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EO Biological Indicators

Crosstex offers a wide range of Biological Indicators (BIs) used to monitor Ethylene Oxide (EO/ETO) sterilization processes.  Our BIs and Prepared Culture Media are designed to meet ISO 11138 and USP standards. Crosstex Biological Indicators for EO sterilization are:

  • Used to evaluate the efficiency of EO sterilization processes
  • Essential in performing sterilization cycle validation during EO sterilization processes
  • Easy to use and require minimal training
  • Available in different populations, packaging, and configurations. Custom BIs are also available
  • Validated with a reduced incubation time of 72 hours, when used in conjunction with Crosstex’s Prepared Culture Media (Spore Strips, Spore Discs, Spore Threads and Spore Wires)
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Spore Strips, B. atrophaeus 9372, 10x4, Glassine
BG-104

Crosstex manufactures Biological Indicators (BIs) for use in monitoring Ethylene Oxide (EO) and Dry Heat sterilization processes. Biological Indicator Spore Strips for monitoring EO and Dry Heat processes consist of: An inoculated carrier, 7 mm x 38 mm spore strip, of Bacillus atrophaeus (Cell Line 9372) Primary packaging of a white glassine pouch Products are accompanied by a Certificate of Analysis and are certified with population, purity, and resistance characteristics (D value, survival and kill where applicable) A reduced incubation time of 48 hours for Dry Heat Sterilization and 72 hours for Ethylene Oxide (EO) sterilization have been validated when Crosstex Biological Indicator Spore Strips, Discs, Threads and Wires are used in conjunction with Crosstex Prepared Culture Media (GMBTB-100)

Processes EO / Dry Heat
OrganismsBacillus atrophaeus Cell Line 9372
Indications for UseThe Spore Strips may be utilized for routine EO and Dry Heat sterilization process efficacy monitoring, sterilizer qualification testing after installation, relocation, malfunctions, major repairs and sterilization process failures for both Healthcare and Industrial applications. Crosstex Codes BG-102, BG-103, BG-104 and BG-105 are labeled For Industrial Use Only.
Strip Dimensions7 mm x 38 mm
Glassine Dimensions25 mm x 75 mm
Packaging100 Strips/Box
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements For Crosstex Codes BG-106, BG-107 and BG-108: ISO 11138-2 Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes USP <55> Biological Indicators – Resistance Performance Tests USP Biological/Official Monographs
Shelf-Life24 months from the date of manufacture
Storage Conditions15°C to 30°C, 20-70% relative humidity
Population104
Quantity100/Box
Spore Strips, B. atrophaeus 9372, 10x5, Glassine
BG-105

Crosstex manufactures Biological Indicators (BIs) for use in monitoring Ethylene Oxide (EO) and Dry Heat sterilization processes. Biological Indicator Spore Strips for monitoring EO and Dry Heat processes consist of: An inoculated carrier, 7 mm x 38 mm spore strip, of Bacillus atrophaeus (Cell Line 9372) Primary packaging of a white glassine pouch Products are accompanied by a Certificate of Analysis and are certified with population, purity, and resistance characteristics (D value, survival and kill where applicable) A reduced incubation time of 48 hours for Dry Heat Sterilization and 72 hours for Ethylene Oxide (EO) sterilization have been validated when Crosstex Biological Indicator Spore Strips, Discs, Threads and Wires are used in conjunction with Crosstex Prepared Culture Media (GMBTB-100)

Processes EO / Dry Heat
OrganismsBacillus atrophaeus Cell Line 9372
Indications for UseThe Spore Strips may be utilized for routine EO and Dry Heat sterilization process efficacy monitoring, sterilizer qualification testing after installation, relocation, malfunctions, major repairs and sterilization process failures for both Healthcare and Industrial applications. Crosstex Codes BG-102, BG-103, BG-104 and BG-105 are labeled For Industrial Use Only.
Strip Dimensions7 mm x 38 mm
Glassine Dimensions25 mm x 75 mm
Packaging100 Strips/Box
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements For Crosstex Codes BG-106, BG-107 and BG-108: ISO 11138-2 Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes USP <55> Biological Indicators – Resistance Performance Tests USP Biological/Official Monographs
Shelf-Life24 months from the date of manufacture
Storage Conditions15°C to 30°C, 20-70% relative humidity
Population105
Quantity100/Box
Spore Strips, B. atrophaeus 9372, 10x6, Glassine
BG-106

Crosstex manufactures Biological Indicators (BIs) for use in monitoring Ethylene Oxide (EO) and Dry Heat sterilization processes. Biological Indicator Spore Strips for monitoring EO and Dry Heat processes consist of: An inoculated carrier, 7 mm x 38 mm spore strip, of Bacillus atrophaeus (Cell Line 9372) Primary packaging of a white glassine pouch Products are accompanied by a Certificate of Analysis and are certified with population, purity, and resistance characteristics (D value, survival and kill where applicable) A reduced incubation time of 48 hours for Dry Heat Sterilization and 72 hours for Ethylene Oxide (EO) sterilization have been validated when Crosstex Biological Indicator Spore Strips, Discs, Threads and Wires are used in conjunction with Crosstex Prepared Culture Media (GMBTB-100)

Processes EO / Dry Heat
OrganismsBacillus atrophaeus Cell Line 9372
Indications for UseThe Spore Strips may be utilized for routine EO and Dry Heat sterilization process efficacy monitoring, sterilizer qualification testing after installation, relocation, malfunctions, major repairs and sterilization process failures for both Healthcare and Industrial applications. Crosstex Codes BG-102, BG-103, BG-104 and BG-105 are labeled For Industrial Use Only.
Strip Dimensions7 mm x 38 mm
Glassine Dimensions25 mm x 75 mm
Packaging100 Strips/Box
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements For Crosstex Codes BG-106, BG-107 and BG-108: ISO 11138-2 Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes USP <55> Biological Indicators – Resistance Performance Tests USP Biological/Official Monographs
Shelf-Life24 months from the date of manufacture
Storage Conditions15°C to 30°C, 20-70% relative humidity
Population106
Quantity100/Box
Spore Discs, B. atrophaeus 9372,6mm, 10x6, Bulk
BG-106D

Crosstex Inoculated Carrier Spore Discs for monitoring Ethylene Oxide (EO) and Dry Heat processes consist of: An inoculated carrier, 3 mm or 6 mm disc, of Bacillus atrophaeus (Cell Line 9372) Primary packaging in bulk The Spore Discs will fit into small areas of a device where a standard-sized spore strip cannot be used, such as within a syringe barrel, inside tubing and vials or under a cap A reduced incubation time of 48 hours for Dry Heat Sterilization and 72 hours for Ethylene Oxide (EO) sterilization have been validated when Crosstex Biological Indicator Spore Strips, Discs, Threads and Wires are used in conjunction with Crosstex Prepared Culture Media (GMBTB-100)

Process EO / Dry Heat
OrganismBacillus atrophaeus Cell Line 9372
Indications for UseThe Spore Discs are designed to be placed directly into a device and utilized to monitor EO and Dry Heat sterilization process efficacy. The Spore Discs are labeled For Industrial Use Only.
Disc DimensionsBG-106D: 6 mm DN18-06: 3 mm
Packaging100 Discs/Box
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements ISO 11138-2 Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes USP <55> Biological Indicators – Resistance Performance Tests USP Biological/Official Monographs
Shelf LifeBG-106D: 24 months from the date of manufacture DN18-06: 30 months from the date of manufacture
Storage ConditionsBG-106D: 20°C to 25°C average. Excursions 15°C to 30°C allowed. 20% to 70% Relative Humidity DN18-06: 15°C to 30°C, 20-80% relative humidity
Population106
Quantity100/Box
Bio ind bac atro 7log glas 100 pces
BG-107

Crosstex manufactures Biological Indicators (BIs) for use in monitoring Ethylene Oxide (EO) and Dry Heat sterilization processes. Biological Indicator Spore Strips for monitoring EO and Dry Heat processes consist of: An inoculated carrier, 7 mm x 38 mm spore strip, of Bacillus atrophaeus (Cell Line 9372) Primary packaging of a white glassine pouch Products are accompanied by a Certificate of Analysis and are certified with population, purity, and resistance characteristics (D value, survival and kill where applicable) A reduced incubation time of 48 hours for Dry Heat Sterilization and 72 hours for Ethylene Oxide (EO) sterilization have been validated when Crosstex Biological Indicator Spore Strips, Discs, Threads and Wires are used in conjunction with Crosstex Prepared Culture Media (GMBTB-100)

Processes EO / Dry Heat
OrganismsBacillus atrophaeus Cell Line 9372
Indications for UseThe Spore Strips may be utilized for routine EO and Dry Heat sterilization process efficacy monitoring, sterilizer qualification testing after installation, relocation, malfunctions, major repairs and sterilization process failures for both Healthcare and Industrial applications. Crosstex Codes BG-102, BG-103, BG-104 and BG-105 are labeled For Industrial Use Only.
Strip Dimensions7 mm x 38 mm
Glassine Dimensions25 mm x 75 mm
Packaging100 Strips/Box
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements For Crosstex Codes BG-106, BG-107 and BG-108: ISO 11138-2 Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes USP <55> Biological Indicators – Resistance Performance Tests USP Biological/Official Monographs
Shelf-Life24 months from the date of manufacture
Storage Conditions15°C to 30°C, 20-70% relative humidity
Population107
Quantity100/Box
Spore Discs, B. atrophaeus 9372,3mm, 10x6, Bulk
DN18-06

Crosstex Inoculated Carrier Spore Discs for monitoring Ethylene Oxide (EO) and Dry Heat processes consist of: An inoculated carrier, 3 mm or 6 mm disc, of Bacillus atrophaeus (Cell Line 9372) Primary packaging in bulk The Spore Discs will fit into small areas of a device where a standard-sized spore strip cannot be used, such as within a syringe barrel, inside tubing and vials or under a cap A reduced incubation time of 48 hours for Dry Heat Sterilization and 72 hours for Ethylene Oxide (EO) sterilization have been validated when Crosstex Biological Indicator Spore Strips, Discs, Threads and Wires are used in conjunction with Crosstex Prepared Culture Media (GMBTB-100)

Process EO / Dry Heat
OrganismBacillus atrophaeus Cell Line 9372
Indications for UseThe Spore Discs are designed to be placed directly into a device and utilized to monitor EO and Dry Heat sterilization process efficacy. The Spore Discs are labeled For Industrial Use Only.
Disc DimensionsBG-106D: 6 mm DN18-06: 3 mm
Packaging100 Discs/Box
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements ISO 11138-2 Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes USP <55> Biological Indicators – Resistance Performance Tests USP Biological/Official Monographs
Shelf LifeBG-106D: 24 months from the date of manufacture DN18-06: 30 months from the date of manufacture
Storage ConditionsBG-106D: 20°C to 25°C average. Excursions 15°C to 30°C allowed. 20% to 70% Relative Humidity DN18-06: 15°C to 30°C, 20-80% relative humidity
Population106
Quantity100/Box
SporeView®, B. atrophaeus 9372 (EO) 10x6
SCA-100

Crosstex’s SporeView® Self-Contained Biological Indicators (SCBIs) for monitoring Ethylene Oxide (EO) sterilization consist of a thermoplastic vial and a green cap, a crushable glass ampule with an exclusively formulated Trypticase® Soy Broth (TSB) modified with pH indicator, and a disc inoculated with Bacillus atrophaeus spores. Reduced incubation time of 48 hours Visually distinct positive results indicated by the media transitioning from Green to Yellow Chemical Indicator on label provides instant indication of exposure Compliant with ISO 11138-1 and 11138-2 SporView® is a registered trademark of SPSmedical Supply Corp., a wholly owned subsidiary of Crosstex International, Inc. Trypticase® is a registered trademark owned by Becton, Dickinson and Company.

Process EO
OrganismBacillus atrophaeus Cell Line 9372
Indications for UseThe SporView® may be utilized to monitor EO sterilization processes. This product is labeled For Industrial Use Only.
Incubation Time48 hours
Chemical IndicatorEach SCBI vial label contains a Chemical Indicator for instant indication of exposure.
MSCBI Dimensions8.4 mm x 45.5 mm
Packaging100 SCBIs/Box
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements ISO 11138-2 Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes USP
Shelf-LifeTypically 24 months. The shelf life of the MSCBIs is based on the shorter of the two individual components (the media ampoule and inoculated carrier), which have independent expiration periods
Storage Conditions15°C to 30°C, 20-70% relative humidity
Population106
Quantity100/Box
Traditional SCBI, B. atrophaeus 9372 (EO) 10x6
SCE-06

Crosstex’s Traditional Self-Contained Biological Indicators (SCBIs) for monitoring Ethylene Oxide (EO) sterilization consist of a durable polycarbonate vial with cap, a crushable glass ampoule with Tryptic Soy Broth (TSB) modified with pH indicator, and a disc inoculated with Bacillus atrophaeus spores. Reduced incubation time of 72 hours Visually distinct positive results indicated by the media transitioning from Green to Yellow Chemical Indicator on label provides instant indication of exposure

Process EO
OrganismBacillus atrophaeus Cell Line 9372
Indications for UseThe SCBIs may be utilized to monitor EO sterilization processes. This product is labeled For Industrial Use Only.
Incubation Time48 hours
Chemical IndicatorEach SCBI vial label contains a Chemical Indicator for instant indication of exposure.
SCBI Dimensions13 mm x 61 mm
Packaging50 SCBIs/Box
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements ISO 11138-2 Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes USP
Shelf-LifeThe shelf life of the SCBIs is based on the shorter of the two individual components (the media ampoule and inoculated carrier), which have independent expiration periods.
Storage Conditions15°C to 30°C, 20-70% relative humidity
Population106
Quantity50/Box
Bio ind mini b atro 6l glas 100 pces
STN-062

Crosstex Biological Indicator Mini Spore Strips for monitoring Ethylene Oxide (EO) and Dry Heat processes consist of: An inoculated carrier, 2 mm x 10 mm strip, of Bacillus atrophaeus (Cell Line 9372) Primary packaging either in bulk (STN-062B), a glassine envelope (STN-062) or a mini glassine envelope (STN-062MG) A reduced incubation time of 48 hours for Dry Heat Sterilization and 72 hours for Ethylene Oxide (EO) sterilization have been validated when Crosstex Biological Indicator Spore Strips, Discs, Threads and Wires are used in conjunction with Crosstex Prepared Culture Media (GMBTB-100)

Process EO / Dry Heat
OrganismBacillus atrophaeus Cell Line 9372
Indications for UseThe Mini Spore Strips may be utilized to monitor EO and Dry Heat sterilization process efficacy. The Mini Spore Strips are labeled For Industrial Use Only.
Strip Dimensions2 mm x 10 mm
Glassine DimensionsSTN-062: 25 mm x 50 mm STN-062MG: 25 mm x 25 mm
Packaging100 Strips/Box
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements ISO 11138-2 Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes USP <55> Biological Indicators – Resistance Performance Tests USP Biological/Official Monographs
Shelf Life30 months from the date of manufacture
Storage Conditions15°C to 30°C, 20-70% relative humidity
PackagingGlassine envelope
Quantity100/Box
Mini Spore Strips, B. atrophaeus 9372, 2x10mm, Bulk
STN-062B

Crosstex Biological Indicator Mini Spore Strips for monitoring Ethylene Oxide (EO) and Dry Heat processes consist of: An inoculated carrier, 2 mm x 10 mm strip, of Bacillus atrophaeus (Cell Line 9372) Primary packaging either in bulk (STN-062B), a glassine envelope (STN-062) or a mini glassine envelope (STN-062MG) A reduced incubation time of 48 hours for Dry Heat Sterilization and 72 hours for Ethylene Oxide (EO) sterilization have been validated when Crosstex Biological Indicator Spore Strips, Discs, Threads and Wires are used in conjunction with Crosstex Prepared Culture Media (GMBTB-100)

Process EO / Dry Heat
OrganismBacillus atrophaeus Cell Line 9372
Indications for UseThe Mini Spore Strips may be utilized to monitor EO and Dry Heat sterilization process efficacy. The Mini Spore Strips are labeled For Industrial Use Only.
Strip Dimensions2 mm x 10 mm
Glassine DimensionsSTN-062: 25 mm x 50 mm STN-062MG: 25 mm x 25 mm
Packaging100 Strips/Box
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements ISO 11138-2 Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes USP <55> Biological Indicators – Resistance Performance Tests USP Biological/Official Monographs
Shelf Life30 months from the date of manufacture
Storage Conditions15°C to 30°C, 20-70% relative humidity
PackagingBulk
Quantity100/Box
Mini Spore Strips, B. atrophaeus 9372, 2x10mm, Mini Glassine
STN-062MG

Crosstex Biological Indicator Mini Spore Strips for monitoring Ethylene Oxide (EO) and Dry Heat processes consist of: An inoculated carrier, 2 mm x 10 mm strip, of Bacillus atrophaeus (Cell Line 9372) Primary packaging either in bulk (STN-062B), a glassine envelope (STN-062) or a mini glassine envelope (STN-062MG) A reduced incubation time of 48 hours for Dry Heat Sterilization and 72 hours for Ethylene Oxide (EO) sterilization have been validated when Crosstex Biological Indicator Spore Strips, Discs, Threads and Wires are used in conjunction with Crosstex Prepared Culture Media (GMBTB-100)

Process EO / Dry Heat
OrganismBacillus atrophaeus Cell Line 9372
Indications for UseThe Mini Spore Strips may be utilized to monitor EO and Dry Heat sterilization process efficacy. The Mini Spore Strips are labeled For Industrial Use Only.
Strip Dimensions2 mm x 10 mm
Glassine DimensionsSTN-062: 25 mm x 50 mm STN-062MG: 25 mm x 25 mm
Packaging100 Strips/Box
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements ISO 11138-2 Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes USP <55> Biological Indicators – Resistance Performance Tests USP Biological/Official Monographs
Shelf Life30 months from the date of manufacture
Storage Conditions15°C to 30°C, 20-70% relative humidity
PackagingMini glassine envelope
Quantity100/Box
Cotton Thread, B atrophaeus 9372, 25x0,1mm, 10x6, Bulk
THN-06

Crosstex offers specialized Spore Threads (cotton) and Spore Wires (steel) for Ethylene Oxide (EO) Sterilization inoculated with Bacillus atrophaeus (Cell Line 9372) spores. Ideal for use in tubing, lumens and other devices/instruments where larger BIs and carriers cannot be utilized Crosstex’s manufacturing process is designed to ensure that the entire length of the threads and wires contains a consistent number of spores Spore Wires have a rigid structure which allows for easy insertion and removal from a device The steel construction in our Spore Wires does not absorb moisture which is ideal when there is condensation within the lumen A reduced incubation time of 72 hours for Ethylene Oxide (EO) sterilization have been validated when used in conjunction with Crosstex Prepared Culture Media (GMBTB-100)

Process EO
OrganismBacillus atrophaeus Cell Line 9372
Indications for UseThe Spore Threads and Spore Wires may be utilized to monitor EO sterilization processes. This product is labeled For Industrial Use Only.
DimensionsTHN-06 (Threads): 25 mm x 0.1 mm SWN-06 (Wires): 40 mm x 1.5 mm
Packaging100 Threads or Wires/Box
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements ISO 11138-2 Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes USP
Shelf-LifeTHN-06 (Threads): 24 months from the date of manufacture SWN-06 (Wires): 12 months from the date of manufacture
Storage Conditions15°C to 30°C, 20-70% relative humidity
DescriptionCotton Thread (25 mm x 0.1 mm)
PackagingBulk
Pop.106
Quantity100 Threads/Box
Cotton Thread, B atrophaeus 9372, 25x0,1mm, 10x6, Glassine
THN-06P

Crosstex offers specialized Spore Threads (cotton) and Spore Wires (steel) for Ethylene Oxide (EO) Sterilization inoculated with Bacillus atrophaeus (Cell Line 9372) spores. Ideal for use in tubing, lumens and other devices/instruments where larger BIs and carriers cannot be utilized Crosstex’s manufacturing process is designed to ensure that the entire length of the threads and wires contains a consistent number of spores Spore Wires have a rigid structure which allows for easy insertion and removal from a device The steel construction in our Spore Wires does not absorb moisture which is ideal when there is condensation within the lumen A reduced incubation time of 72 hours for Ethylene Oxide (EO) sterilization have been validated when used in conjunction with Crosstex Prepared Culture Media (GMBTB-100)

Process EO
OrganismBacillus atrophaeus Cell Line 9372
Indications for UseThe Spore Threads and Spore Wires may be utilized to monitor EO sterilization processes. This product is labeled For Industrial Use Only.
DimensionsTHN-06 (Threads): 25 mm x 0.1 mm SWN-06 (Wires): 40 mm x 1.5 mm
Packaging100 Threads or Wires/Box
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements ISO 11138-2 Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes USP
Shelf-LifeTHN-06 (Threads): 24 months from the date of manufacture SWN-06 (Wires): 12 months from the date of manufacture
Storage Conditions15°C to 30°C, 20-70% relative humidity
DescriptionCotton Thread (25 mm x 0.1 mm)
PackagingGlassine
Pop.106
Quantity100 Threads/Box
Spore suspen b atropheus 9372 2log 10ml
VBA-102

Crosstex manufactures a wide range of Spore Suspensions utilized in Ethylene Oxide (EO) and Dry Heat sterilization processes. The Spore Suspensions are pure suspensions of spores with known resistance characteristics and a variety of population levels standardized per 0.1 mL. The Spore Suspensions allow for direct inoculation of products, typically to verify sterility of devices where a traditional biological indicator spore strip cannot be used. They can also be used for a variety of other microbiological tests including cleaning effectiveness studies, Bioburden percent recovery and Bacteriostasis/Fungistasis (BF) testing. Each vial contains 10 mL of suspension. Diluent contains 20% ethanol Pharmaceutical grade glass vials with screw cap and septum Spore Suspensions require storage under refrigerated conditions (2°C to 8°C) Each vial of Spore Suspension is accompanied by a Certificate of Analysis detailing the source, assayed population, resistance characteristics on paper carrier and expiration date ISO 11138-1 Compliant

Process EO / Dry Heat
OrganismBacillus atrophaeus Cell Line 9372
Indications for UseCrosstex Spore Suspensions are standardized suspensions of spores appropriate for direct inoculation onto samples for sterility, bioburden, and bacteriostasis testing. Spore Suspensions are labeled For Industrial Use Only.
Suspension Volume10 mL Diluent contains 20% ethanol
PackagingPharmaceutical grade glass vial with screw cap and septum
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements USP (where applicable)
Shelf Life18 months from the date of manufacture
Storage ConditionsRefrigerate at 2°C to 8°C
Population per 0.1 mL102
Spore suspen b atropheus 9372 10x3 10ml
VBA-103

Crosstex manufactures a wide range of Spore Suspensions utilized in Ethylene Oxide (EO) and Dry Heat sterilization processes. The Spore Suspensions are pure suspensions of spores with known resistance characteristics and a variety of population levels standardized per 0.1 mL. The Spore Suspensions allow for direct inoculation of products, typically to verify sterility of devices where a traditional biological indicator spore strip cannot be used. They can also be used for a variety of other microbiological tests including cleaning effectiveness studies, Bioburden percent recovery and Bacteriostasis/Fungistasis (BF) testing. Each vial contains 10 mL of suspension. Diluent contains 20% ethanol Pharmaceutical grade glass vials with screw cap and septum Spore Suspensions require storage under refrigerated conditions (2°C to 8°C) Each vial of Spore Suspension is accompanied by a Certificate of Analysis detailing the source, assayed population, resistance characteristics on paper carrier and expiration date ISO 11138-1 Compliant

Process EO / Dry Heat
OrganismBacillus atrophaeus Cell Line 9372
Indications for UseCrosstex Spore Suspensions are standardized suspensions of spores appropriate for direct inoculation onto samples for sterility, bioburden, and bacteriostasis testing. Spore Suspensions are labeled For Industrial Use Only.
Suspension Volume10 mL Diluent contains 20% ethanol
PackagingPharmaceutical grade glass vial with screw cap and septum
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements USP (where applicable)
Shelf Life18 months from the date of manufacture
Storage ConditionsRefrigerate at 2°C to 8°C
Population per 0.1 mL103
Spore suspen b atropheus 9372 10x4 10ml
VBA-104

Crosstex manufactures a wide range of Spore Suspensions utilized in Ethylene Oxide (EO) and Dry Heat sterilization processes. The Spore Suspensions are pure suspensions of spores with known resistance characteristics and a variety of population levels standardized per 0.1 mL. The Spore Suspensions allow for direct inoculation of products, typically to verify sterility of devices where a traditional biological indicator spore strip cannot be used. They can also be used for a variety of other microbiological tests including cleaning effectiveness studies, Bioburden percent recovery and Bacteriostasis/Fungistasis (BF) testing. Each vial contains 10 mL of suspension. Diluent contains 20% ethanol Pharmaceutical grade glass vials with screw cap and septum Spore Suspensions require storage under refrigerated conditions (2°C to 8°C) Each vial of Spore Suspension is accompanied by a Certificate of Analysis detailing the source, assayed population, resistance characteristics on paper carrier and expiration date ISO 11138-1 Compliant

Process EO / Dry Heat
OrganismBacillus atrophaeus Cell Line 9372
Indications for UseCrosstex Spore Suspensions are standardized suspensions of spores appropriate for direct inoculation onto samples for sterility, bioburden, and bacteriostasis testing. Spore Suspensions are labeled For Industrial Use Only.
Suspension Volume10 mL Diluent contains 20% ethanol
PackagingPharmaceutical grade glass vial with screw cap and septum
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements USP (where applicable)
Shelf Life18 months from the date of manufacture
Storage ConditionsRefrigerate at 2°C to 8°C
Population per 0.1 mL104
Spore suspen b atropheus 9372 10x5 10ml
VBA-105

Crosstex manufactures a wide range of Spore Suspensions utilized in Ethylene Oxide (EO) and Dry Heat sterilization processes. The Spore Suspensions are pure suspensions of spores with known resistance characteristics and a variety of population levels standardized per 0.1 mL. The Spore Suspensions allow for direct inoculation of products, typically to verify sterility of devices where a traditional biological indicator spore strip cannot be used. They can also be used for a variety of other microbiological tests including cleaning effectiveness studies, Bioburden percent recovery and Bacteriostasis/Fungistasis (BF) testing. Each vial contains 10 mL of suspension. Diluent contains 20% ethanol Pharmaceutical grade glass vials with screw cap and septum Spore Suspensions require storage under refrigerated conditions (2°C to 8°C) Each vial of Spore Suspension is accompanied by a Certificate of Analysis detailing the source, assayed population, resistance characteristics on paper carrier and expiration date ISO 11138-1 Compliant

Process EO / Dry Heat
OrganismBacillus atrophaeus Cell Line 9372
Indications for UseCrosstex Spore Suspensions are standardized suspensions of spores appropriate for direct inoculation onto samples for sterility, bioburden, and bacteriostasis testing. Spore Suspensions are labeled For Industrial Use Only.
Suspension Volume10 mL Diluent contains 20% ethanol
PackagingPharmaceutical grade glass vial with screw cap and septum
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements USP (where applicable)
Shelf Life18 months from the date of manufacture
Storage ConditionsRefrigerate at 2°C to 8°C
Population per 0.1 mL105
Spore suspen b atropheus 9372 6log 10ml
VBA-106

Crosstex manufactures a wide range of Spore Suspensions utilized in Ethylene Oxide (EO) and Dry Heat sterilization processes. The Spore Suspensions are pure suspensions of spores with known resistance characteristics and a variety of population levels standardized per 0.1 mL. The Spore Suspensions allow for direct inoculation of products, typically to verify sterility of devices where a traditional biological indicator spore strip cannot be used. They can also be used for a variety of other microbiological tests including cleaning effectiveness studies, Bioburden percent recovery and Bacteriostasis/Fungistasis (BF) testing. Each vial contains 10 mL of suspension. Diluent contains 20% ethanol Pharmaceutical grade glass vials with screw cap and septum Spore Suspensions require storage under refrigerated conditions (2°C to 8°C) Each vial of Spore Suspension is accompanied by a Certificate of Analysis detailing the source, assayed population, resistance characteristics on paper carrier and expiration date ISO 11138-1 Compliant

Process EO / Dry Heat
OrganismBacillus atrophaeus Cell Line 9372
Indications for UseCrosstex Spore Suspensions are standardized suspensions of spores appropriate for direct inoculation onto samples for sterility, bioburden, and bacteriostasis testing. Spore Suspensions are labeled For Industrial Use Only.
Suspension Volume10 mL Diluent contains 20% ethanol
PackagingPharmaceutical grade glass vial with screw cap and septum
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements USP (where applicable)
Shelf Life18 months from the date of manufacture
Storage ConditionsRefrigerate at 2°C to 8°C
Population per 0.1 mL106
Spore suspen b atropheus 9372 7log 10ml
VBA-107

Crosstex manufactures a wide range of Spore Suspensions utilized in Ethylene Oxide (EO) and Dry Heat sterilization processes. The Spore Suspensions are pure suspensions of spores with known resistance characteristics and a variety of population levels standardized per 0.1 mL. The Spore Suspensions allow for direct inoculation of products, typically to verify sterility of devices where a traditional biological indicator spore strip cannot be used. They can also be used for a variety of other microbiological tests including cleaning effectiveness studies, Bioburden percent recovery and Bacteriostasis/Fungistasis (BF) testing. Each vial contains 10 mL of suspension. Diluent contains 20% ethanol Pharmaceutical grade glass vials with screw cap and septum Spore Suspensions require storage under refrigerated conditions (2°C to 8°C) Each vial of Spore Suspension is accompanied by a Certificate of Analysis detailing the source, assayed population, resistance characteristics on paper carrier and expiration date ISO 11138-1 Compliant

Process EO / Dry Heat
OrganismBacillus atrophaeus Cell Line 9372
Indications for UseCrosstex Spore Suspensions are standardized suspensions of spores appropriate for direct inoculation onto samples for sterility, bioburden, and bacteriostasis testing. Spore Suspensions are labeled For Industrial Use Only.
Suspension Volume10 mL Diluent contains 20% ethanol
PackagingPharmaceutical grade glass vial with screw cap and septum
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements USP (where applicable)
Shelf Life18 months from the date of manufacture
Storage ConditionsRefrigerate at 2°C to 8°C
Population per 0.1 mL107
Spore suspen b atropheus 9372 10x8 10ml
VBA-108

Crosstex manufactures a wide range of Spore Suspensions utilized in Ethylene Oxide (EO) and Dry Heat sterilization processes. The Spore Suspensions are pure suspensions of spores with known resistance characteristics and a variety of population levels standardized per 0.1 mL. The Spore Suspensions allow for direct inoculation of products, typically to verify sterility of devices where a traditional biological indicator spore strip cannot be used. They can also be used for a variety of other microbiological tests including cleaning effectiveness studies, Bioburden percent recovery and Bacteriostasis/Fungistasis (BF) testing. Each vial contains 10 mL of suspension. Diluent contains 20% ethanol Pharmaceutical grade glass vials with screw cap and septum Spore Suspensions require storage under refrigerated conditions (2°C to 8°C) Each vial of Spore Suspension is accompanied by a Certificate of Analysis detailing the source, assayed population, resistance characteristics on paper carrier and expiration date ISO 11138-1 Compliant

Process EO / Dry Heat
OrganismBacillus atrophaeus Cell Line 9372
Indications for UseCrosstex Spore Suspensions are standardized suspensions of spores appropriate for direct inoculation onto samples for sterility, bioburden, and bacteriostasis testing. Spore Suspensions are labeled For Industrial Use Only.
Suspension Volume10 mL Diluent contains 20% ethanol
PackagingPharmaceutical grade glass vial with screw cap and septum
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements USP (where applicable)
Shelf Life18 months from the date of manufacture
Storage ConditionsRefrigerate at 2°C to 8°C
Population per 0.1 mL108

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