Biological indicators catalog -...

__________________________________________________________________________ SOPEX d.o.o. Biological indicators catalog

SOPEX d.o.o.

Put za forticu 12 c, Opatija

51211 Matulji Croatia

Tel: +385 (0)51 603 025 Fax: +385 (0)51 603 024

E-mail: [email protected]

www.sopex.hr


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 • 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

"MesaLabs is dedicated to manufacturing quality products

and providing our customers with the service and satisfaction they deserve."

For all information, please contact:

SOPEX d.o.o.

Put za forticu 12c, Opatija 51211 Matulji, Croatia

Tel: +385.(0)51.603025 Fax: +385.(0)51.603024

E-mail: [email protected] www.sopex.hr

SOPEX O p a t i j a Croatia


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Smart-Read EZTest® Biological Indicator

Monitoring System

Newly Released 1710 Smart-Well® Incubator

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 us-es a real biological indicator (BI) — with no added enzyme or chemical integrator — which is in-cubated, evaluated, and documented in one simple, automated operation. Relying only upon bacte-rial 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 organiza-tion with minimal training and validation.

• Fast biological results

• True biological system

• Easy one-step evaluation

• Automatic documentation

• Alarm on sterilization failure

• 100% verifiable results


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.

Steam Sterilization – Hospital packs

5-5025

25 Envelopes (Tests) – Each test consists of three spore strips – two to be placed in the sterilizer and one control. The two strips exposed in the sterilizer are to be returned to the envelope with the unexposed strip and all three are to be sent to the hospital micro lab for in-house culturing. The envelope has space for the technician to write pertinent information about the sterilizer load, contents and test results. Available with G. stearothermophilus, B. atrophaeus, or Combined species strips.

Steam Sterilization

SGMS/5 Spore strips with Geobacillus stearothermophilus 10x5 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.

Sterilization EO and Dry Heat

SGMG/6 Spore strips with Bacillus atrophaeus 10x6 ATCC 9372, Pack/100pcs

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


SGMSU/6 Spore strips with B.subtilis „5230“ 10x6 ATCC 35021, Pack/100 pcs

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

Steam sterilization, EO or Dry Heat - DUOSPORE

SGMD/56

Spore strips with Geobacillus stearothermophilus 10x5 ATCC 7953 and Bacillus atrophaeus 10x6 ATCC 9372, Pack/100 pcs

SGMD/66



Radiation sterilization

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



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 at low temperatures

SGMLF/6 Sterilization strips formaldehyde with spores G.stearothermophilus 10x6 ATCC 7953. Pack/100pcs

ClO2 sterilization

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

Steam Sterilization /Flash 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. stearothermophilus 10x5 ATCC 7953, Pack/25 pcs.

EZS/6 EZTest Steam with spores G. stearothermophilus 10x6 ATCC 7953, Pack/100 pcs .


SEZS/5 EZTest Steam with spores G. stearothermophilus 10x5 ATCC 7953 With dubble activator for fast reading. Pack/100 pcs.


EO Sterilization Incubation: 48 h, 35-39°C

EZG/6 EZTest Gas with spores Bacillus atrophaeus 10x6 ATCC 9372, Pack/100 pcs.



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.

The color indicator provides visual results within 24 hours (steam), 48 hours (chlorine dioxide) or 72 hours (EO / DRY) 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.

• 24 hour results (steam) / 48 hour results (ClO2) / 72 hour results (EO)

H2O2 Sterilization Incubation: 24 h, 55-60°C, spores inoculated on the steel disc

EZH/5 EZTest H2O2 with spores G stearothermophilus 10x5 ATCC 7953 inoculated on the steel disc, Pack/100 pcs.


EZH/625 EZTest H2O2 with spores G stearothermophilus 10x6 ATCC 7953, Pack/25 pcs.

Propylene Oxide Sterilization

Incubation: 24 h, 55-60°C

EZP/5

EZTest PPO SCBI with spores G. stearothermophilus 10x5 ATCC 7953,

Steam Sterilization

RS6-100

Kit is made of : • 100 Spore strips G. stearothermophilus 10x6 ATCC 7953 • 100 tubes with special media.

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

ClO2 Sterilization

RCD/50 Kit is made of: • 50 Spore strips Bacillus atrophaeus 10x6 ATCC 9372 • 50 tubes with special media

Dry heat Sterilization / EO Sterilization

RG-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.


DriAmp®

The unique DriAmp® biological indicator is appropriate for either high tem-perature direct air exposure or submersion in oils and other non-water based so-lutions where traditional paper strip indicators are difficult to use.The Dri-Amp® BI is a 1 ml snap-top glass ampoule containing silica material inoculat-ed with 106 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 manu-facture of aseptically filled pharmaceutical liquids.

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 ad-vantage of a 72 hour reduced incubation time compared to 7 days with competing products. Test re-sults are obtained during incubation by observing the medium which changes color from red-orange to yellow if any spores have survived the process. 72 hours results Small, conveniently-shaped ampoule ( 49mm x 11mm ) Suitable for high temperature dry heat sterilization of instrumentation and depyrogenation.

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 Small (1ml), conveniently shaped ampoule, Designed to sink in container

Negative controls are included with each box of product..

Steam sterilization Incubation 48 h, 55-60°C

MA/5 MagnaAmp with spores Geobacillus stearothermophilus 10x5 ATCC 7953 Pack of 50 indicators and 10 negative control.


Dry heat Sterilization

DA/6

Kit is made of: • 50 ampoule with spores Bacillus atrophaeus 10x6 ATCC 9372 • 50 tubes containing 4,0 ml cultural media


SterilAmp II® self-contained biological indicator

Steam Sterilization


SA/5 SterilAmp with spores Geobacillus stearothermophilus 10x5 ATCC 7953 Pack of 100 indicators and 10 negative control.

SterilAmp® II "5230"

Steam Sterilization at low temperatures, 105-115°C Incubation: 72 h, 37°C

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

SterilFlex™

SterilFlex is a glass-free, liquid submersible biological indicator (BI) designed specifically for pharmaceutical manufacturers and manufacturers of thermally processed food products. The SterilFlex™ BI is safe, rugged, and small enough to be placed into a can for retort processing or directly into a thermal continuous flow system. The SterilFlex BI consists of calibrated spore-forming microorganisms suspended in a specially formulated culture medium sealed in a small, flexible-plastic capsule. Designed to be easy to use, the SterilFlex BI requires no special laboratory processing and provides visual color-change results after only 48 hours of incubation. If any spores survive the process, the culture medium turns a dramatic yellow. Changes color from purple to yellow

Steam Sterilization Incubation: 48 h, 55-60°C

SF/6 SterilFlex with spores Geobacillus stearothermophilus 10x6 ATCC 7953 Pack of 100 indicators and 10 negative control



SterilAmp II is a compact, self-contained biological indicator for monitoring in-dustrial steam (121°C) sterilization of liquids in small containers. SterilAmp II precisely integrates the process lethality. SterilAmp II contains a specially for-mulated 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.


EZTest® Biological Test Packs (Process Challenge Devices) The EZTest Biological Test Pack is a small, convenient, FDA 510(k) notified product containing EZTest self-contained biological indicators. Designed to parallel the performance of the AAMI Test Pack, each pack includes a record card with a chemical integrator. EZTest Biological Test Packs (PCDs) are available in a pouch for EO sterilization, and a box (about the size of a deck of playing cards) for steam sterilization.


STP/05 Test Pack EZTest Steam with spores G. stearothermophilus 10x5.Pack/ 25 tests and 25 control.

STP/25 EZTest Steam Test Pack with spores G. stearothermophilus 10x5. Pack/ 25 tests and 25 control.


ETP/05 EZTest EO Test Pack with spores Bacillus atrophaeus 10x6. Pack/ 25 tests and 25 control. ETP/25 EZTest EO Test Pack with spores Bacillus atrophaeus 10x6. Pack/ 25 tests and 25 control..

Spore Suspension

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 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.

Steam Sterilization SSS/3 Spore suspension Geobacillus stearothermophilus 10x3 ATCC 7953 SSS/4 Spore suspension Geobacillus stearothermophilus 10x4 ATCC 7953 SSS/5 Spore suspension Geobacillus stearothermophilus 10x5 ATCC 7953 SSS/6 Spore suspension Geobacillus stearothermophilus 10x6 ATCC 7953 SSS/7 Spore suspension Geobacillus stearothermophilus 10x7 ATCC 7953

Dry heat or EO sterilization SSG/4 Spore suspension Bacillus atrophaeus 10x4 ATCC 9372 SSG/5 Spore suspension Bacillus atrophaeus 10x5 ATCC 9372 SSG/6 Spore suspension Bacillus atrophaeus 10x6 ATCC 9372 SSG/7 Spore suspension Bacillus atrophaeus 10x7 ATCC 9372 SSG/8 Spore suspension Bacillus atrophaeus 10x8 ATCC 9372

Radiation Sterilization SSR/4 Spore suspension Bacillus pumilus 10x4 ATCC 27142 SSR/5 Spore suspension Bacillus pumilus 10x5 ATCC 27142 SSR/6 Spore suspension Bacillus pumilus 10x6 ATCC 27142 SSR/7 Spore suspension Bacillus pumilus 10x7 ATCC 27142 SSR/8 Spore suspension Bacillus pumilus 10x8 ATCC 27142


Spores Clostridium sporogenes SSCS/3 Spore suspension Clostridium sporogens 10x3 ATCC 19404; 11437; 7955. SSCS/4 Spore suspension Clostridium sporogens 10x4 ATCC 19404; 11437; 7955. SSCS/5 Spore suspension Clostridium sporogens 10x5 ATCC 19404; 11437; 7955. SSCS/6 Spore suspension Clostridium sporogens 10x6 ATCC 19404; 11437; 7955.

SSCS/7 Spore suspension Clostridium sporogens 10x7 ATCC 19404; 11437; 7955.

Spores Bacillus subtilis “6633” SS6633/4 Spore suspension Bacillus subtilis”6633” 10x4 ATCC 6633 SS6633/5 Spore suspension Bacillus subtilis”6633” 10x5 ATCC 6633 SS6633/6 Spore suspension Bacillus subtilis”6633” 10x6 ATCC 6633 SS6633/7 Spore suspension Bacillus subtilis“6633” 10x7 ATCC 6633 SS6633/8 Spore suspension Bacillus subtilis”6633” 10x8 ATCC 6633

Spores Bacillus subtilis SSA/4 Spore suspension Bacillus subtilis 10x4 ATCC DSM4181 SSA/5 Spore suspension Bacillus subtilis 10x5 ATCC DSM4181 SSA/6 Spore suspension Bacillus subtilis 10x6 ATCC DSM4181 SSA/7 Spore suspension Bacillus subtilis 10x7 ATCC DSM4181

SSA/8 Spore suspension Bacillus subtilis 10x8 ATCC DSM4181

Spores Bacillus subtilis “5230” SS5230/4 Spore suspension Bacillus subtilis “5230”10x4 ATCC 35021 SS5230/5 Spore suspension Bacillus subtilis “5230”10x5 ATCC 35021 SS5230/6 Spore suspension Bacillus subtilis “5230”10x6 ATCC 35021 SS5230/7 Spore suspension Bacillus subtilis “5230”10x7 ATCC 35021 SS5230/8 Spore suspension Bacillus subtilis “5230”10x8 ATCC 35021

Spores Bacillus megaterium SSM/4 Spore suspension Bacillus megaterium 10x4 ATCC 14581 SSM/5 Spore suspension Bacillus megaterium 10x5 ATCC 14581 SSM/6 Spore suspension Bacillus megaterium 10x6 ATCC 14581 SSM/7 Spore suspension Bacillus megaterium 10x7 ATCC 14581 SSM/8 Spore suspension Bacillus megaterium 10x8 ATCC 14581

Spores Bacillus cereus SSBC/4 Spore suspension Bacillus cereus 10x4 ATCC 14579/11778 SSBC/5 Spore suspension Bacillus cereus 10x5 ATCC 14579/11778 SSBC/6 Spore suspension Bacillus cereus 10x6 ATCC 14579/11778 SSBC/7 Spore suspension Bacillus cereus 10x7 ATCC 14579/11778

SSBC/8 Spore suspension Bacillus cereus 10x8 ATCC 14579/11778

Spores Bacillus coagulens SSCO/3 Spore suspension Bacillus coagulens 10x3 ATCC 7050 SSCO/4 Spore suspension Bacillus coagulens 10x4 ATCC 7050 SSCO/5 Spore suspension Bacillus coagulens 10x5 ATCC 7050 SSCO/6 Spore suspension Bacillus coagulens 10x6 ATCC 7050

SSCO/7 Spore suspension Bacillus coagulens 10x7 ATCC 7050

Spores Bacillus smithii SSSM/3 Spore suspension Bacillus smithii 10x3 ATCC 51232 SSSM/4 Spore suspension Bacillus smithii 10x4 ATCC 51232 SSSM/5 Spore suspension Bacillus smithii 10x5 ATCC 51232 SSSM/6 Spore suspension Bacillus smithii 10x6 ATCC 51232

SSSM/7 Spore suspension Bacillus smithii 10x7 ATCC 51232


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.

Paper discs — inoculated with spores Paper discs (6mm and 9mm) 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.

Steam Sterilization Pack of 100 discs in a bulk

DS6x6S Square disc - 6 mm G. stearothermophilus 10x6 ATCC 7953 DS6R Round disc Ø 6 mm G. stearothermophilus 10x6 ATCC 7953

EO Sterilization or Dry heat

DA6x6S Square disc - 6 mm Bacillus atrophaeus 10x6 ATCC 9372 DA6R Round disc Ø 6 mm spores Bacillus atrophaeus 10x6 ATCC 9372

Radiation Sterilization

DP6x6S Square disc - 6 mm Bacillus pumilus 10x6 ATCC 27142 DP6R Round disc Ø 6 mm spores Bacillus pumilus 10x6 ATCC 27142 DPSS/6 Round disc Ø 12 mm spores Bacillus pumilus 10x6 ATCC 27142

Steam Sterilization Pack of 100 strips ina a bulk

S1X25 Strip 1 x 25 mm with spores G. stearothermophilus 10x6 ATCC 7953 S3x64 Strip 3 x 64 mm with spores G. stearothermophilus 10x6 ATCC 7953 S2x10 Strip 2 x 10 mm with spores G. stearothermophilus 10x6 ATCC 7953 S2x19 Strip 2 x 19 mm with spores G. stearothermophilus 10x6 ATCC 7953

EO Sterilization / Dry heat Pack of 100 strips ina a bulk

A1x25 Strip 1 x 25 mm with spores Bacillus atrophaeus 10x6 ATCC 9372 A3x64 Strip 3 x 64 mm with spores Bacillus atrophaeus 10x6 ATCC 9372 A2x10 Strip 2 x 10 mm with spores Bacillus atrophaeus 10x6 ATCC 9372 A2x19 Strip 2 x 19 mm with spores Bacillus atrophaeus 10x6 ATCC 9372

Radiation Sterilization Pack of 100 strips ina a bulk

P1x25 Strip 1 x 25 mm with spores Bacillus pumilus 10x6 ATCC 27142 P3x64 Strip 3 x 64 mm with spores Bacillus pumilus 10x6 ATCC 27142 P2x10 Strip 2 x 10 mm with spores Bacillus pumilus 10x6 ATCC 27142


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-center hole in the disc allows them to be removed from their package and suspended

throughout the isolator to insure proper flow.

Geobacillus stearothermophilus Pack/ 100 pcs in a package

HMV-091 Steel discs with spores G.stearothermophilus 10^6 ATCC 12980

KCD-404 Discs with spores G.stearothermophilus 10^4 ATCC 12980

SBC-327 Steel discs with spores G.stearothermophilus 10^6 ATCC12980.

LOG-456 Indicator “Tri-scale” with spores G.stearothermophilus 10^6, 10^5 and 10^4 ATCC 12980.

NAS-152 Steel discs with spores G.stearothermophilus 10^6 ATCC 7953

BMWK-750 Steril Tyvek Transfer Pocket with SBC-327

G.stearothermophilus 10^6- Steal “Coupon” Pack/ 100 pcs in a package

3-6100AT Steel card with spores G.stearothermophilus 10^6 ATCC7953.

3A-6100AT Steel card with spores G.stearothermophilus 10^6 ATCC12980.


G.stearothermophilus 10^6- Steal wires

3-6100WT Steel wires with spores G.stearothermophilus 10^6 ATCC 9372 Pack/ 100 pcs in a package. Lenght 19 mm without loop.

3-6100WT-L Steel wires with spores G.stearothermophilus 10^6 ATCC 9372 Pack/ 100 pcs in a package . Lenght 25 mm without loop.

Bacillus atrophaeus DASS/6

Discs Ø 8 mm with spores Bacillus atrophaeus 10^6 ATCC 9372 Pack/ 100 pcs in a package.

Seria GPR Steel indicators inoculated with Bacillus atrophaeus ATCC 9372 10x4 – 10x7 On a reqest


Incubators for EZTest and MagnaAmp biological indicators

1410

The new Mesa Labs Incubator Model 1410 is an adjustable temperature unit offering 3 temperature settings, an integrated thermometer, an activation cavity, and a 60°C temperature setting for inexpensive incubation of Smart-Read® EZTest® biological indicators for steam.

Model 1410 Features: • Thirteen (13) individually numbered incubation cavities. • Integrated thermometer for easy temperature reference. • Activation cavity for activating (crushing) crushable self-contained bi-

ological 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. Incubator dimenions: 9 (width) x 6,4 (hight) x 10 (depth) cm. Diameter of holes: • 1,111 cm incubator for MagnaAmp • 0,94 cm incubator for EZTest

Incubators

I 1410 Incubator with 14 holes for EZTest with digital termometer IMA-101 Incubator with 14 holes for MagnaAmp with digital termometer SWI-201 Incubator Smart-well with printer, thermometer, cable and book for archive IDT Digital Thermometer

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:

• Detailed population assay instructions • One (1) 250ml Wheaton bottle containing 240ml growth medium • Four (4) 19.5 x 145mm sterile flat-bottom tubes with four (4) 6mm glass beads • Twelve (12) 16 x 125mm sterile dilution blank tubes • Eight (8) 1ml pipettes • Eight (8) 2ml pipettes • Two (2) 5ml pipettes • Two (2) 10ml pipettes

PAK- Population Assay Kit

Also available

PAK-14 Kit for 4 confirmation of population spores PAK-M 1 x 240 ml media


SERVISES

“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

• Temperature Mapping

• Calibration

• Cycle Development


SOPEX d.o.o.



Tel: +385 (0)51 603 025 Fax: +385 (0)51 603 024


www.sopex.hr




Certification













SOPEX d.o.o.


Tel: +385.(0)51.603025 Fax: +385.(0)51.603024




Exp date

24

mon

ths

24

m

on

ths

24

m

on

ths

18

m

on

ths

18

m

on

ths

15

m

on

ths

24

mo

nth

s

24

m

on

ths

12

m

on

ths

18

mo

nth

s

9 m

on

ths

24

m

on

ths

24

m

on

ths

24

m

on

ths

24

m

on

ths

24

mo

nth

s

24

m

on

ths

24

mo

nth

s

24

m

on

ths

Incubation

7 d

55

-60

°C

7 d

55

-60

°C

7 d

55

-60

°C

48

h 5

5-6

0°C

48

h 5

5-6

0°C

7

2 h

35

-39

°C

24

h 5

5-6

0°C

7

d 5

5-6

0°C

2

4 h

6

0°C

7 d

55

-60

°C

7 d

30

-35

°C

7 d

30

-35

°C

7 d

30

-35

°C

48

h 3

5-3

9°C

72

h 3

7±

1°C

72

h 3

7±

1°C

7 d

30

-35

°C

7 d

30

-35

°C

24

h 5

5-6

0°C

Pack

10

0 s

trip

1

00

str

ip

Via

l 1

0 m

l 5

0 t

ests

+ 1

0 n

c

10

0 t

est.

+ 1

0 n

c 1

00

tes

t. +

10

nc

25

or

100

tes

ts

10

0 s

trip

1

00

ind

icat

ors

10

0 d

isc

1

00

str

ip

10

0 s

trip

V

ial

10

ml

25

or

100

tes

ts

10

0 t

ests

5

0 t

ests

10

0 s

trip

V

ia 1

0 m

l

10

0 t

ests

Type of bacteria

G.

stea

roth

erm

op

hil

us

10

5 a

nd 1

06

G.

stea

roth

. i

B.

atr

op

ha

eu

s 10

6/1

06 a

nd

10

5/1

06

G.

stea

roth

. 1

03-1

06 u

0.1

ml

G.

stea

roth

erm

op

hil

us

10

5 a

nd 1

06

G.

stea

roth

erm

op

hil

us

10

5 a

nd 1

06

B.

sub

tili

s “5

23

0”

10

6

G.

stea

roth

erm

op

hil

us

10

5 a

nd 1

06

G.

stea

roth

erm

op

hil

us

10

6

G.

stea

roth

erm

op

hil

us

10

5 a

nd 1

06

G

. st

ea

roth

erm

op

hil

us

10

6

G

. st

ea

roth

erm

op

hil

us

10

3

B.

atr

op

ha

eus

10

6

G.

stea

roth

. e

B.

atr

oph

aeu

s 10

6/1

06 a

nd

10

5/1

06

B.

atr

op

ha

eus

10

4-1

08 i

n 0

.1 m

l

B.

atr

op

ha

eus

10

6

B.

atr

op

ha

eus

10

6

B

. a

tro

pha

eu

s 10

6

B.

pu

mil

us

10

6

B.

pu

mil

us

10

4-1

08 i

n

0.1

ml

G.

stea

roth

erm

op

hil

us

10

5


Str

ip S

GM

S

Du

al S

trip

SG

MD

Sp

ore

Su

spen

sio

n S

SS

M

agn

aAm

p M

A

Ste

rilA

mp

II

SA

S

teri

lAm

p I

I S

AS

U

EZ

Tes

t S

team

EZ

S

Str

ip S

GM

LF

Rel

easa

t cu

lt.s

et

RS

5/6

-10

0

HP

VD

/6

dis

c

HP

VD

/3

dis

c S

trip

SG

MG

Du

al S

trip

SG

MD

S

po

re S

usp

ensi

on

SS

G

EZ

Tes

t G

as E

ZG

Rel

easa

t R

S-1

00

Dri

Am

p

DA

Str

ip S

GM

R

Sp

ore

Su

spen

sio

n S

SR

EZ

Tes

t P

PO

E

ZP

/5

Sterilization

type

Steam

H2O2

EO or

Dry Heat

Radiation

Pasteurisation



Monitoring System















5-5025


Steam Sterilization












SGMD/56


SGMD/66







EZTest ®




ClO2 sterilization























EZP/5


Steam Sterilization

RS6-100



ClO2 Sterilization






DriAmp®










DA/6




Steam Sterilization






SterilFlex™
















Spore Suspension






Steel discs






















1410






Incubators





Also available



SERVISES





• BI Culturing




• z-value Testing







Pharmaceutical






• Calibration



SOPEX d.o.o.



Tel: +385 (0)51 603 025 Fax: +385 (0)51 603 024


www.sopex.hr




Certification













SOPEX d.o.o.


Tel: +385.(0)51.603025 Fax: +385.(0)51.603024




Exp date

24

mon

ths

24

m

on

ths

24

m

on

ths

18

m

on

ths

18

m

on

ths

15

m

on

ths

24

mo

nth

s

24

m

on

ths

12

m

on

ths

18

mo

nth

s

9 m

on

ths

24

m

on

ths

24

m

on

ths

24

m

on

ths

24

m

on

ths

24

mo

nth

s

24

m

on

ths

24

mo

nth

s

24

m

on

ths

Incubation

7 d

55

-60

°C

7 d

55

-60

°C

7 d

55

-60

°C

48

h 5

5-6

0°C

48

h 5

5-6

0°C

7

2 h

35

-39

°C

24

h 5

5-6

0°C

7

d 5

5-6

0°C

2

4 h

6

0°C

7 d

55

-60

°C

7 d

30

-35

°C

7 d

30

-35

°C

7 d

30

-35

°C

48

h 3

5-3

9°C

72

h 3

7±

1°C

72

h 3

7±

1°C

7 d

30

-35

°C

7 d

30

-35

°C

24

h 5

5-6

0°C

Pack

10

0 s

trip

1

00

str

ip

Via

l 1

0 m

l 5

0 t

ests

+ 1

0 n

c

10

0 t

est.

+ 1

0 n

c 1

00

tes

t. +

10

nc

25

or

100

tes

ts

10

0 s

trip

1

00

ind

icat

ors

10

0 d

isc

1

00

str

ip

10

0 s

trip

V

ial

10

ml

25

or

100

tes

ts

10

0 t

ests

5

0 t

ests

10

0 s

trip

V

ia 1

0 m

l

10

0 t

ests

Type of bacteria

G.

stea

roth

erm

op

hil

us

10

5 a

nd 1

06

G.

stea

roth

. i

B.

atr

op

ha

eu

s 10

6/1

06 a

nd

10

5/1

06

G.

stea

roth

. 1

03-1

06 u

0.1

ml

G.

stea

roth

erm

op

hil

us

10

5 a

nd 1

06

G.

stea

roth

erm

op

hil

us

10

5 a

nd 1

06

B.

sub

tili

s “5

23

0”

10

6

G.

stea

roth

erm

op

hil

us

10

5 a

nd 1

06

G.

stea

roth

erm

op

hil

us

10

6

G.

stea

roth

erm

op

hil

us

10

5 a

nd 1

06

G

. st

ea

roth

erm

op

hil

us

10

6

G

. st

ea

roth

erm

op

hil

us

10

3

B.

atr

op

ha

eus

10

6

G.

stea

roth

. e

B.

atr

oph

aeu

s 10

6/1

06 a

nd

10

5/1

06

B.

atr

op

ha

eus

10

4-1

08 i

n 0

.1 m

l

B.

atr

op

ha

eus

10

6

B.

atr

op

ha

eus

10

6

B

. a

tro

pha

eu

s 10

6

B.

pu

mil

us

10

6

B.

pu

mil

us

10

4-1

08 i

n

0.1

ml

G.

stea

roth

erm

op

hil

us

10

5


Str

ip S

GM

S

Du

al S

trip

SG

MD

Sp

ore

Su

spen

sio

n S

SS

M

agn

aAm

p M

A

Ste

rilA

mp

II

SA

S

teri

lAm

p I

I S

AS

U

EZ

Tes

t S

team

EZ

S

Str

ip S

GM

LF

Rel

easa

t cu

lt.s

et

RS

5/6

-10

0

HP

VD

/6

dis

c

HP

VD

/3

dis

c S

trip

SG

MG

Du

al S

trip

SG

MD

S

po

re S

usp

ensi

on

SS

G

EZ

Tes

t G

as E

ZG

Rel

easa

t R

S-1

00

Dri

Am

p

DA

Str

ip S

GM

R

Sp

ore

Su

spen

sio

n S

SR

EZ

Tes

t P

PO

E

ZP

/5

Sterilization

type

Steam

H2O2

EO or

Dry Heat

Radiation

Pasteurisation



Monitoring System















5-5025


Steam Sterilization












SGMD/56


SGMD/66







EZTest ®




ClO2 sterilization























EZP/5


Steam Sterilization

RS6-100



ClO2 Sterilization






DriAmp®










DA/6




Steam Sterilization






SterilFlex™
















Spore Suspension






Steel discs






















1410






Incubators





Also available



SERVISES





• BI Culturing




• z-value Testing







Pharmaceutical






• Calibration


Biological indicators catalog -...

Documents

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