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ProChem BD121
Unexposed
Pass
Fail
STERISCAN
All-In-One
Biological Indicator, Chemical Indicator and Bowie Dick Test Pack All in One Device!
STERISCAN
STERISCAN Class 6
EMULATING INDICATOR
INTEGRATOR
S T E A M STERILIZATION
Dana Products, Inc. Franklin Park, Illinois USA
REJECT (NO)
ACCEPT (OK)
STEAM
1
CLASS 6/ ISO 11140-1:2005
LOT 210 EXP. 2011/02
ACCEPT
A I R R E M O VA L
4
Dark bar must
cover window.
ISO 11140-4
LOT 212
EXP.
2015/02
Made in USA by: Dana Products, Inc. 11457 Melrose Street Franklin Park, IL 60131 www.danaproducts.com
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
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
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
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).
24-hour incubation
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.
ProSpore Ampoule/ProAMP
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
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.
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
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
MesaLabs
5
6
Rev. 5.29.2012
DriAmp
The unique DriAmp biological indicator (BI) is appropriate for either high temperature
direct air exposure or submersion in oils and other non-water
based solutions where traditional paper strip indicators are
difficult to use.
The DriAmp BI is a 1 mL snap-top glass ampoule containing
silica material inoculated with 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
Suitable for high temperature dry heat sterilization of instrumentation and depyrogenation
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
Catalog #
Min. Population
Sets/Box
DH/50
1.0 x 106
50
MesaLabs
Rev. 5.29.2012
SterilAmp II 5230
26mm x 6.5mm
72-hour results
Small, conveniently-shaped ampoule
No laboratory required
Dramatic color change
PASS
FAIL
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
Catalog #
Min. Population
Qty/Box
SASU/6
1.0 x 10
100 Tests / 10 NC
MesaLabs
Rev. 5.29.2012
SterilFlex
Liquid Submersible
No laboratory required
48-hour results
18 Month Expiry
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
ProLine
ProLine is a Biological Indicator system designed for use in the validation or monitoring of
sterilization cycles of tubing ranging from 1/8 to 5/8 tubing ID.
The ProLine PCD (Process Challenge Device) contains a filter
paper disc inoculated with bacterial spores of Geobacillus stearothermophilus (for Steam) or Bacillus atrophaeus (for EO). The
spore disc is packaged in a glassine envelope and is located in
the center of the ProLine housing. If adequate sterilant penetration occurs, the spores on the disc will be deactivated and verify
an adequate sterilization cycle.
Assembly
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.
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
MesaLabs
Rev. 5.29.2012
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.
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
Population
(per 0.1ml)
Log 4
Log 5
Log 6
Log 7
Log 8
Population
(per 0.1ml)
Log 4
Log 5
Log 6
Log 7
Population
(per 0.1ml)
Log 4
Log 5
Log 6
Log 7
Population
(per 0.1ml)
Log 4
Log 5
Log 6
Log 7
Population
(per 0.1ml)
Log 4
Log 5
Log 6
Log 7
Population
(per 0.1ml)
Log 6
Log 7
Log 8
Log 9
Population
(per 0.1ml)
Log 4
Log 5
Log 6
Log 7
Log 8
Log 9
Population
(per 0.1ml)
Log 6
Log 7
Log 8
Log 9
Population
(per 0.1ml)
Log 6
Log 7
Log 8
Log 9
Population
(per 0.1ml)
Log 6
Smart-Read EZTest
Automatic documentation
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
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
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
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.
MesaLabs
Tel: +1-303-987-8000
www.MesaLabs.com
bisales@mesalabs.com