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CATALOG BIOLOGICAL AND CHEMICAL INDICATORS www.sopex.hr 2018

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Page 1: CATALOG - Sopexsopex.hr/wp-content/uploads/2018/07/BICI_ENG_2018.pdf · • 100% verifiable results 3 SW1710-3 Smart -Well inkubator, European Power, Includes Unit, Printer Manual

CATALOGBIOLOGICAL AND CHEMICAL INDICATORS

www.sopex.hr 2018

Page 2: CATALOG - Sopexsopex.hr/wp-content/uploads/2018/07/BICI_ENG_2018.pdf · • 100% verifiable results 3 SW1710-3 Smart -Well inkubator, European Power, Includes Unit, Printer Manual

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.

CertificationMesaLabs, 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 • Type of sterilization

• Spore population • Series number

• D-value • Manufacturing date

• Survival/Kill time • Expiration date

• Z-value (for steam) • Instruction for use

• Fo-value (for SterilAmp II and MagnaAmp) • Regulatory references

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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

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SW1710-3 Smart -Well inkubator, European Power, Includes Unit, Printer Manual and Power Pack

IDT2 Smart- Well Thermometer - Digital Keychain Thermometer

P4-1000 EURO - Power pack for Printer

9503 Printer Ribbon/Paper Kit 1 ink/2 Rolls

PTRIPPR Printer Papaer Roll

PTR/INK Printer Ink

Smart Well and accessories

www.sopex.hr

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Spore Strip ™ strips inoculated with bacterial sporesSpore 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.

STEAM STERILIZATION – HOSPITAL PACKS

5-5025

25 Envelopes (Tests) – Each test consists of three spore strips available with G. stearothermophilus, B. atrophaeus,or Combined species strips.

STEAM STERILIZATIONSGMS/3 Spore strips with Geobacillus stearothermophilus 10x3 ATCC 7953, Pack/100pcs

SGMS/5 Spore strips with Geobacillus stearothermophilus 10x5 ATCC 7953, Pack/100pcs

SGMS/6 Spore strips with Geobacillus stearothermophilus 10x 6 ATCC 7953, Pack/100pcs

PM/100 TSB culturing media with purple pH indicator, pcs 3,6+/-0,2 ml in tubes 16x100 mm, Pack/ of 100 tubes

3-1000 Spore strips with Geobacillus stearothermophilusLog 5 ATCC 7953, Pack/1000pcs

3-5100 Spore strips with Geobacillus stearothermophilusLog 5 ATCC 7953, Pack/100pcs

3-6100 Spore strips with Geobacillus stearothermophilus Log 6 ATCC 7953, Pack/100pcs

STERILIZATION EO AND DRY HEATSGMG/6 Spore strips with Bacillus atrophaeus 10x6 ATCC 9372, Pack/100pcs

SGMG/7 Spore strips with Bacillus atrophaeus 10x7 ATCC 9372, Pack/100pcs

RM/100 TSB culturing media with purple pH indicator, pcs 3,6+/-0,2 ml in tubes 16x100 mm, Pack of 100 tubes

1-1000 Spore strips with Bacillus atrophaeus1Log6, Pack/1000pcs

1-6100 Spore strips with Bacillus atrophaeus 1Log6, Pack/100pcs

1-6500 Spore strips with Bacillus atrophaeus 1Log6, Pack/50pcs

STEAM STERILIZATION, EO OR DRY HEAT - DUOSPORE5-1000 Spore strips with G. stearothermophilus 10x5 ATCC 7953 and B. atrophaeus 10x6 ATCC 9372 , Pack/1000pcs

5-5100 Spore strips with G. stearothermophilus 10x5 ATCC 7953 and B. atrophaeus 10x6 ATCC 9372 , Pack/100pcs

RADIATION STERILIZATIONSGMR/6 Spore strips Bacillus pumilus 10x6 ATCC 27142, Pack/100pcs

STEAM STERILIZATION AT LOW TEMPERATURESSGMSU/6 Spore strips with B.subtilis „5230“ 10x6 ATCC 5230, Pack/100pcs

CLO2 STERILIZATIONACD/6 Sterilization strips chlorine dioxide with spores B.atrophaeus 10x6 ATCC 9372. Pack/100pcs

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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.

STEAM STERILIZATION Incubation: 24 h, 55-60°C

EZS/5 EZTest Steam with spores G stearothermophilus 10x5 ATCC 7953, Pack/100 pcs.

EZS/525 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 Smart-Read EZTest steam test pack G stearothermophilus 10x5 ATCC 7953, Pack/25pcs + 25nc

SRSP6/25 Smart-Read EZTest steam test pack G stearothermophilus10x6 ATCC 7953, Pack/25pcs + 25nc

EO STERILIZATION

Incubation: 48 h, 35-39°CEZG/6 EZTest Gas with spores Bacillus atrophaeus 10x6 ATCC 9372, Pack/100 pcs.

EZG/625 EZTest Gas with spores Bacillus atrophaeus 10x6 ATCC 9372, Pack/25 pcs.

H2O2 STERILIZATION

Incubation: 24 h, 55-60°C, spores inoculated on the steel discEZH/5 EZTest H2O2 with spores G stearothermophilus 10x5 ATCC 7953 inoculated on the steel disc,

Pack/100 pcs

EZH/6 EZTest H2O2 with spores G stearothermophilus 10x6 ATCC 7953 inoculated on the steel disc, Pack/100 pcs.

CRUSHER / SGMWNL

EZTest chrusher

EXSPOSURE STERRADIncubation: 24 h, 55-60°C

EXPO/6 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

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Releasat® Rapid-Readout Color Change Culturing KitReleasat 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.

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 resultsSmall, conveniently-shaped ampoule ( 49mm x 11mm )Suitable for high temperature dry heat sterilization of instrumentation and depyrogenation

STEAM STERILIZATIONPM/100 TSB media with purple pH indicator, qt 3,6+/-0,2 ml in tubes 16x100 mm,

Pack of 100 tubes

DRY HEAT STERILIZATION /EO STERILIZATIONRG-100 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-3-6-1080P-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

DRY HEAT STERILIZATIONDH/50 Kit is made of:

• 50 ampoule with spores Bacillus atrophaeus 10x6 ATCC 9372• 50 tubes containing 4,0 ml cultural media

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MagnaAmp® self-contained biological indicatorMagnaAmp 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, 55-60°CMA/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 ProSpore ampule Geobacillus stearothermophilus 14.75mm x 52mm 10x4 ATCC 7953 Pak: 10/box

PS-4-50 ProSpore ampule Geobacillus stearothermophilus 14.75mm x 52mm 10x4 ATCC 7953 Pak: 50/box

PS-5-10 ProSpore ampule Geobacillus stearothermophilus 14.75mm x 52mm 10x5 ATCC 7953 Pak: 10/box

PS-5-50 ProSpore ampule Geobacillus stearothermophilus 14.75mm x 52mm 10x5 ATCC 7953 Pak: 50/box

PS-6-50 ProSpore ampule Geobacillus stearothermophilus 14.75mm x 52mm 10x6 ATCC 7953 Pak: 50/box

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SterilAmp® II "5230"

STEAM STERILIZATION AT LOW TEMPERATURES, 110-118°CIncubation: 72 h, 37°C

SASU SterilAmp with spores Bacillus subtilis “5230” 10x6 ATCC 35021 Pack of 100 indicators and 10 negative control.

SASUNC SASU SA/6 10 negative control..

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, 55-60°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 17MMSA18/6 SterilAmp with spores Geobacillus stearothermophilus 10x6 ATCC 7953

Pack of 100 indicators and 10 negative control.

SA18/NC50 SterilAmp with spores Geobacillus stearothermophilus10x5 ATCC 7953Pack of 100 indicators and 10 negative control.

SANC18 SA18/NC50 SA/6 10 negative control.

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Spore Suspension

Suspensions offered in a 40% ethanol solution or 100% deionized H2O. Some hydropho-bic 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.

GEOBACILLUS STEAROTHERMOPHILUS SSSE/3 Spore suspension Geobacillus stearothermophilus 10x3 ATCC 7953 /0.1 ml / Pack-vial 10 ml / 40% Ethanol

SSSE/4 Spore suspension Geobacillus stearothermophilus 10x4 ATCC 7953 /0.1 ml / Pack-vial 10 ml / 40% Ethanol

SSSE/5 Spore suspension Geobacillus stearothermophilus 10x5 ATCC 7953 /0.1 ml / Pack-vial 10 ml / 40% Ethanol

SSSE/6 Spore suspension Geobacillus stearothermophilus 10x6 ATCC 7953 /0.1 ml / Pack-vial 10 ml / 40% Ethanol

SSSE/7 Spore suspension Geobacillus stearothermophilus 10x7 ATCC 7953 /0.1 ml / Pack-vial 10 ml / 40% Ethanol

SSSA/7 Spore suspension Geobacillus stearothermophilus10x7 ATCC 7953 /0.1 ml / Pack-vial 10 ml/ Aqueous

BACILLUS ATROPHAEUSSSGE/4 Spore suspension Bacillus atrophaeus 10x4 ATCC 9372 /0.1 ml / Pack-vial 10 ml / 40% Ethanol

SSGE/5 Spore suspension Bacillus atrophaeus 10x5 ATCC 9372 /0.1 ml / Pack-vial 10 ml / 40% Ethanol

SSGE/6 Spore suspension Bacillus atrophaeus 10x6 ATCC 9372 /0.1 ml / Pack-vial 10 ml / 40% Ethanol

SSGE/7 Spore suspension Bacillus atrophaeus 10x7 ATCC 9372 /0.1 ml /Pack-vial 10 ml / 40% Ethanol

SSGE/8 Spore suspension Bacillus atrophaeus 10x8 ATCC 9372 /0.1 ml / Pack-vial 10 ml / 40% Ethanol

BACILLUS PUMILUSSSRE/4 Spore suspension Bacillus pumilus 10x4 ATCC 27142 /0.1 ml / Pack-vial 10 ml / 40% Ethanol

SSRE/5 Spore suspension Bacillus pumilus 10x5 ATCC 27142 /0.1 ml / Pack-vial 10 ml / 40% Ethanol

SSRE/6 Spore suspension Bacillus pumilus10x6 ATCC 27142 /0.1 ml / Pack-vial 10 ml / 40% Ethanol

SSRE/7 Spore suspension Bacillus pumilus 10x7 ATCC 27142 /0.1 ml / Pack-vial 10 ml/ 40% Ethanol

SSRE/8 Spore suspension Bacillus pumilus 10x8 ATCC 27142 /0.1 ml / Pack-vial 10 ml/ 40% Ethanol

BACILLUS SUBTILIS “6633”SS6633E/4 Spore suspension Bacillus subtilis”6633” 10x4 ATCC 6633 /0.1 ml / Pack-vial 10 ml / 40% Ethanol

SS6633E/5 Spore suspension Bacillus subtilis”6633” 10x5 ATCC 6633 /0.1 ml / Pack-vial 10 ml / 40% Ethanol

SS6633E/6 Spore suspension Bacillus subtilis”6633” 10x6 ATCC 6633 /0.1 ml / Pack-vial 10 ml / 40% Ethanol

SS6633E/7 Spore suspension Bacillus subtilis”6633” 10x7 ATCC 6633 /0.1 ml / Pack-vial 10 ml / 40% Ethanol

SS6633E/8 Spore suspension Bacillus subtilis”6633” 10x8 ATCC 6633 /0.1 ml / Pack-vial 10 ml / 40% Ethanol

SS6633A/7 Spore suspension Bacillus subtilis”6633”10x7 ATCC 6633 /0.1 ml / Pack-vial 10 ml / Aqueous

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BACILLUS SUBTILIS “5230”SS5230E/4 Spore suspension Bacillus subtilis “5230”10x4 ATCC 35021 /0.1 ml / Pack-vial 10 m / 40% Ethanol

SS5230E/5 Spore suspension Bacillus subtilis “5230”10x5 ATCC 35021 /0.1 ml / Pack-vial 10 m / 40% Ethanol

SS5230E/6 Spore suspension Bacillus subtilis “5230”10x6 ATCC 35021 /0.1 ml / Pack-vial 10 m / 40% Ethanol

SS5230E/7 Spore suspension Bacillus subtilis “5230”10x7 ATCC 35021 /0.1 ml / Pack-vial 10 m / 40% Ethanol

SS5230E/8 Spore suspension Bacillus subtilis “5230”10x8 ATCC 35021 /0.1 ml / Pack-vial 10 m / 40% Ethanol

SS5230A/7 Spore suspension Bacillus subtilis “5230” 10x7 ATCC 35021 /0.1 ml / Pack-vial 10 m/Aqueous

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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

STEAM STERILIZATION

S1X25/6 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 7953In 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 7953In Glassine / 100 strips pack

SU1x25/6 Strip 1 x 25 mm with spores B. Subtilis 5230 10x6 ATCC 35021, Pack/ 100 strips/bulk

EO STERILIZATION / DRY HEATA1x25/6 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

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Steel discsSteel 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-

GEOBACILLUS STEAROTHERMOPHILUS, STEAM AND H2O2

HMV-091E3 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 Discs with spores G.stearothermophilus 10x4 ATCC 12980, Tyvek/Tyvek Pack/100 pcs

SBC-327 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 Steel discs with spores B. atropheus 10x3 ATCC 9372, Tyvek/Tyvek Pack/100 pcs

GRS-090 Steel discs with spores B. atropheus 10x6 ATCC 9372 , Tyvek/Tyvek Pack/100 pcs

NAS-152E3 Steel discs with spores G.stearothermophilus 10x3 ATCC 7953, Tyvek/Tyvek Pack/100 pcs

NAS-152 Steel discs with spores G.stearothermophilus 10x6 ATCC 7953, Tyvek/Tyvek Pack/100 pcs

BMWK-750 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/100 TSB media for HMV-091, KCD-404 i LOG-456

MICRO STRIPS1-6100TT Cotton Thread 19mmx1.5mm, Bacillus atrophaeus, 10x6 ATCC 9372,Tyvek/Tyvek Pack/100 pcs/bulk

1-6100YT Polyester Suture 5 cm x0.15Dia Bacillus atrophaeus, 10x6 ATCC 9372, Tyvek/Tyvek Pack/100 pcs/bulk

3-6100YT Cotton Thread 5 cm x0.15Dia G.stearothermophilus, 10x6 ATCC 9372, Tyvek/Tyvek Pack/100 pcs/bulk

1-10006 Paper Discs 6mm, Bacillus atrophaeus, 10x6 ATCC 9372, Pack/1000 pcs/bulk

DS6R/6 Paper Discs 6mm, G.stearothermophilus, 10x6 ATCC 7953,Pack/100 pcs/bulk

1-1000PB Paper Discs 9mm, Bacillus atrophaeus, 10x6 ATCC 9372, Pack/1000 pcs/bulk

3-6100PB Paper Discs 9mm, G.stearothermophilus, 10x6 ATCC 7953, Pack/1000 pcs/bulk

TSB-BP16 Paper Discs 6mm, G.stearothermophilus, 10x6 ATCC 7953, Pack/100 pcs/bulk

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PROLINE PCD

PL-3-6-15 PCD, G.stearothermophilus, 10x6 ATCC 7953, Pack/15

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Incubators for EZTest and MagnaAmp biological indicatorsModel 1410 Features:• Thirteen (13) individually numbered incubation cavities.• Integrated thermometer for easy temperature reference.• Activation cavity for activating (crushing) crushable self-contained 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

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:.

INKUBATORII 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

P6-1000 Power

9505-1410 Termometer, 1410

9505-1480 Termometer, 1480

9505-1510 Termometer, 1510

POPULATION ASSAY KIT

PAK Kit :4 x (19,50 x 145 mm) sterile flat-bottom tubes4 x 6 mm glass beads 12 x (16 x 125 mm) sterile dilution blank tubes8 x 1ml pipettes8 x 2ml pipettes2 x 5ml pipettes

PAK-M 1 x 240 ml media

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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)• CertificateofAnalysisVerification• BI Culturing• PopulationDetermination• Identification/PurityTesting• D-valueTesting(Steam,EO,DryHeat,H2O2• z-valueTesting• SurvivalKillVerificationCustomBIDevelopment• AmpouleFillingforSelf-ContainedBIs• BIDevelopmentforNovelSterilizationProcess• InoculationofClientProvidedSubstrate• PopulationandResistanceCharacterizationPharmaceutical• Solutions(D-value,Z-value,andBioburdenTesting)• Stopper/Septa(D-value/Z-valueTesting)• CustomInoculationforSterilizationCycleValidationStudiesSteamAutoclaveTesting

SERVICESBI Contract Testing Services

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CHEMICALINDICATORS

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CHEMICAL INDICATORSSteriTec 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!.

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..

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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.

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BOWIE-DICK PRODUCTS

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BOWIE-DICK GREEN CARD BD 117

Pack/ 120 cards3,5 min / 134°CISO 11140-4Class 2, EN ISO 11140-4

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 11140-5

Unexposed

Pass

Fail— Medium Fault Pass—Water spray

Pass

Fail—Large Fault

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BOWIE-DICK PRODUCTS

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BOWIE-DICK PROIZVODI

BOWIE-DICK TEST LIST BD 110 3,5 min / 134°C Pakiranje: 100 listova/pak Klasa 2

Zadovoljava Nezadovoljava

BOWIE-DICK GREEN CARD T BD 120 3,5 min / 134°C Pakiranje: 15 kom/pak Klasa2

Zadovoljava Nezadovoljava

BOWIE-DICK PROIZVODI

BOWIE-DICK TEST LIST BD 110 3,5 min / 134°C Pakiranje: 100 listova/pak Klasa 2

Zadovoljava Nezadovoljava

BOWIE-DICK GREEN CARD T BD 120 3,5 min / 134°C Pakiranje: 15 kom/pak Klasa2

Zadovoljava Nezadovoljava

PASS FAIL

PASS FAIL

BOWIE-DICK TEST SHEETBD 110

3,5 min / 134°CPakiranje: 100 sheets/paclClass 2, EN 150 11140-1, ISO 11140-3Color change: from blue to black

BOWIE-DICK- TEST PACKCI-BDTLF-203,5 min / 134°CPakiranje: 120 test pack/ boxClass 2Color change: from blue to black

BOWIE-DICK GREEN CARD TBD 120

3,5 min / 134°CPack: 15 pcs/packClass 2, EN867-5

Color change: from purple to green

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STEAM STERILIZATION

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CI 108/ 121-134Steam 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: 250pcsClass 5 (EN 867-1 , ISO 11140-1, AAMI ST60).

CHEMICALINDICATORS

Unexposed Pass

Excessive Fail

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STEAM STERILIZATION

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CT3310MM 19X55 CT3310MM 25X55

Steam Autoclave Tape

Color change: from white to brown/blackDimensions: 25 mm x 55m (CT3310MM 25X55)Dimensions 19 mm x 55 m (CT3310MM 19X55))Class 1, ISO 11140-1ISO 11140-1

CROSS-CHECKS LCI 111

9,5 min / 121°C3,5 min / 132°C3 min / 134°C

Pack: 250pcsClass 4, EN ISO 11140-1Color change: from yellow to brown/black

CHEMICALINDICATORS

PASS

CROSS-CHECKSCI 107

9 min / 121°C 2,5 min / 134°C Pack: 250pcsColor change: from yellow to brown/blackClass 4

PASS

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STEAM STERILIZATION

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CROSS-CHECKS LSCI 13912 min / 121°C5 min / 134°CPack: 250 pcsClass 4Purple to green ink technology.

CROSS-CHECKS SCI 1342,5 min / 134°CPack: 250 pcsClass 4Color change: from blue to black

STERI-VAPEUR 18CI 1174 MIN—4 min / 134°C— Class 418 MIN—19 min / 134°C—Class 6

INTEGRAPHCI 10112 min / 121°C3,5 min / 134°CPack: 250 pcsClass 5Color change: from purple to green

First field—Process indicatorMiddle field—IntegratorShort field—Extended cycle

FAILPASS

FAILPASS

Unexposed

PASS FAIL Pass—extended cycle

EXTENDED CYCLE FAIL

PASS

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STEAM STERILIZATION

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Unexposed

EMU-GRAPH A(Adhesive)CI 15010 min/121°C4 min/134°CClass 6Pack: 250pcs

EMU-GRAPH A(Adhesive)CI 15213 min /121°C5,3 min / 134°CClass 6Pack: 250pcs

EMU-GRAPH A(Adhesive)CI 15318,5 min /121°C7 min/134°CClass 6Pack: 250pcs

FAILPASS

EMU-GRAPH 5CI 14116 min /121°C6,5 min/134°CClass 6, Pack: 250pcs

EMU-GRAPH 7CI 14218,5 min/121°C7 min/134°CClass 6, Pack: 250pcs

FAILPASS

EMU-GRAPH CI 144/INT4 min/134°CClass 6, Pack: 250pcs

EMU-GRAPH 9CI 15722 min/121°C9 min/134°CClass 6, Pack: 250pcs

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DRC HEAT STERILIZATION

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CHEMICALINDICATORS

CHEMICAL INDICATORS FOR ETHYLENE OXIDE GAS STERILIZATION

FAILPASS

CI 124 EO Tape19 mm x 55 mColor change: from brown to green600mg/l EO, 40-60% RH, 54.5 °C- 45min +/- 5 min.

CROSS-CHECK EOCI 106130°F, 45-60%., 600mg/LPack: 250pcsClass 4Color change: from yellow to brown

CROSS-CHECKS P H2O2CI 115Pack: 250pcsClass 1Color change: from blue to pink

PASS

INDICATOR—DRY HEAT STERILIZATIONCI 11310 (+/-2) min. /160 °CPack: 1000 labelsClass 4

DRY HEAT INDIKATORCI 13610 (+/-2) min. /160 °CPack: 250pcsClass 4

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FORMALDEHYDE STERILIZATIONS

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HOLLOW LOAD PROCESS CHALLENGE DEVICES

CROSS-CHECKS FC118Pack: 250pcsClass 4EN ISO 11140-1Color change: from red to green FAILPASS

HELIPAC HOLLOW LOAD TESTLT 102/121First rectangle—5 min/121°CSecond rectangle—15 min/ 121°CLT 102/134First rectangle—1,7 min/134°CSecond rectangle—5 min/134°CLT 102/18First rectangle—5 min/134°CSecond rectangle—18 min/ 34°CClass 2

HELI-CHECK HOLLOW LOAD PCDLT104Pack: 250pcs + 1 pcd

3,5 min / 134°C5,3 min / 134°C7 min / 134°C

18 min / 134°C

PASS

FAIL

PASS

FAIL

FAILPASS

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WASHING MONITORS

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INDICATORS FOR WASH PHASE IN WASHER-DISINFECTORS

HOSPITAL WASHER— DISINFECTOR CONTROL

WASH-CHECKSWC101

WASH-CHECKS HWC105

ULTRASONIC CLEANER

PASS

FAIL

WASH-CHECKS ULTRASONICWC 108

WASH-CHECKS UHWC 110

PASS

FAIL

Pack: 100pcs

Pack: 100pcs

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WASH– CHECKS PRO WC112

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RETORT-CHECKS RC101

A food processing indicator

Color change: from purple to greenPack: 250pcs

RETORT CHECKS

Retort Checks-B /121,1°C 6 min Retort Checks-C /121,1°C 15 minRetort Checks-D /121,1°C 25 minRetort Checks-E /121,1°C 35 minRetort Checks-F /121,1°C 45 minRetort Checks-G /121,1°C 60 minRetort Checks-H /121,1°C 95 min

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Put za Forticu 12/c, Opatija HrvatskaTel: +385/(0)51 603 025 Fax: +385/(0)51 603 [email protected] www.sopex.hr

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Steritec Products Inc.