biological indicators. Three temperature settings: 37 C for EO Gas, 57 C for steam, and 60 C for Smart-Read EZTest 10 hour biological indicators for steam. Fast warm up time INKUBATORI I 1410 Incubator with 13 holes for EZTest with digital termometer I 1480 Incubator 1480 with 14 holes for ProSpore I 1510 Incubator 1510 with 15 holes for MagnaAmp IDT2 Digital termometer P Power Termometer, Termometer, Termometer, 1510 PAK- Population Assay Kit Our Population Assay Kit contains all the materials required to perform accurate population assays of Mesa Labs BMF s biological indicator products. The kit includes:. PAK Kit : 4 x (19,50 x 145 mm) sterile flat-bottom tubes 4 x 6 mm glass beads 12 x (16 x 125 mm) sterile dilution blank tubes 8 x 1ml pipettes 8 x 2ml pipettes 2 x 5ml pipettes PAK-M 1 x 240 ml media POPULATION ASSAY KIT 12

13 SERVICES BI Contract Testing Services Mesa Labs offers Steam and EO D-value or Survival/Kill testing in state-of-the-art BIER Vessels. D-value procedures used follow USP/ISO and can be obtained via Spearman Karber (fraction negative) method, Survivor Curve (direct enumeration) or with Stumbo-Murphy-Cochran. Mesa Labs can inoculate and perform D-value analysis on small items (e.g. coupons or stoppers) or we can verify a competitor s claim for D-value, z- value, and population. Isolate identification services available for most aerobic samples. A summary of Mesa s testing services are listed below: Commercial Biological Indicators (BIs) Certificate of Analysis Verification BI Culturing Population Determination Identification/Purity Testing D-value Testing (Steam, EO, Dry Heat, H2O2 z-value Testing Survival Kill Verification Custom BI Development Ampoule Filling for Self-Contained BIs BI Development for Novel Sterilization Process Inoculation of Client Provided Substrate Population and Resistance Characterization Pharmaceutical Solutions (D-value, Z-value, and Bioburden Testing) Stopper/Septa (D-value/Z-value Testing) Custom Inoculation for Sterilization Cycle Validation Studies Steam Autoclave Testing 13

14 CHEMICAL INDICATORS

15 CHEMICAL INDICATORS SteriTec Products Inc. with the vision of advancing the sterilization field with innovative and highly effective sterility assurance products. The company specializes in thermographic ink technology and has invented whole product categories such as disposable Bowie-Dicks and Biological test packs. The latest innovation is a monitor to measure the efficiency of washers. SteriTec s Purple-to-Green ink technology has improved the sterilization process. This proprietary ink helps users detect problems in the sterilization process before catastrophic failures occur. Our mission is to advance sterilization technology through innovative products and excellence in quality!. Patient care starts with the proper and efficient cleaning and sterilization of the instruments used in any patient s medical or dental procedure. Visual confirmation of cleanliness is not enough; you must have a monitor that closely mimics the removal of blood and proteins. I. Wash release Wash release Experts believe that the cleaning of instrumenrts is even more important than the sterilization process because unless the instrument is clean it can t be sterilized. When choosing a wash monitor, you want a monitor that looks for problems in your process. II. Machine Release SteriTec is the expert in Bowie-Dick tests. Its founders developed the first disposable Bowie- Dick test pack and created the smallest and least expensive Bowie-Dick test, Green Card.. III.Load release The Heli-Check Process Challenge Device (PCD) is reusable device with disposable chemical indicator strip. The indicator will change from pink to black when exposed to proper steam sterilization conditions and can be used as a permanent record. By removing the back releaser liner and sticking the indicator to a sterilization record. IV. Pack release It is important to monitor the pacs within a load. It is the only way to ensure proper sterilization conditions have reached the instruments in the pack. SteriTec offers sterilant specific inks which have an advantage over simple heat sensitive inks

16 BOWIE-DICK PRODUCTS BOWIE-DICK GREEN CARD BD 117 Pack/ 120 cards 3,5 min / 134 C ISO Class 2, EN ISO A Bowie-Dick Test Card designed for daily monitoring of pre-vacuum steam sterilizers operating at 132 C for 3.5 minutes. The Green Card s advanced technology provides more information than Bowie-Dick Test Packs. In addition to detecting air leaks, inadequate steam penetration and vacuum pump failures, it will detect wet steam, superheated steam and non-condensable gases. Purple to green ink technology, ANSI/AAMI/ISO Unexposed Pass Fail Medium Fault Pass Water spray Fail Large Fault Pass 16

17 BOWIE-DICK PRODUCTS BOWIE-DICK TEST SHEET BD 110 3,5 min / 134 C Pakiranje: 100 sheets/pacl Class 2, EN , ISO Color change: from blue to black BOWIE-DICK- TEST PACK CI-BDTLF-20 3,5 min / 134 C Pakiranje: 120 test pack/ box Class 2 Color change: from blue to black BOWIE-DICK GREEN CARD T BD 120 3,5 min / 134 C Pack: 15 pcs/pack Class 2, EN867-5 Color change: from purple to green 17

18 STEAM STERILIZATION CHEMICAL INDICATORS CI 108/ Steam Charts 121 & 134 Class 5 laminated integrator designed for use in pre-vacuum steam sterilizers operating at 121 C for 8 minutes, 11 minutes, 17 minutes and 30 minutes. Also for use at 134 C for 3.25 minutes, 4.5 minutes, 7 minutes and 11 minutes. There are four different timing indicators on each strip. Purple to green ink technology. Pack: 250pcs Class 5 (EN 867-1, ISO , AAMI ST60). Unexposed Pass Excessive Fail 18

19 STEAM STERILIZATION CHEMICAL INDICATORS CT3310MM 19X55 CT3310MM 25X55 Steam Autoclave Tape Color change: from white to brown/black Dimensions: 25 mm x 55m (CT3310MM 25X55) Dimensions 19 mm x 55 m (CT3310MM 19X55)) Class 1, ISO ISO CROSS-CHECKS L CI 111 9,5 min / 121 C 3,5 min / 132 C 3 min / 134 C Pack: 250pcs Class 4, EN ISO Color change: from yellow to brown/black CROSS-CHECKS CI min / 121 C 2,5 min / 134 C Pack: 250pcs Color change: from yellow to brown/black Class

20 STEAM STERILIZATION CROSS-CHECKS LS CI min / 121 C 5 min / 134 C Pack: 250 pcs Class 4 Purple to green ink technology. CROSS-CHECKS S CI 134 2,5 min / 134 C Pack: 250 pcs Class 4 Color change: from blue to black STERI-VAPEUR 18 CI MIN 4 min / 134 C Class 4 18 MIN 19 min / 134 C Class 6 Unexposed INTEGRAPH CI min / 121 C 3,5 min / 134 C Pack: 250 pcs Class 5 Color change: from purple to green Pass extended cycle First field Process indicator Middle field Integrator Short field Extended cycle EXTENDED CYCLE 20

21 STEAM STERILIZATION EMU-GRAPH A (Adhesive) CI min/121 C 4 min/134 C Class 6 Pack: 250pcs EMU-GRAPH A (Adhesive) CI min /121 C 5,3 min / 134 C Class 6 Pack: 250pcs EMU-GRAPH A (Adhesive) CI ,5 min /121 C 7 min/134 C Class 6 Pack: 250pcs EMU-GRAPH 5 CI min /121 C 6,5 min/134 C Class 6, Pack: 250pcs EMU-GRAPH 7 CI ,5 min/121 C 7 min/134 C Class 6, Pack: 250pcs EMU-GRAPH CI 144/INT 4 min/134 C Class 6, Pack: 250pcs EMU-GRAPH 9 CI min/121 C 9 min/134 C Class 6, Pack: 250pcs 21

22 DRC HEAT STERILIZATION CHEMICAL INDICATORS INDICATOR DRY HEAT STERILIZATION CI (+/-2) min. /160 C Pack: 1000 labels Class 4 DRY HEAT INDIKATOR CI (+/-2) min. /160 C Pack: 250pcs Class 4 CHEMICAL INDICATORS FOR ETHYLENE OXIDE GAS STERILIZATION CI 124 EO Tape 19 mm x 55 m Color change: from brown to green 600mg/l EO, 40-60% RH, 54.5 C- 45min +/- 5 min. CROSS-CHECK EO CI F, 45-60%., 600mg/L Pack: 250pcs Class 4 Color change: from yellow to brown CROSS-CHECKS P H 2 O 2 CI 115 Pack: 250pcs Class 1 Color change: from blue to pink 22

23 FORMALDEHYDE STERILIZATIONS CROSS-CHECKS F C118 Pack: 250pcs Class 4 EN ISO Color change: from red to green HOLLOW LOAD PROCESS CHALLENGE DEVICES HELIPAC HOLLOW LOAD TEST LT 102/121 First rectangle 5 min/121 C Second rectangle 15 min/ 121 C LT 102/134 First rectangle 1,7 min/134 C Second rectangle 5 min/134 C LT 102/18 First rectangle 5 min/134 C Second rectangle 18 min/ 34 C Class 2 HELI-CHECK HOLLOW LOAD PCD LT104 Pack: 250pcs + 1 pcd 3,5 min / 134 C 5,3 min / 134 C 7 min / 134 C 18 min / 134 C 23

24 WASHING MONITORS INDICATORS FOR WASH PHASE IN WASHER-DISINFECTORS HOSPITAL WASHER DISINFECTOR CONTROL WASH-CHECKS WC101 WASH-CHECKS H WC105 Pack: 100pcs ULTRASONIC CLEANER WASH-CHECKS ULTRASONIC WC 108 WASH-CHECKS UH WC Pack: 100pcs 24

25 WASH CHECKS PRO WC112 RETORT-CHECKS RC101 A food processing indicator Color change: from purple to green Pack: 250pcs RETORT CHECKS Retort Checks-B /121,1 C 6 min Retort Checks-C /121,1 C 15 min Retort Checks-D /121,1 C 25 min Retort Checks-E /121,1 C 35 min Retort Checks-F /121,1 C 45 min Retort Checks-G /121,1 C 60 min Retort Checks-H /121,1 C 95 min 25

26 Put za Forticu 12/c, Opatija Hrvatska Tel: +385/(0) Fax: +385/(0) EXLUSIVE DISTRIBUTER DISTRIBUTER Steritec Products Inc.