Biological Indicators
Biological indicators (BIs) contain viable microorganisms that provide a defined resistance to a specified sterilization process.
Trusted by pharmaceutical and medical device manufacturers, food and beverage manufacturers, hospitals, ambulatory surgical centers, dentists and more, BIs enable validation and verification of disinfection and sterilization cycles.
Table of Contents
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Steam Sterilization .................................................. 4 Solid Loads ........................................................................................................ 4 EZTest® SCBI 4 EZTest Test Pack 4 Smart-Read® EZTest SCBI 5 Smart-Read EZTest Test Pack 5 MesaStrip ..................................................................................................... 6 Spore Strips................................................................................................... 6 UniQ® MicroStrip and Disc 8 UniQ ProLine 8 Liquid Loads 9 ProSpore® 9 MagnaAmp®................................................................................................10 SterilAmp® ...................................................................................................10 UniQ Spore Suspension 11 Low-Temperature Steam Sterilization .................... 12 Solid Loads 12 MesaStrip 12 UniQ MicroStrip .........................................................................................13 Liquid Loads 14 SterilAmp 14 UniQ Spore Suspension 15 Ethylene Oxide Sterilization ................................... 16 EZTest SCBI .....................................................................................................16 MesaStrip 17 Releasat® Culturing Set 17 Spore Strips 18 UniQ MicroStrip, Disc, Thread 19 UniQ Spore Suspensions 20 Process Challenge Device (PCD®) ............................................................... 20 Dry Heat Sterilization ............................................ 24 MesaStrip 24 Releasat Culturing Set 25 Spore Strips 26 UniQ DriAmp Culturing Set ........................................................................... 27 UniQ Spore Suspension ................................................................................. 27 Vaporized Hydrogen Peroxide Decontamination .... 28 Apex® EZTest SCBI ........................................................................................28 Apex Packaged Discs 29 Apex Bare Ribbon 30 Releasat Purple Culture Media 30 UniQ Spore Suspension 31 Hydrogen Peroxide Sterilization ............................ 32 ExpoSure® SCBI 32 EZTest SCBI 33 Process Challenge Device (PCD) 33 Gamma Irradiation Sterilization ............................. 34 MesaStrip .........................................................................................................34 UniQ Disc ..........................................................................................................34 UniQ Spore Suspension 35 Chlorine Dioxide Sterilization ................................ 36 Ozone Sterilization ................................................ 37 Mesa UniQ Spore Suspensions .............................. 38 Sterilization & Decontamination 38 Growth Promotion 40 Accessories .......................................................... 41 Incubators ........................................................................................................41 Smart-Read Monitoring System .................................................................. 41 Population Assay Materials 41 Chemical Indicators .............................................. 42 United States 42 Outside of the United States 43 Contract Laboratory Testing and Services ............. 44 Biological Indicator Label Claim Verification 45 Cycle Development and Validation Services 45 Custom Solutions 45
STEAM STERILIZATION
Steam is one of the most common sterilization methods due to its nontoxic, inexpensive, and rapid sporicidal process properties. Sterilization is achieved by exposing products to saturated steam at high temperatures (121°C to 135°C). Steam is used to sterilize both solid loads (parts, hard goods, or porous items) and liquid loads. The load type will dictate the type of biological indicators used.
Solid Loads
Solid items are sterilized by direct contact with the steam generated by the autoclave. The biological indicator used for these types of loads must allow for the spores on the carrier material to be directly contacted by the steam.
EZTest
EZTest is a self-contained BI that contains bacterial spores on a paper carrier, packaged within a small, thermoplastic culture tube along with a sealed-glass media ampoule. The specially formulated soybean casein digest culture medium contains the pH indicator Bromocresol Purple, which changes to yellow during incubation if any spores have survived the process. EZTest Steam has been validated for a 24-hour reduced incubation time and is cleared for use in U.S. healthcare.
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Item Part Number Species Population Packaging EZTest Steam EZS/6 G. stearothermophilus 7953 106 100/box EZTest Steam EZS/625 G. stearothermophilus 7953 106 25/box EZTest Steam EZS/5 G. stearothermophilus 7953 105 100/box
Smart-Read EZTest
The Smart-Read EZTest Biological Monitoring System* allows an organization to release sterile product with true biological confirmation. This unique system uses a BI – with no added enzyme – 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. Smart-Read EZTest is cleared for use in U.S. healthcare.
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Item Part Number Species Population Packaging EZTest Steam EZS/525 G. stearothermophilus 7953 105 25/box EZTest Test Pack STP/25 G. stearothermophilus 7953 105 25 test packs with 25 controls/case Item Part Number Species Population Packaging Smart-Read EZTest SEZS/6 G. stearothermophilus 7953 106 100/box Smart-Read EZTest EZS/625 G. stearothermophilus 7953 106 25/box Smart-Read EZTest SEZS/5 G. stearothermophilus 7953 105 100/box Smart-Read EZTest SEZS/525 G. stearothermophilus 7953 105 25/box Smart-Read EZTest Test Pack SRSP6/25 G. stearothermophilus 7953 106 25 test packs with 25 controls/case Smart-Read EZTest Test Pack SRSP/25 G. stearothermophilus 7953 105 25 test packs with 25 controls/case
Smart-Well
Kits
the Accessories section
*See the
Incubator
in
*See the EZTest Incubator in the Accessories Section in small font at the bottom of the table.
MesaStrip
MesaStrip contains bacterial spores on a paper carrier sealed within a convenient, peel-open glassine envelope.
Dimensions: Strip 6x25mm, glassine envelope 25x76mm
Releasat Purple Culture Media is a specially formulated soybean casein digest culture medium containing the pH indicator Bromocresol Purple which changes to yellow during incubation if any spores have survived the process. Each 16 x 100 mm tube contains 3.6 mL of medium.
Spore Strips
Spore Strips are inoculated with bacterial spores on a paper carrier sealed within a convenient, peel-open glassine envelope. Spore Strips are cleared for use in U.S. healthcare.
Dimensions: Strip 6x38mm, glassine envelope 25x76mm
Modified Tryptic Soy Broth with Bromocresol Purple (TSB-BP16) culture media for Spore Strips is a specially formulated soybean casein digest
6 Item Part Number Species Population Packaging MesaStrip Steam SGMS/6 G. stearothermophilus 7953 106 100/bag MesaStrip Steam SGMS/5 G. stearothermophilus 7953 105 100/bag MesaStrip Steam SGMS/3 G. stearothermophilus 7953 103 100/bag Releasat Purple Culture Media PM/100 N/A N/A 100/box
STEAM STERILIZATION
culture medium containing the pH indicator Bromocresol Purple which changes to yellow during incubation if any spores have survived the process. Each 16 x 100 mm tube contains 6.5 mL of medium.
A reduced incubation time of 24 hours at 60°C +/- 2°C has been validated for steam sterilization when Spore Strips (either single species or the dual-species) are used in conjunction with Mesa’s TSB-BP16 culture media. When using culture media other than TSB-BP16, incubate at 55 - 60°C for 7 days.
7 Item Part Number Species Population Packaging Spore Strips Single Species 3-6100 G. stearothermophilus 7953 106 100/bag Spore Strips Single Species 3-1000 G. stearothermophilus 7953 106 1000/bag Spore Strips Single Species 3-5100 G. stearothermophilus 7953 105 100/bag Spore Strips Single Species 3-4100 G. stearothermophilus 7953 104 100/bag Spore Strips Combined Species 5-5100 B. atrophaeus 9372 & G. stearothermophilus 7953 106 & 105 100/bag Spore Strips Combined Species (test strips) 5-1000T B. atrophaeus 9372 & G. stearothermophilus 7953 106 & 105 1000/bag Spore Strips Combined Species (control strips) 5-1000C B. atrophaeus 9372 & G. stearothermophilus 7953 106 & 105 1000/bag Modified TSB with BCP Culture Media TSB-BP16 N/A N/A 100/box
UniQ Biological Indicators
Manufacturers and validation specialists may require a UniQ solution when standard spore strips or SCBIs are not suitable because of size, packaging, or carrier material. Mesa offers a line of Mesa UniQ BIs to address the specific requirements of the medical device, pharmaceutical, and food & beverage industries.
UniQ ProLine
UniQ ProLine is a device that contains an inoculated paper disc packaged in a glassine envelope which is located in the center of the ProLine housing. This biological indicator system is designed for use in the validation or routine monitoring of steam sterilization cycles of tubing ranging from
8 Item Size Part Number Species Population Packaging UniQ MicroStrip 1 x 25 mm S1X25/6 G. stearothermophilus 7953 106 100/bag UniQ MicroStrip 1 x 25 mm S1X25/6G* G. stearothermophilus 7953 106 100/bag UniQ MicroStrip 2 x 10 mm S2X10/6 G. stearothermophilus 7953 106 100/bag UniQ MicroStrip 2 x 10 mm S2X10/6G* G. stearothermophilus 7953 106 100/bag UniQ Disc 6 mm DS6R/6 G. stearothermophilus 7953 106 100/bag UniQ Disc 6 mm DS6R/6G* G. stearothermophilus 7953 106 100/bag
STEAM STERILIZATION
* Individually packaged in glassine envelopes
1/8” to 5/8” inner diameter. It allows the user to place the BI at the center of the length of the tubing which is the most difficult place for the sterilant to penetrate.
Liquid Loads
The sterilization of liquids is very different from the sterilization of solid loads. Liquids are not sterilized by direct contact with the steam in the autoclave chamber. Sterilization of liquids is achieved by heating the container which then heats the liquid in the container. The biological indicator must be placed inside the container so that it monitors the conditions in the container making a sealed glass ampoule the ideal choice.
ProSpore
The neck of the ProSpore ampoule makes it easy to suspend in the slowest-to-heat geometric center of volumes of liquid over 150 mL. The ampoule can also be used as a surrogate by placing it amongst vials of product of the same size. ProSpore has been validated for a 48-hour reduced incubation time and is cleared for use in U.S. healthcare at 121°C.
*See the ProSpore Incubator in the Accessories section
9 Item Size Part Number Species Population Packaging ProSpore 4 mL PS-6-50 G. stearothermophilus 7953 106 50/box ProSpore 4 mL PS-5-50 G. stearothermophilus 7953 105 50/box ProSpore 4 mL PS-4-50 G. stearothermophilus 7953 104 50/box Item Part Number Species Population Packaging UniQ ProLine PL-3-6-15 G. stearothermophilus 7953 106 15/box
STEAM STERILIZATION
MagnaAmp
The neck of the MagnaAmp ampoule makes it easy to suspend in the slowest-to-heat geometric center of volumes of liquid over 150 mL. The ampoule can also be used as a surrogate by placing it amongst vials of product of the same size. Negative controls which serve as a color comparison for media that is discolored by high temperatures or long cycles are included. MagnaAmp has been validated for a 48-hour reduced incubation time.
Looking for a custom solution? See page 45 for our custom services and capabilities.
*See the MagnaAmp Incubator in the Accessories section
SterilAmp
SterilAmp’s small size makes it ideal for sterilizing volumes of liquid less than 150 mL and the SterilAmp 18 mm is small enough to fit into blister packs. Negative controls which serve as a color comparison for media that is discolored by high temperatures or long cycles are included. SterilAmp has been validated for a 48-hour reduced incubation time.
10 Item Size Part Number Species Population Packaging MagnaAmp 1 mL MA/6 G. stearothermophilus 7953 106 50 + 10 NC/ box MagnaAmp 1 mL MA/5 G. stearothermophilus 7953 105 50 + 10 NC/ box MagnaAmp 1 mL MA/4 G. stearothermophilus 7953 104 50 + 10 NC/ box MagnaAmp Negative Controls 1 mL MANC G. stearothermophilus 7953 N/A 10/box
UniQ Spore Suspension
Spore Suspensions are calibrated suspensions of bacterial spores appropriate for direct inoculation of products or customers’ choice of substrate (solid or liquid) for monitoring steam sterilization processes.
11 Item Size Part Number Species Population Packaging SterilAmp 6.75 x 26.5 mm SA/6 G. stearothermophilus 7953 106 100 + 10 NC/bag SterilAmp 6.75 x 26.5 mm SA/5 G. stearothermophilus 7953 105 100 + 10 NC/bag SterilAmp 6.75 x 26.5 mm SA/4 G. stearothermophilus 7953 104 100 + 10 NC/bag SterilAmp Negative Controls 6.75 x 26.5 mm SANC G. stearothermophilus 7953 N/A 10/bag SterilAmp 18mm 6.75 x 18 mm SA18/6 G. stearothermophilus 7953 106 100 + 10 NC/bag SterilAmp 18mm 6.75 x 18 mm SA18/ NC50 G. stearothermophilus 7953 106 100 + 50 NC/bag SterilAmp 18mm 6.75 x 18 mm SANC18 G. stearothermophilus 7953 N/A 10/bag Item Part Number Population Diluent Packaging G. stearothermophilus 7953 SSSE/4 104/0.1 mL 40% ethanol 10 mL vial SSSE/5 105/0.1 mL SSSE/6 106/0.1 mL SSSE/7 107/0.1 mL SSSA/7 107/0.1 mL Sterile Water B. smithii 51232 SSSME/7 107/0.1 mL 20% ethanol
LOW-TEMPERATURE STEAM STERILIZATION
If a product’s stability will be compromised by exposure to hightemperature (121 - 135°C) steam sterilization, it may be necessary to utilize lower temperatures (110 - 118°C) and thus a biological indicator with a less resistant organism.
Solid Loads
Solid items are sterilized by direct contact with the steam generated by the autoclave. The biological indicator used for these types of loads must allow for the spores on the carrier material to be directly contacted by the steam.
MesaStrip
MesaStrip contains bacterial spores on a paper carrier sealed within a convenient, peel-open glassine envelope.
Dimensions: Strip 6x25mm, glassine envelope 25x76mm
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Item Part Number Species Population Packaging MesaStrip Low Temperature Steam SGMSU/6 B. subtilis ‘5230’ 35021 106 100/bag
UniQ Biological Indicators
Manufacturers and validation specialists may require a UniQ solution when standard spore strips or SCBIs are not suitable because of size, packaging, or carrier material. Mesa offers a line of Mesa UniQ BIs to address the specific requirements of the medical device, pharmaceutical, and food & beverage industries.
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Item Size Part Number Species Population Packaging UniQ MicroStrips 1 x 25 mm SU1X25/6 B. subtilis ‘5230’ 35021 106 100/bag UniQ MicroStrips 2 x 10 mm SU2X10/6 B. subtilis ‘5230’ 35021 106 100/bag
LOW-TEMPERATURE STEAM STERILIZATION
Liquid Loads
The sterilization of liquids is very different from the sterilization of solid loads. Liquids are not sterilized by direct contact with the steam in the autoclave chamber. Sterilization of liquids is achieved by heating the container which then heats the liquid in the container. The biological indicator must be placed inside the container so that it monitors the conditions in the container making a sealed glass ampoule the ideal choice.
SterilAmp 5230
SterilAmp’s small size makes it ideal for placing in even the smallest of containers. Negative controls which serve as a color comparison for media that is discolored by thermal insult are included.
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Item Size Part Number Species Population Packaging SterilAmp 5230 6.75 x 26.5 mm SASU/6 B. subtilis ‘5230’ 35021 106 100 + 10 NC/bag SterilAmp 5230 Negative Controls 6.75 x 26.5 mm SASUNC N/A N/A 10/bag
UniQ Spore Suspension
Spore Suspensions are calibrated suspensions of bacterial spores appropriate for direct inoculation of products or customers’ choice of substrate (solid or liquid) for monitoring steam sterilization processes.
SS5230E/7
SS5230A/7
15 Item Part Number Population Diluent Packaging B. subtilis ‘5230’ 35021
104/0.1 mL 40% ethanol 10 mL vial
105/0.1 mL
106/0.1 mL
SS5230E/4
SS5230E/5
SS5230E/6
107/0.1 mL
108/0.1 mL
SS5230E/8
107/0.1 mL Sterile Water
sporogenes 7955
104/0.1 mL 40% ethanol
105/0.1 mL
C.
SSCS7955/4
SSCS7955/5
6/0.1 mL
SSCS7955/6 10
7/0.1 mL
SSCS7955/7 10
ETHYLENE OXIDE (EO) STERILIZATION
EO sterilization is one of the most common sterilization methods for medical device manufacturing, including specialty device kits used for surgical procedures. The chemical process consists of four primary variables: gas concentration, humidity, temperature, and time. EO is an alkylating agent that disrupts the DNA of microorganisms, which prevents them from reproducing.
EZTest
EZTest is a self-contained BI that contains bacterial spores on a paper carrier, packaged within a small, thermoplastic culture tube along with a sealed-glass media ampoule. The specially formulated soybean casein digest culture medium contains the pH indicator Phenol Red, which changes to yellow during incubation if any spores have survived the process. EZTest EO has been validated for a 48-hour reduced incubation time and is cleared for use in U.S. healthcare.
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Item Part Number Species Population Packaging EZTest Gas EZG/6 B. atrophaeus 9372 106 100/box EZTest Gas EZG/625 B. atrophaeus 9372 106 25/box
Consistent and proper use of BIs helps ensure product safety. Mesa can augment or fully support your sterility program.
MesaStrip
MesaStrip contains bacterial spores on a paper carrier sealed within a convenient, peel-open glassine envelope.
Dimensions: Strip 6x25mm, glassine envelope 25x76mm
Releasat Red Culture Media is a specially formulated soybean casein digest culture medium containing the pH indicator Phenol Red which changes to yellow during incubation if any spores have survived the process. Each 16 x 100 mm tube contains 3.6 mL of medium.
Releasat Culturing Set
The Releasat Culturing Set contains both MesaStrip EO/Dry Heat and Releasat Culture Media which as a set have been validated for a 72-hour reduced incubation time.
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Item Part Number Species Population Packaging MesaStrip EO/Dry Heat SGMG/6 B. atrophaeus 9372 106 100/bag Releasat Red Culture Media RM/100 N/A N/A 100/box Item Part Number Species Population Packaging Releasat Culturing Set RG/100 B. atrophaeus 9372 106 100 MesaStrips & 100 Releasat media tubes/box
ETHYLENE OXIDE (EO) STERILIZATION
Spore Strips
Spore Strips are inoculated with bacterial spores on a paper carrier sealed within a convenient, peel-open glassine envelope. Spore Strips are cleared for use in U.S. healthcare.
Dimensions: Strip 6x38mm, glassine envelope 25x76mm
Modified Tryptic Soy Broth with Bromocresol Purple (TSB-BP16) culture media for Spore Strips is a specially formulated soybean casein digest culture medium containing the pH indicator Bromocresol Purple which changes to yellow during incubation if any spores have survived the process. Each 16 x 100 mm tube contains 6.5 mL of medium.
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Item Part Number Species Population Packaging Spore Strips Single Species 1-6100 B. atrophaeus 9372 106 100/bag Spore Strips Single Species 1-1000 B. atrophaeus 9372 106 1000/bag Spore Strips Single Species 1-4100 B. atrophaeus 9372 104 100/bag Spore Strips Combined Species 5-5100 B. atrophaeus 9372 & G. stearothermophilus 7953 106 & 105 100/bag Spore Strips Combined Species (test strips) 5-1000T B. atrophaeus 9372 & G. stearothermophilus 7953 106 & 105 1000/bag Spore Strips Combined Species (control strips) 5-1000C B. atrophaeus 9372 & G. stearothermophilus 7953 106 & 105 1000/bag Modified TSB with BCP Culture Media TSB-BP16 N/A N/A 100/box
UniQ Biological Indicators
Manufacturers and validation specialists may require a UniQ solution when standard spore strips or SCBIs are not suitable because of size, packaging, or carrier material. Mesa offers a line of Mesa UniQ BIs to address the specific requirements of the medical device, pharmaceutical, and food & beverage industries.
*Individually packaged in glassine envelopes
**Individually packaged in Tyvek®/Mylar® envelopes
19 Item Size Part Number Species Population Packaging UniQ MicroStrip 1 x 25 mm A1X25/6 B. atrophaeus 9372 106 100/bag UniQ MicroStrip 1 x 25 mm A1X25/6G* B. atrophaeus 9372 106 100/bag UniQ MicroStrip 2 x 10 mm A2X10/6 B. atrophaeus 9372 106 100/bag UniQ MicroStrip 2 x 10 mm A2X10/6G* B. atrophaeus 9372 106 100/bag UniQ Disc 6 mm 1-61006MM B. atrophaeus 9372 106 100/bag UniQ Disc 6 mm 10006MM B. atrophaeus 9372 106 1000/bag UniQ Thread 1.5 x 19 mm 1-6100TT** B. atrophaeus 9372 106 100/bag
ETHYLENE OXIDE (EO) STERILIZATION
UniQ Spore Suspension
Spore Suspensions are calibrated suspensions of bacterial spores appropriate for direct inoculation of products or customers’ choice of substrate for monitoring EO sterilization processes.
Process Challenge Device (PCD)
Mesa PCD products consist of commercial spore strips, discs or self-contained BIs in a proprietary EO barrier pouch. For greater efficiency, PCDs packaged with self-contained biological indicators, enable you to see the results, without waiting for a 7-day incubation period or sending the indicator to the lab for results.
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Item Part Number Population Diluent Packaging B. atrophaeus 9372 SSGE/4 104/0.1 mL 40% ethanol 10 mL vial SSGE/5 105/0.1 mL SSGE/6 106/0.1 mL SSGE/7 107/0.1 mL SSGE/8 108/0.1 mL
PCD Selection Set
PCD Selection Set consists of an EZTest EO SCBI packaged in four different pouch configurations which each provide a different resistance to ethylene oxide sterilization. The PCD Selection Set eliminates the need to purchase multiple PCD types and allows for easy side-by-side comparison during validation in order to select the appropriate PCD type for routine cycles.
To learn more about Mesa
PCDs, download the PCD Selection Guide
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Item Part Number Pouch Type Nominal D-Value Packaging EZTest SCBI PCDV.13 Type 7 26 25/set Type 6 35 25/set Type 4 50 25/set Type 2 58 25/set
ETHYLENE OXIDE (EO) STERILIZATION
Standard PCDs
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Item Part Number BI Manufacturer Nominal D-Value Packaging Type 3 - Least Resistance EZTest Self-Contained BI PCD 3.13 MESA 3 100 Spore Strip without Glassine PCD 3.2 Steris 3 100 Spore Strip in Glassine PCD 3.5 MESA 4 100 Attest™ Self-Contained BI PCD 3.6 3M 5 100 Attest Rapid Readout BI PCD 3.9 3M 5 100 Type 5 - Low Resistance UniQ Disc PCD 5.1 MESA 4 100 EZTest Self-Contained BI PCD 5.13 MESA 13 100 Spore Strip without Glassine PCD 5.2 Steris 4 100 Spore Strip in Glassine PCD 5.5 MESA 5 100 Attest Self-Contained BI PCD 5.62 3M 13 100 Attest Rapid Readout BI PCD 5.92 3M 13 100 Type 4 - Medium Resistance UniQ Disc PCD 4.1 MESA 21 100 EZTest Self-Contained BI PCD 4.13 MESA 50 100 Spore Strip without Glassine PCD 4.2 Steris 21 100 Spore Strip in Glassine PCD 4.5 MESA 32 100 Attest Self-Contained BI PCD 4.6 3M 50 100 Spore Strip in Glassine PCD 4.7 Steris 32 100 Attest Rapid Readout BI PCD 4.9 3M 50 100
23 Item Part Number BI Manufacturer Nominal D-Value Packaging Type 6 - Medium Resistance UniQ Disc PCD 6.1 MESA 12 100 EZTest Self-Contained BI PCD 6.13 MESA 35 100 Spore Strip without Glassine PCD 6.2 Steris 12 100 Spore Strip in Glassine PCD 6.5 MESA 17 100 Attest Self-Contained BI PCD 6.6 3M 35 100 Spore Strip in Glassine PCD 6.7 Steris 17 100 Attest Rapid Readout BI PCD 6.9 3M 35 100 Type 7 - Medium Resistance UniQ Disc PCD 7.1 MESA 9 100 EZTest Self-Contained BI PCD 7.13 MESA 26 100 Spore Strip without Glassine PCD 7.2 Steris 9 100 Spore Strip in Glassine PCD 7.5 MESA 14 100 Attest Self-Contained BI PCD 7.6 3M 26 100 Spore Strip in Glassine PCD 7.7 Steris 14 100 Attest Rapid Readout BI PCD 7.9 3M 26 Type 2 - Most Resistance UniQ Disc PCD 2.1 MESA 28 100 Spore Strip without Glassine PCD 2.12 MESA 28 100 EZTest Self-Contained BI PCD 2.13 MESA 58 100 Spore Strip without Glassine PCD 2.2 Steris 28 100 Spore Strip in Glassine PCD 2.5 MESA 37 100 Attest Self-Contained BI PCD 2.6 3M 58 100 Spore Strip in Glassine PCD 2.7 Steris 37 100 Attest Rapid Readout BI PCD 2.9 3M 58 100
DRY HEAT STERILIZATION
One of the earliest forms of sterilization practiced, dry heat sterilization is accomplished by conduction, where heat is absorbed by the exterior surface and passed inward to the next layer. Dry heat sterilization is ideal for heat-stable items such as glass, stainless steel, non-aqueous liquids, powders, etc. The essential cell components are destroyed, and the organism is killed by oxidizing molecules.
MesaStrip
MesaStrip contains bacterial spores on a paper carrier sealed within a convenient, peel-open glassine envelope.
Dimensions: Strip 6x25mm, glassine envelope 25x76mm
Releasat Red Culture Media is a specially formulated soybean casein digest culture medium containing the pH indicator Phenol Red which changes to yellow during incubation if any spores have survived the process. Each 16 x 100 mm tube contains 3.6 mL of medium.
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Item Part Number Species Population Packaging MesaStrip EO/ Dry Heat SGMG/6 B. atrophaeus 9372 106 100/bag Releasat Red Culture Media RM/100 N/A N/A 100/box
Releasat Culturing Set
The Releasat Culturing Set contains both MesaStrip EO/Dry Heat and Releasat Red Culture Media which as a set have been validated for a 72-hour reduced incubation time.
Custom BIs are also available. Contact us for more information.
25 Item Part Number Species Population Packaging Releasat Culturing Set RG/100 B. atrophaeus 9372 106 100 MesaStrips & 100 Releasat media tubes/box
DRY HEAT STERILIZATION
Spore Strips
Spore Strips are inoculated with bacterial spores on a paper carrier sealed within a convenient, peel-open glassine envelope. Spore Strips are cleared for use in U.S. healthcare.
Dimensions: Strip 6x38mm, glassine envelope 25x76mm
Modified Tryptic Soy Broth with Bromocresol Purple (TSB-BP16) culture media for Spore Strips is a specially formulated soybean casein digest culture medium containing the pH indicator Bromocresol Purple which changes to yellow during incubation if any spores have survived the process. Each 16 x 100 mm tube contains 6.5 mL of medium.
26 Item Part Number Species Population Packaging Spore Strips Single Species 1-6100 B. atrophaeus 9372 106 100/bag Spore Strips Single Species 1-1000 B. atrophaeus 9372 106 1000/bag Spore Strips Single Species 1-4100 B. atrophaeus 9372 104 100/bag Spore Strips Combined Species 5-5100 B. atrophaeus 9372 & G. stearothermophilus 7953 106 & 105 100/bag Spore Strips Combined Species (test strips) 5-1000T B. atrophaeus 9372 & G. stearothermophilus 7953 106 & 105 1000/bag Spore Strips Combined Species (control strips) 5-1000C B. atrophaeus 9372 & G. stearothermophilus 7953 106 & 105 1000/bag Modified TSB with BCP Culture Media TSB-PB16 N/A N/A 100/box
UniQ DriAmp Culturing Set
UniQ DriAmp Culturing Set includes DriAmp glass ampoules containing inoculated silica and tubes of Releasat Red Culture Media which together have been validated for a 72-hour reduced incubation time. DriAmp biological indicator is designed for use in high-temperature (>180°C) dry heat cycles where paper strips in glassine can be damaged. DriAmp can withstand depyrogenation cycles and is ideal for submersion in oils or other non-aqueous solutions.
UniQ Spore Suspension
Spore Suspensions are calibrated suspensions of bacterial spores appropriate for direct inoculation of products or customers’ choice of substrate used for monitoring dry heat and sterilization processes.
27 Item Part Number Species Population Packaging UniQ DriAmp Culturing Set DH/50 B. atrophaeus 9372 106 50 DriAmp & 50 Releasat Red media tubes/box Item Part Number Population Diluent Packaging B. atrophaeus 9372 SSGE/4 104/0.1 mL 40% ethanol 10 mL vial SSGE/5 105/0.1 mL SSGE/6 106/0.1 mL SSGE/7 107/0.1 mL SSGE/8 108/0.1 mL
VAPORIZED HYDROGEN PEROXIDE (VH 2 O 2) DECONTAMINATION
Vaporized Hydrogen Peroxide is widely used to decontaminate aseptic filling lines, isolators, restricted access barrier systems and other enclosures used for the manufacture of products that are not suitable for terminal sterilization.
Apex biological indicators are intended for the biopharmaceutical, medical device, and food industries utilizing VH2O2 decontamination. The stainless-steel carrier is compatible with VH2O2, provides an ideal surface for proper spore presentation, and mimics the material of construction of aseptic fill equipment which makes them the perfect choice for aseptic filling processes.
Apex EZTest SCBI
Apex EZTest consists of a 9 mm x 0.2 mm stainless steel disc inoculated with Geobacillus stearothermophilus 12980 presented in a self-contained biological indicator (SCBI). The incorporated media ampoule not only eliminates the need for a clean bench to culture the BIs but also minimizes the chance of post-exposure contamination during culturing.
The Apex EZTest Crusher can be used as a holder for Apex EZTest SCBIs during exposure as well as a crusher for the media ampoules and capper for the units during culturing. This tool facilitates the placement and capping of 3 SCBIs at one time.
28 Item Part Number Species Population Packaging Apex EZTest AP-VH2O2SC-S12980/6 G. stearothermophilus 12980 106 30/bag Apex EZTest Crusher AP-CRUSH N/A N/A 1/box
Apex Discs
Apex Discs consist of a 9 mm diameter x 0.2 mm thick stainless steel disc inoculated with varying populations of either Geobacillus stearothermophilus 12980, Geobacillus stearothermophilus 7953 or Bacillus atrophaeus 9372. The discs are packaged in a medical-grade Tyvek® envelope which is permeable to VH2O2. The envelope has a small hole to facilitate hanging and a thumb notch for peeling. Apex Tri-scale Discs (LOG-456) conveniently provides 3 different populations in one packaging configuration to assist in cycle development and initial validations.
29 Item Part Number Species Population Packaging Discs HMV-091 G. stearothermophilus 12980 106 100/bag KCD-404 G. stearothermophilus 12980 104 100/bag HMV-091E3* G. stearothermophilus 12980 103 100/bag LOG-456 G. stearothermophilus 12980 104, 105, 106 100/bag NAS-152 G. stearothermophilus 7953 106 50/bag NAS-152E4* G. stearothermophilus 7953 104 100/bag NAS-152E3* G. stearothermophilus 7953 103 100/bag GRS-090 B. atrophaeus 9372 106 100/bag GRS090E5* B. atrophaeus 9372 105 100/bag GRS-090E3* B. atrophaeus 9372 103 100/bag
*Product is made to order
VAPORIZED HYDROGEN PEROXIDE (VH 2 O 2) DECONTAMINATION
Apex Ribbons
Apex Ribbons consist of a 6.4 mm x 70 mm stainless steel ribbon inoculated on one end with Geobacillus stearothermophilus 12980 and are thin and flexible for easy placement in tight locations. The ribbons are packaged in a Tyvek sleeve but are removed for exposure. The Sterile Tyvek Transfer Pocket (BMWK-750) facilitates the transportation of the exposed ribbons to the laboratory for culturing.
Culture Media for G. stearothermophilus
For use with BIs containing Geobacillus stearothermophilus, Releasat Purple Culture Media is a specially formulated soybean casein digest culture medium containing the pH indicator Bromocresol Purple which changes to yellow during incubation if any spores have survived the process. Each 16 x 100 mm tube contains 3.6 mL of medium.
30 Item Part Number Species Population Packaging Ribbon SBC-327 G. stearothermophilus 12980 106 100/bag Tyvek Transfer Pocket for SBC-327 BMWK-750 N/A N/A 100 sleeve pockets Item Part Number Species Population Packaging Releasat Purple Culture Media PM/100 N/A N/A 100/box
UniQ Spore Suspension
Spore Suspensions are calibrated suspensions of sterilization-resistant bacterial spores appropriate for direct inoculation of products or customers’ choice of substrate used for monitoring VH2O2 decontamination processes.
31 Item Part Number Population Diluent Packaging G. stearothermophilus 12980 LAU-196 106 29% ethanol 10 mL vial G. stearothermophilus 7953 LPT-606 106 40% ethanol 10 mL vial
HYDROGEN PEROXIDE STERILIZATION
H2O2 sterilization is a low-temperature process that provides gentle sterilization for delicate instruments in about an hour or less. Temperatures do not exceed 50°C, and sterilization occurs in a low moisture environment.
ExpoSure
ExpoSure is a self-contained BI consisting of bacterial spores on a quartz fiber disc, packaged within a small, thermoplastic culture tube with a sealed-glass ampoule of specially formulated soybean casein digest culture medium containing a pH indicator Bromocresol Purple which changes to yellow during incubation if any spores have survived the process. ExpoSure is intended for use in STERRAD® Sterilizers and is suitable for healthcare and non-healthcare settings. Its 24-hour reduced incubation time and flexibility make it a powerful tool to help your facility maintain compliance and patient safety.
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Item Part Number Species Population Packaging ExpoSure EXPO/6 G. stearothermophilus 7953 106 30/box + 1 crusher
EZTest
EZTest is a self-contained BI consisting of bacterial spores on a stainless-steel disc, packaged within a small, thermoplastic culture tube with a sealed-glass ampoule of specially formulated soybean casein digest culture medium containing the pH indicator Bromocresol Purple which turns yellow during incubation if any spores have survived the process. EZTest H2O2 has been validated for a 24-hour reduced incubation time.
Process Challenge Device (PCD)
Utilizing a proprietary H2O2 barrier pouch and EZTest H2O2, PCD provides a convenient and consistent challenge to the sterilization process that is greater than a biological indicator alone.
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Item Part Number Species Population Packaging EZTest H2O2 EZH/5 G. stearothermophilus 7953 105 100/box EZTest H2O2* EZH/5I G. stearothermophilus 7953 105 100/box EZTest H2O2 EZH/6 G. stearothermophilus 7953 106 100/box EZTest H2O2* EZH/6I G. stearothermophilus 7953 106 100/box *For outside of the United States Part Number BI Manufacturer BI Type Packaging PCD 8.13 Mesa SCBI to H2O2 100/box
GAMMA IRRADIATION STERILIZATION
Exposing products to a Cobalt 60 radiation field, gamma irradiation is known for its quick turnaround times, easy penetration of packaging, and is ideal for many types of materials.
MesaStrip
MesaStrip contains bacterial spores on a filter paper carrier sealed within a convenient, peel-open glassine envelope.
Dimensions: Strip 6x25mm, glassine envelope 25x76mm
UniQ Disc
UniQ stainless-steel Disc is frequently used for UV processes because the clear plastic packaging does not impede the UV light and provides protection from post-process contamination.
Dimensions: 7mm
*Product is made to order
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Item Part Number Species Population Packaging MesaStrip Radiation SGMR/6 B. pumilus 27142 106 100/bag MesaStrip Radiation SGMR/7 B. pumilus 27142 107 100/bag Item Part Number Species Population Packaging Mesa UniQ Disc DPSSC/3* B. pumilus 27142 103 100/bag Mesa UniQ Disc DPSS/6C B. pumilus 27142 106 100/bag
UniQ Spore Suspension
Spore Suspensions are calibrated suspensions of bacterial spores appropriate for direct inoculation of products or customers’ choice of substrate used for monitoring radiation sterilization processes.
35 Item Part Number Population Diluent Packaging B. pumilus 27142 SSRE/4 104/0.1 mL 40% ethanol 10 mL vial SSRE/5 105/0.1 mL SSRE/6 106/0.1 mL SSRE/7 107/0.1 mL SSRE/8
8/0.1 mL
10
CHLORINE DIOXIDE STERILIZATION
Chlorine dioxide is a true gas at room temperature which leads to excellent distribution and the small molecule size lends to the ability to penetrate into the smallest of areas. Chlorine dioxide is compatible with wide variety of materials and leaves no residuals making it ideal for the decontamination of facilities or the sterilization of medical devices.
MesaStrip
MesaStrip contains bacterial spores on a paper carrier sealed within a convenient, peel-open Tyvek/Mylar® envelope.
Dimensions: Strip 6x19mm, Tyvek/Mylar envelope 45x76mm
Releasat Red Culture Media is a specially formulated soybean casein digest culture medium containing the pH indicator Phenol Red which changes to yellow during incubation if any spores have survived the process. Each 16 x 100 mm tube contains 3.6 mL of medium.
*Product is made to order
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Item Part Number Species Population Packaging MesaStrip Chlorine Dioxide ACD/6 B. atrophaeus 9372 106 100/bag MesaStrip Chlorine Dioxide ACD/3* B. atrophaeus 9372 103 100/bag Releasat Red Culture Media RM/100 N/A N/A 100/box
OZONE STERILIZATION
Ozone is a strong oxidizing agent used for low-temperature sterilization that results in no toxic fumes or residue. Ozone readily converts to oxygen which can be released into the atmosphere post process making it an environmentally friendly sterilization option.
MesaStrip
MesaStrip contains bacterial spores on a filter paper carrier sealed within a convenient, peel-open Tyvek envelope.
Dimensions: Strip 6x25mm, Tyvek envelope 45x76mm
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Item Part Number Species Population Packaging MesaStrip Ozone AOZ/6T B. atrophaeus 9372 106 100/bag MesaStrip Ozone OZA/4T B. atrophaeus 9372 104 100/bag MesaStrip Ozone AOZ/3T* B. atrophaeus 9372 103 100/bag
*Product is made to order
MESA UNIQ SPORE SUSPENSIONS
Spore Suspensions are calibrated suspensions of bacterial spores appropriate for direct inoculation of products or customers’ choice of substrate for monitoring steam, low-temperature steam, EO, dry heat, VH2O2, and irradiation or performing media growth promotion per USP.
Steam
Low-temperature Steam
38 Item Part Number Population Diluent Packaging G. stearothermophilus 7953 SSSE/4 104/0.1 mL 40% ethanol 10 mL vial SSSE/5 105/0.1 mL SSSE/6 106/0.1 mL SSGE/7 107/0.1 mL SSSA/7 107/0.1 mL Sterile Water B. smithii 51232 SSSME/7 107/0.1 mL 20% ethanol Item Part Number Population Diluent Packaging B. subtilis ‘5230’ 35021 SS5230E/4 104/0.1 mL 40% ethanol 10 mL vial SS5230E/5 105/0.1 mL SS5230E/6 106/0.1 mL SS5230E/7 107/0.1 mL SS5230E/8 108/0.1 mL SS5230A/7
107/0.1 mL Sterile Water
Ethylene Oxide and Dry Heat
Vaporized Hydrogen Peroxide
39 Item Part Number Population Diluent Packaging B. atrophaeus 9372 SSGE/4 104/0.1 mL 40% ethanol 10 mL vial SSGE/5 105/0.1 mL SSGE/6 106/0.1 mL SSGE/7 107/0.1 mL SSGE/8 108/0.1 mL Item Part Number Population Diluent Packaging G. stearothermophilus 12980 LAU-196 106 29% ethanol 10 mL vial G. stearothermophilus 7953 LPT-606 106 40% ethanol 10 mL vial Item Part Number Population Diluent Packaging C. sporogenes 7955 SSCS7955/4 104/0.1 mL 40% ethanol 10 mL vial SSCS7955/5 105/0.1 mL SSCS7955/6 106/0.1 mL SSCS7955/7 107/0.1 mL
Continued...
MESA UNIQ SPORE SUSPENSIONS
Gamma Irradiation
Growth Promotion
C.
C. sporogenes 19404
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Item Part Number Population Diluent Packaging B. pumilus 27142 SSRE/4 104/0.1 mL 40% ethanol 10 mL vial SSRE/5 105/0.1 mL SSRE/6 106/0.1 mL SSRE/7 107/0.1 mL SSRE/8 108/0.1 mL Item Part Number Population Diluent Packaging B. subtilis 6633 SS6633E/4 104/0.1 mL 40% ethanol 10 mL vial SS6633E/5 105/0.1 mL SS6633E/6 106/0.1 mL SS6633E/7 107/0.1 mL SS6633E/8 108/0.1 mL SS6633A/7 107/0.1 mL Sterile Water
SSCS11437/4 104/0.1 mL 40% ethanol SSCS11437/5 105/0.1 mL SSCS11437/6 106/0.1 mL SSCS11437/7 107/0.1 mL
sporogenes 11437
SSCS19404/4 104/0.1 mL SSCS19404/5 105/0.1 mL SSCS19404/6 106/0.1 mL
107/0.1 mL
SSCS19404/7
ACCESSORIES
Incubators
*Can be used with ExpoSure. Cannot be used with Apex EZTest.
Smart-Read Monitoring System
Smart-Well Incubator Kit (European Power) SW1710-3
Smart-Well Incubator Kit (Australian Power) SW1710-4
Smart-Well Incubator Kit (U.S. Power) SW1710-1 10 cavity + 1 control incubator, printer, power pack, cabling, and manual
Smart-Well Incubator Kit (U.K. Power) SW1710-5
Population Assay Materials
Together PAK-G and PAK-M provide the required materials for one population assay.
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Item Part Number Packaging MagnaAmp Incubator I1510 15 cavity ProSpore Incubator I1480 11 cavity EZTest Incubator* I1410 13 cavity Item Part Number Packaging
Item Part Number Packaging Glassware and Pipettes PAK-G 4 - glass bead tubes 12 - dilution tubes 2 – 10 ml pipettes 2 - 5 ml pipettes 8 - 2 ml pipettes 8 - 1 ml pipettes Growth Media PAK-M 240 ml
CHEMICAL INDICATORS
Chemical Indicators respond to one or more of the critical variables of a sterilization process and have a variety of uses. They can be used to distinguish between processes and unprocessed items, for autoclave testing or to detect the presence or attainment of multiple physical conditions. Alone chemical indicators do not confirm items are sterile but they are a necessary part of a comprehensive sterility assurance program.
For Use in the United States
Cleared for use in U.S. healthcare.
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Item Part Number Classification Modality Temperature Packaging ProChem SSW CI-SSW Type 5 Integrating Indicator Steam 121°C, 132°C, 135°C 250/box Twindicator CITWIN250 Type 4 Multivariable Indicator Steam 121 - 134°C 250/box ProChem BD CI-BDTLF Type 2 Bowie Dick Test Pack Steam 132°C 80/case ProChem BD CI-BDTLF-20 Type 2 Bowie Dick Test Pack Steam 132°C 20/box ProChem Dry Heat Indicator Labels CI-DHI Type 4 Multivariable Indicator Dry Heat 160°C 1000/box
