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Bowie - Dick Test Pack

BD test Paper & Holder


Steam Quality Test Kit
Sample Cooler

BD Test Paper & Holder

Bowie Dick Test Pack


Steam Quality Test Kit
Sample Cooler

ProChem BD121

Unexposed

Pass
Fail

BD test Paper & Holder


BD Test Pack

STERISCAN

All-In-One

Reusable Test Pack

One device. All of your Test Pack needs.

Biological Indicator, Chemical Indicator and Bowie Dick Test Pack All in One Device!
STERISCAN

CLASS 5/ ISO 11140-1:2005

STERISCAN Class 6
EMULATING INDICATOR

INTEGRATOR
S T E A M STERILIZATION
Dana Products, Inc. Franklin Park, Illinois USA
REJECT (NO)

ACCEPT (OK)

DARK BAR MUST ENTER ACCEPT WINDOW

STEAM

DARK BAR MUST


ENTER ACCEPT AREA

Effective: SteriScan Reusable Test Pack provides positive


BI survival past the half-cycle.

1
CLASS 6/ ISO 11140-1:2005
LOT 210 EXP. 2011/02

Dana Products, Inc.


Franklin Park, Illinois USA

ACCEPT

STERISCAN BOWIE-DICK TEST STRIP


Dana Products, Inc.
Franklin Park, Illinois USA

A I R R E M O VA L

Insert into SteriScan Test Pack

4
Dark bar must
cover window.

Save Money and the Environment: The SteriScan Reusable


Test Pack will generate significant cost and waste savings with
each use.

ISO 11140-4

LOT 212

EXP.

2015/02

Versatile: The SteriScan Reusable Test Pack can be used as a


Process Challenge Device with biological indicators and SteriScan
Class 5 and Class 6 chemical indicators, or as an Air Removal Test
with SteriScan Bowie-Dick indicators.

Rise Above Excessive Cost & Waste

Made in USA by: Dana Products, Inc. 11457 Melrose Street Franklin Park, IL 60131 www.danaproducts.com

Mesa Biological Indicators


Spore Strips

Spore Strips

Mesa Labs offers a complete line of spore strips for sterility testing in various sterilization
environments for both Healthcare and Industrial applications. In addition to our line of
spore strips, Mesa also manufactures prepared culture media specially formulated for use
with our spore products. Other forumlations are also available for various microbiological
tests.

Autoclave Validations
EO Sterilization
Steam Applications
Irradiation Sterilization
Multiple Species Available
Geobacillus stearothermophilus
For use in steam sterilization at 121.1C (250F) to
135C (275F), Low Temperature Steam w/Formaldehyde and Chemiclave. After exposure to sterilant,
incubate strips at 55-60C. 24-Hour incubation available when used with Mesas Culture Media.
Bacillus atrophaeus
For use in Ethylene Oxide (600mg/L), Dry Heat sterilization (D-value determined at 160C), and formaldehyde fumigation. After exposure to sterilant, incubate
strips at 30-35C.
Combined species spore strips
G. stearothermophilus (105) and B. atrophaeus (106) on each strip. For use in Steam, EO, Dry Heat or
Chemiclave sterilizers. In-house studies have shown the performance of dual species strips to be essentially
equivalent to single species strips made from the same spore batch.

Bacillus pumilus
Used for validation of irradiation sterilization processes. After exposure to sterilant, incubate strips at 3035C.

Ordering Information
Species

Min. Population

Log

G. stearothermophilus

100,000

10

G. stearothermophilus

1,000,000

106

B. atrophaeus

1,000,000

106

B. pumilus

1,000,000

106

Reduced Incubation Available

Mesa Laboratories, Inc.


www.MesaLabs.com
BIsales@mesalabs.com
Rev. 8.1.2013

Mesa Biological Indicators

ProTest for Steam, EO and H2O2

ProTest Self-Contained Biological Indicators for Steam, EO and H2O2


ProTest is a self-contained Biological Indicator for use in either Steam, Ethylene Oxide or
H2O2 sterilization. Each unit is made up of a plastic container with cap, a crushable glass
ampoule with recovery media, and either a paper strip (for steam and EO) or borosilicate
disc (for H2O2) inoculated with spores. ProTest is available for healthcare and industrial
use.

ProTest Steam
Intended for use in steam 121C gravity displacement cycles, and 121-135C prevacuum cycles. (10 minute 132C gravity displacement cycles, and 3 minute 132C
flash gravity displacement cycles.)
510(k) received for healthcare facilities

Contains G. stearothermophilus spores

24-hour incubation

Species

Catalog #

Min. Population

Qty/Box

G. stearothermophilus

PT-3-5-25

1.0 x 10

25

G. stearothermophilus

PT-3-6-25

1.0 x 10

25

G. stearothermophilus

PT-3-5-100

1.0 x 10

100

G. stearothermophilus

PT-3-6-100

1.0 x 10

100

5
6
5
6

ProTest EO

Intended for use in Ethylene Oxide 600mg/L, 54C, 60%RH

510(k) received for healthcare facilities

Contains B. atrophaeus spores

48-hour incubation

Species

Catalog #

Min. Population

Qty/Box

B. atrophaeus

PT-1-6-25

1.0 x 10

25

B. atrophaeus

PT-1-6-100

1.0 x 10

100

6
6

ProTest H2O2

Intended for use in the STERRAD Sterilization System1 (Industrial Use Only).

Contains G. stearothermophilus spores

24-hour incubation

Sterrad is a registered trademark of Advanced Sterilization Products.

Species

Catalog #

Min. Population

G. stearothermophilus

PTH-3-6-25

1.0 x 10

25

G. stearothermophilus

PTH-3-6-100

1.0 x 106

100

Qty/Box

Certification

Each lot of ProTest is certified for population, species, D-value, z-value (where applicable), purity and expiry.
Shelf life is 18 months from the date of manufacture. The above catalog numbers for ProTest comply with
AAMI/ISO 11138-1 and AAMI/ISO 11138-3.

Mesa Laboratories, Inc.


www.MesaLabs.com
BIsales@mesalabs.com
Rev. 4.9.2014

Mesa Biological Indicators

ProSpore Ampoule/ProAMP

Self-contained glass ampoules for steam sterilization


ProSpore Ampoule and ProAMP are self-contained biological indicators for steam
sterilization ideal for validating the sterilization of liquid loads, though they are also suitable
for loads containing dry goods. No activation is required.
Simply expose the unit to the sterilization process and incubate
afterwards. ProSpore Ampoule and ProAMP are validated for
48-hour reduced incubation.

ProSpore 4ml and 1ml Ampoules


510(k) received for use at 121C for healthcare facilities
Negative controls (NC) available for 1ml ampoules*
May be used between 118 - 135C*
Vivid purple to yellow color change

ProAMP
Intended for use with industrial steam sterilization
processes between 118 - 135C
Packaged with negative controls (NC)
Vivid purple to yellow color change

Negative Controls
The negative control is a media ampoule made from the same lot of media used to make
the corresponding spore ampoules. Negative controls are available for ProAMP and
ProSpore 1ml Ampoule.

Certification
Each lot of ProSpore/ProAMP is certified for population, species, D-value, z-value, purity
and expiry. Shelf life is 18 months from date of manufacture. ProAMP and ProSpore (log 5
and higher) comply with AAMI/ISO 11138-1 and AAMI/ISO 11138-3.
Industrial Use Only

Mesa Laboratories, Inc.


www.MesaLabs.com
BIsales@mesalabs.com

MesaLabs

ProSpore Ampoule/ProAMP

Specifications
ProSpore Ampoule is a hermetically sealed, type I borosilicate glass ampoule. The ampoule is filled with a modified Soybean Casein Digest Broth containing bromocresol purple
acid indicator. Each ampoule also contains a population of G. stearothermophilus spores.
ProSpore Ampoule has received 510(k) notification for sale to healthcare facilities with a
48-hour incubation period. Growth is evident by either turbidity and/or a color change from
a purple to or toward yellow. Expiration is 18 months from the date of manufacture.

Ordering Information

ProSpore Ampoule and ProAMP are refrigerated items and require overnight shipping. For
pricing information, please see current price list.

ProSpore 4ml Ampoule


Outer Diameter: 14.75mm +/- 0.15mm
Height: 52.0 - 55.0mm
Species

Catalog #

Min. Population

Qty/Box

G. stearothermophilus

PS-4-10

1.0 x 10

10

G. stearothermophilus

PS-4-50

1.0 x 10

50

G. stearothermophilus

PS-5-10

1.0 x 10

10

G. stearothermophilus

PS-5-50

1.0 x 10

50

G. stearothermophilus

PS-6-50

1.0 x 10

50

Catalog #

Min. Population

Qty/Box

G. stearothermophilus

PS1-4-15

1.0 x 104

15

G. stearothermophilus

PS1-4-100

1.0 x 10

100

G. stearothermophilus

PS1-5-15

1.0 x 10

15

G. stearothermophilus

PS1-5-100

1.0 x 10

100

G. stearothermophilus

PS1-6-15

1.0 x 10

15

G. stearothermophilus

PS1-6-100

1.0 x 10

100

G. stearothermophilus

PS1-5-60NC*

1.0 x 10

50 +10NC

G. stearothermophilus

PS1-6-60NC*

1.0 x 10

50 +10NC

4
4
5
5
6

ProSpore 1ml Ampoule


Outer Diameter: 10.75mm +/- 0.15mm
Height: 48.5 - 53.0mm
Species

4
5
5
6
6
5
6

ProAMP
Outer Diameter: 6.5mm +/- 0.2mm
Height: 25.0 - 28.0mm
Species

Catalog #

Min. Population

Qty/Box

G. stearothermophilus

PA-5-110NC

1.0 x 10

100 +10NC

G. stearothermophilus

PA-6-110NC

1.0 x 10

100 +10NC

Mesa Laboratories, Inc.


www.MesaLabs.com
BIsales@mesalabs.com

MesaLabs

5
6

Rev. 5.29.2012

Mesa Biological Indicators

DriAmp

Biological Indicator for Dry Heat

The unique DriAmp biological indicator (BI) is appropriate for either high temperature
direct air exposure or submersion in oils and other non-water
based solutions where traditional paper strip indicators are
difficult to use.
The DriAmp BI is a 1 mL snap-top glass ampoule containing
silica material inoculated with 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 manufacture 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
advantage of a 72-hour reduced incubation time compared to 7
days with competing products. Test results are obtained during
incubation by observing the medium which changes color from
red-orange to yellow if any spores have survived the process.

72-hour results

Small, conveniently-shaped ampoule (49mm x 11mm)

Suitable for high temperature dry heat sterilization of instrumentation and depyrogenation

Dramatic color change

Storage
Room Temperature.

Certification
DriAmp biological indicators are traceable to a recognized culture collection, and certified
for population, D-value, z-value, and performance.

Ordering Information
Species

B. atrophaeus

Mesa Laboratories, Inc.


www.MesaLabs.com
BIsales@mesalabs.com

Catalog #

Min. Population

Sets/Box

DH/50

1.0 x 106

50

MesaLabs

Rev. 5.29.2012

Mesa Biological Indicators

SterilAmp II 5230

Liquid Submersible SCBI for Low Temperature Steam


SterilAmp II 5230 is a compact, self-contained ampoule biological indicator for monitoring industrial low temperature (110 - 118C) steam sterilization of liquids in small containers.

26mm x 6.5mm

72-hour results
Small, conveniently-shaped ampoule
No laboratory required
Dramatic color change
PASS

FAIL

Packaged with 10 Negative Controls

SterilAmp II 5230 contains a specially formulated culture medium that turns a dramatic
yellow when spores grow, providing easy visual confirmation of sterilization within 72
hours, without the need for difficult and time-consuming laboratory work.

Storage
Refrigerate at 2-8C.

Certification
SterilAmp II 5230 biological indicators are traceable to a recognized culture collection and
certified for population, D-value, z-value, Fo value, and performance.

Ordering Information
Species

B. subtilis 5230

Mesa Laboratories, Inc.


www.MesaLabs.com
BIsales@mesalabs.com

Catalog #

Min. Population

Qty/Box

SASU/6

1.0 x 10

100 Tests / 10 NC

MesaLabs

Rev. 5.29.2012

Mesa Biological Indicators

SterilFlex

Glass-Free Liquid Submersible Biological Indicator


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.

Contains no glass or metal

Can be embedded in particles

Liquid Submersible

No laboratory required

For food or pharmaceutical applications

Dramatic color change

48-hour results

18 Month Expiry

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.

Storage
Refrigerate at 2-8C.

Certification
SterilFlex biological indicators are traceable to a recognized culture collection and certified for population, D-value, z-value and
performance.

Ordering Information
Species

G. stearothermophilus

Catalog #

Min. Population

Qty/Box

SF/6

1.0 x 106

100

Mesa Laboratories, Inc.


www.MesaLabs.com
BIsales@mesalabs.com
Rev. 4.16.2014

Mesa Biological Indicators

ProLine

ProLine Process Challenge Device

ProLine is a Biological Indicator system designed for use in the validation or monitoring of
sterilization cycles of tubing ranging from 1/8 to 5/8 tubing ID.
The ProLine PCD (Process Challenge Device) contains a filter
paper disc inoculated with bacterial spores of Geobacillus stearothermophilus (for Steam) or Bacillus atrophaeus (for EO). The
spore disc is packaged in a glassine envelope and is located in
the center of the ProLine housing. If adequate sterilant penetration occurs, the spores on the disc will be deactivated and verify
an adequate sterilization cycle.

Assembly
For a given length of tubing, the most difficult area to be sterilized is the mid-point of the tubing length. This is where the ProLine device must be
placed. To do this, a representative piece of tubing should be cut at its mid-point. The two
half lengths should now be attached to the ProLine device by slipping one end of each cut
length of tubing over the tapered ends of the ProLine device. The ProLine device is now
located in the most difficult area of the tubing to sterilize.

Use and Placement


The ProLine system with its two attached lengths of tubing should now be placed in the
sterilizer along with a normal load being processed where tubing would normally be included.

Post Sterilization Testing


Once the sterilization cycle is completed, the ProLine and attached lengths of tubing are
removed from the sterilizer chamber and transferred to an area where an aseptic transfer
of the spore disc to growth media can be performed. To do this, grasp both sides of the
ProLine device and break the chamber open exposing the glassine packaged spore disc.
The spore disc must now be transferred aseptically to a tube of sterile Tryptic Soy Broth
(TSB) and incubated for Growth/No Growth testing. The opened ProLine device halves can
now be discarded as the device is a single use only product.

Ordering Information
Species

Catalog #

Min. Population

Sets/Box

G. stearothermophilus

PL-3-6-15

1.0 x 106

15

B. atrophaeus

PL-1-6-15

1.0 x 10

15

Mesa Laboratories, Inc.


www.MesaLabs.com
BIsales@mesalabs.com

MesaLabs

Rev. 5.29.2012

Mesa Biological Indicators

Spore Suspensions

Spore Suspensions

Spore Suspensions are diluted aliquots from our primary spore crop (batch).
They are used to directly inoculate (and therefore challenge) a material or
solution with a known concentration of spores. US FDA requires medical device
and pharmaceutical manufacturers to challenge their products directly with
spores prior to approving them for sale. This challenge is intended to determine
if the devices carrier material or pharmaceuticals properties (viscosity, salt
content, etc.) has any sporicidal or preservative effect that will impact the
manufacturers ability to sterilize the product and to determine instructions on
how the user can sterilize the device if reusable.
Suspensions are offered in a 40% ethanol solution or 100% deionized 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.
Spore Suspensions are available for the following species in various populations.
B. atrophaeus*
B. subtilis* (#6633 and des. 5230)
G. stearothermophilus* (#7953, 12980, 10149)
B. thuringiensis*
B. pumilus*
B. cereus*
B. megaterium*
B. coagulans*
*Derived from recognized reference strains as specified within USP, ISO or EN guidelines. These products are
not certified as being representative of the reference strain and they should therefore not be used where a refref
erence culture is specified.

Mesa Laboratories, Inc.


www.MesaLabs.com
BIsales@mesalabs.com
Rev. 3.08.2013

Spore Suspensions

Ordering Information
B. atrophaeus Reference #9372
Catalog #
SUS-1-4
SUS-1-5
SUS-1-6
SUS-1-7
SUS-1-8
SUS-1-9

Population
(per 0.1ml)
Log 4
Log 5
Log 6
Log 7
Log 8
Log 9

B. subtilis Reference #6633


Catalog #
SUS-1A-4
SUS-1A-5
SUS-1A-6
SUS-1A-7
SUS-1A-8

Population
(per 0.1ml)
Log 4
Log 5
Log 6
Log 7
Log 8

B. subtilis Reference #35021 (des. 5230)


Catalog #
SUS-1B-4
SUS-1B-5
SUS-1B-6
SUS-1B-7

Population
(per 0.1ml)
Log 4
Log 5
Log 6
Log 7

G. stearothermophilus Reference #7953


Catalog #
SUS-3-4
SUS-3-5
SUS-3-6
SUS-3-7

Population
(per 0.1ml)
Log 4
Log 5
Log 6
Log 7

G.stearothermophilus Reference #12980


Catalog #
SUS-3A-4
SUS-3A-5
SUS-3A-6
SUS-3A-7

Population
(per 0.1ml)
Log 4
Log 5
Log 6
Log 7

G.stearothermophilus Reference #10149


Catalog #
SUS-3B-4
SUS-3B-5
SUS-3B-6
SUS-3B-7

Population
(per 0.1ml)
Log 4
Log 5
Log 6
Log 7

B. thuringiensis Reference #29730


Catalog #
SUS-6-6
SUS-6-7
SUS-6-8
SUS-6-9

Population
(per 0.1ml)
Log 6
Log 7
Log 8
Log 9

B. pumilus Reference #27142


Catalog #
SUS-7-4
SUS-7-5
SUS-7-6
SUS-7-7
SUS-7-8
SUS-7-9

Population
(per 0.1ml)
Log 4
Log 5
Log 6
Log 7
Log 8
Log 9

B. cereus Reference #11778


Catalog #
SUS-8-6
SUS-8-7
SUS-8-8
SUS-8-9

Population
(per 0.1ml)
Log 6
Log 7
Log 8
Log 9

B. megaterium Reference #8245


Catalog #
SUS-9-6
SUS-9-7
SUS-9-8
SUS-9-9

Population
(per 0.1ml)
Log 6
Log 7
Log 8
Log 9

B. coagulans Reference #51232


Catalog #
SUS-CG-6

Population
(per 0.1ml)
Log 6

Mesa Laboratories, Inc.


www.MesaLabs.com
BIsales@mesalabs.com
Rev. 3.08.2013

Mesa Biological Indicators

Smart-Read EZTest

Smart-Read EZTest Biological Indicator Monitoring System


The Smart-Read EZTest Biological Monitoring System allows an organization to release
sterile product with true biological confirmation faster and easier than ever before.
This unique system uses a real biological indicator (BI) -- with no added enzyme or chemical integrator -- which is incubated, evaluated, and documented in one simple, automated
operation. Relying only upon bacterial spore growth, the Smart-Read system can detect
sterilization failure in as few as three to five hours, and negative results can be confirmed with ten hours of incubation.

Fast biological results

True biological system

Easy one-step evaluation

Automatic documentation

Sterilization failure alarm

100% verifiable results

Ordering Information
Smart-Read EZTest SCBI
Species

Catalog #

Min. Population

Qty/Box

G. stearothermophilus

SEZS/5

1.0 x 10

100

G. stearothermophilus

SEZS/6

1.0 x 10

100

5
6

Smart-Read EZTest Biological Indicator Test Pack (PCD)

Catalog #

Min. Population

Qty/Box

G. stearothermophilus

SRSP/05

1.0 x 10

25 Tests / 5 Controls

G. stearothermophilus

SRSP/25

1.0 x 10

25 Tests / 25 Controls

Incubation Cells

Temperature

Catalog Number

United States

10 +1 control

60C

SWI1710-1

European

10 +1 control

60C

SWI1710-3

Australian

10 +1 control

60C

SWI1710-4

United Kingdom

10 +1 control

60C

SWI1710-5

Species

5
6

Smart-Well Incubator

Cord

Mesa Laboratories, Inc.


www.MesaLabs.com
BIsales@mesalabs.com
Rev. 4.01.2013

Mesa Biological Indicators

1510 Self-Contained Biological Indicator (SCBI) Incubator

1510 SCBI Incubator

The Mesa 1510 incubator is designed for convenient and effective incubation
of Mesa self-contained biological indicators at 57C including MagnaAmp and
ProSpore Ampoule 1mL liquid submersible biological indicators.

Convenient
Simultaneous incubation of up to 15 BIs in numbered incubation cavities.
Multinational 110V/220V power adapter with interchangeable blades.
Digital Temperature Display

User Friendly



Small footprint.
Fast warm up time (30-45 minutes).
Designed for 24-hour-a-day use.
Reliable operation.

Certifications
RoHS compliant, CSA C/US and CE Mark

Mesa Laboratories, Inc.


www.MesaLabs.com
BIsales@mesalabs.com
Rev. 4.9.2014

Mesa Biological Indicators

1410 Adjustable SCBI Incubator

1410 Adjustable Self-Contained Biological Indicator (SCBI) Incubator

The Mesa 1410 incubator is designed for convenient and effective incubation of Mesa selfcontained biological indicators at 37C (Bacillus atrophaeus ) or 57C and 60C (Geobacillus stearothermophilus ).

The incubator features a built-in thermometer with LED display, 13 incubation cavities and
an integrated activation (crushing) cavity.
Convenient
Simultaneous incubation of up to 13 BIs in numbered incubation cavities.
Multinational 110V/220V power adapter with interchangeable blades.
Incubation temperature adjustable for BIs containing B. atrophaeus (37C) or G.
stearothermophilus (57C and 60C).
Supports 10-hour Smart-Read BIs at 60C.
User Friendly
Integrated activation (crushing) cavity.
Very fast warm up time (10-15 minutes depending on selected temperature).
Designed for 24-hours-a-day use.
Integrated thermometer with digital display.
Certifications
RoHS compliant, CSA C/US and CE Mark.

Mesa Laboratories, Inc.


12100 W. 6th Avenue
Lakewood, CO 80228 USA

MesaLabs

Tel: +1-303-987-8000
www.MesaLabs.com
bisales@mesalabs.com

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