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SGM StripTM
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Spore Strip Biological Indicators
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SGM StripTM is a conventional Biological
Indicator for monitoring steam, ethylene oxide, dry heat, and radiation industrial
sterilization processes. It contains bacterial spores on a paper carrier sealed
within a convenient peel-open glassine envelope. After the sterilization process,
The BI is aseptically placed in soybean casein digest medium, and incubated at the
appropriate temperature for 7 days.
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Code
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Process
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Spore Species
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Incubation Time
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Incubation Temp.
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SGMS/6 (10E6)
SGMS/5 (10E5)
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Steam
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B. stearothermophilus
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7 Days
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55-600 C
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SGMS/6 (10E6)
SGMS/5 (10E5)
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EO Gas & Dry Heat
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B. subtilis
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7 Days
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30-350 C
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SGMD
SGMD
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Steam
EO Gas & Dry heat
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B. stearothermophilus
B. subtilis
(Dual species)
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7 Days
7 Days
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55-600 C
30-350 C
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SGMR
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Radiation
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B. pumilus
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7 Days
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30-350 C
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DriAmp® Culturing Set with Releasat
Medium
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DriAmp® biological indicator (BI) is ideal
to be used for high temperature applications where normal strip indicators cannot
be used. They can be used for dry heat tunnels or ovens which are used for Dry Heat
Sterilization and the materials of this indicator are all compatible to high temperature
conditions. It comes with a Releasat culture medium which has been formulated in
a way to produce results in just 72 hours.
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Code
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Process
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Spore Species
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Incubation Time
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Incubation Temp.
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DHR
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Dry Heat
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B. atrophaeus
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72 hours
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36-380 C
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EZTestTM
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Self-Contained Biological Indicators
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EZTest® is a self-contained Biological Indicator
for monitoring steam or ethylene oxide sterilization. EZTest contains bacterial
spores on a paper carrier packaged within a small, thermoplastic culture tube. Inside
the thermoplastic culture tube is a sealed glass amploue of specially formulated
soybean casein digest culture medium containing a color indicator that turns a dramatic
yellow when spores grow. EZTest is easy-to-use and produces visual results within
48 hours without laboratory transfers.
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Code
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Process
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Spore Species
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Incubation Time
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Incubation Temp.
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EZS/6 (10E6)
EZS/5 (10E5)
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Steam
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B. stearothermophilus
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48 Hours
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55-600 C
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EZG/6
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EO Gas
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B. subtilis
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48 Hours
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35-390 C
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MagnaAmpTM
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Solution Sterilization Biological Indicators
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MagnaAmpTM is a self-contained Biological Indicator ampoule for monitoring
steam sterilization of liquids in ampoules, large containers or washer sterilizers.
A small 1 mL snap-top constricted neck glass ampoule contains spores of Bacillus
stearothermophilus suspended in a specially formulated culture medium that turns
a dramatic yellow when the spores grow. The ampoule is so designed to sink to the
bottom of large containers for the most effective validation of the sterilization
cycle. MagnaAmp provides easy visual confirmation of sterilization within 48 hours
without the need of difficult and time-consuming laboratory work.
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Code
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Process
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Spore Species
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Incubation Time
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Incubation Temp.
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MA/6 (10E6)
MA/5 (10E5)
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Steam
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B. stearothermophilus
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48 hours
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55-600 C
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SterilAmp® II
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Solution Sterilization Biological Indicators
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SterilAmp II is a compact,
self-contained Biological Indicator in a small sealed glass tube for monitoring
industrial steam sterilization of liquids and precisely responds to the process
F0.
A low temperature Biological Indicator, B. subtilus 5230 is also available.
Both turn a dramatic yellow when spores grow.
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Code
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Process
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Spore Species
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Incubation Time
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Incubation Temp.
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SA/6 (10E6)
SA/5 (10E5)
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Steam
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B. stearothermophilus
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48 hours
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55-600 C
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SASU/6 (10E6)
SASU/5 (10E5)
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Steam
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B. subtilis "5230"
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48 Hours
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35-390 C
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SANC/6
SANC/5
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Negative Control
(Free-1 for every 10 SA or SASU)
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Steriflex Biological IndicatorTM
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Glass free version of Steri Amp (SA). It is in a convenient
to use pouch which can be used for liquid loads either for monitoring or for validation
of steam sterilizers. It can also be used to simulate liquid products like Injectable
and carry out D value Studies for the same.
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SPORE SUSPENSIONS
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Bacillus stearothermophilus, Bacillus subtilis, Bacillus
pumilus
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SGM Spore suspension is a calibrated suspension of bacterial
spores appropriate for preparing custom biological indicators for monitoring steam,
ethylene oxide, dry heat and radtation industrial sterilization processes.
Each vial contains 10 ml of a known concentration of spores suspended in 40% ethanol
or aqueous solution. The concentrations are specified per 0.1 ml.
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Code
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Process
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Spore Species
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Incubation Time
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Incubation Temp.
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SSS
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Steam
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B. stearothermophilus
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7 Days
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55-600 C
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SSG
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EO Gas & Dry Heat
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B. subtilis var.niger
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7 Days
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30-350 C
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SSR
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Radiation
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B. pumilus
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7 Days
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30-350 C
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SIP Biological Indicators and Accessories
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SGM Biotech along with Rubber Fab Technologies Group has
developed biological Indicator Gasket system to enable the use of Biological Idicators
in sanitary process lines. Indicators Like our EZ Test and SGM Strip can be used
along with these gaskets in SIP application. This unique Rubber Fab Smart Gasket®
permits either top loading or inline positioning of EZTest biological indicators
and/or temperature probes.
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SGMDiscTM for Hydrogen Peroxide
Vapor Biological Indicators
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It is used for Hydrogen peroxide sterilization and the
bacterial spores are present on a stainless steel disc. This is packaged in a peel
open Tyvek® /Mylar® envelope.
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Code
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Process
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Spore Species
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Incubation Time
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Incubation Temp.
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HPVD/6
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Hydrogen Peroxide
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G. stearothermophilus
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7 Days
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55-600 C
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EZTest® Biological Test Packs
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With Self-Contained Biological Indicators
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EZTest® Biological Test Packs
are available for both steam and EO gas processes. They are small and easy to use.
The steam test pack is approximately the size of deck of playing cards. Both test
packs parallel the performance of AAMI test packs and meet EN866-7. An EZTest®
Biological Indicator and a record card with a Chemical Indicator are enclosed
in each test pack.
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Code
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Process
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Spore Species
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Incubation Time
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Incubation Temp.
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STP/05
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Steam
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Bacillus stearothermophilus
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48 hours
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55-600 C
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ETP/05
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EO Gas
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Bacillus subtilis var niger
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48 Hours
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35-390 C
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Customized Biological Indicators
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SGM Biotech also offers Custom Biological Indicators designed to suit the specific
needs of a customer.
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SGM Biotech can work with the customer to create a suitable
biological indicator as per the customer’s requirements. All the various types of
carriers as well as the shape of Process challenge device can be designed suiting
to customer requirements.
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Lethality MapperTM
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It is a Microsoft Excel based Add In software which is
designed by SGM Biotech, Inc. for determination of cold spots in a sterilizer. It
is a very useful tool in mapping a sterilizer for validation purpose.
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Availability
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Lethality Mapper v1.0
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CDROM (1)
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LETHMAP
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