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Gamma & E-Beam Biological Indicators

Crosstex is an industry leader manufacturing Biological Indicators (BIs) used to monitor Gamma & E-Beam sterilization processes. Our BIs are designed to meet ISO 11138 and USP standards. Crosstex Biological Indicators for Gamma & E-Beam sterilization are:

  • Used world-wide and designed to evaluate the effectiveness of Gamma & E-Beam sterilization processes
  • Critical in performing sterilization cycle validation during Gamma & E-Beam sterilization processes
  • Available in different populations, packaging, and configurations. Our BIs can also be custom designed to fulfill your requirements
  • Easy to use and minimal training is required
Number of articles 6
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Spore Strips B. pumilus 27142 10x6
PM-106

Crosstex offers Biological Indicators (BIs) for use in monitoring Gamma & E-Beam sterilization processes.

Our biological indicators are manufactured using precise care, which provides assurance that each glassine pouch contains a biological indicator consistent in population, purity and resistance. Inoculated filter paper, each 7 mm x 38 mm, individually packaged in easy-to-handle glassine pouches

The strips can be easily removed from the glassine pouch by tearing open for transfer to culture media or challenge device assembly

Convenient shelf packages of 100 units per box.

Products are accompanied by a Certificate of Analysis and are certified with population, purity, and resistance characteristics.

Compliant with ISO 11138-1

Process Radiation (Gamma and E-Beam)
Organism Bacillus pumilus Cell Line 27142
Indications for Use The Spore Strips may be utilized to monitor Gamma and E-Beam Radiation sterilization processes. This product is labeled For Industrial Use Only.
Strip Dimensions 7 mm x 38 mm (1.5” x 0.281”)
Glassine Dimensions 25 mm x 75 mm
Packaging 100 Strips/Box
Compliance ISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements USP
Shelf-Life 24 months from the date of manufacture
Storage Conditions 15°C to 30°C, 20-70% relative humidity
Population 106
Quantity 100/Box
Spore Strips B. pumilus 27142 10x7
PM-107

Crosstex offers Biological Indicators (BIs) for use in monitoring Gamma & E-Beam sterilization processes. Our biological indicators are manufactured using precise care, which provides assurance that each glassine pouch contains a biological indicator consistent in population, purity and resistance. Inoculated filter paper, each 7 mm x 38 mm, individually packaged in easy-to-handle glassine pouches The strips can be easily removed from the glassine pouch by tearing open for transfer to culture media or challenge device assembly Convenient shelf packages of 100 units per box Products are accompanied by a Certificate of Analysis and are certified with population, purity, and resistance characteristics Compliant with ISO 11138-1

Process Radiation (Gamma and E-Beam)
OrganismBacillus pumilus Cell Line 27142
Indications for UseThe Spore Strips may be utilized to monitor Gamma and E-Beam Radiation sterilization processes. This product is labeled For Industrial Use Only.
Strip Dimensions7 mm x 38 mm (1.5” x 0.281”)
Glassine Dimensions25 mm x 75 mm
Packaging100 Strips/Box
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements USP
Shelf-Life24 months from the date of manufacture
Storage Conditions15°C to 30°C, 20-70% relative humidity
Population107
Quantity100/Box
Spore Strips B. pumilus 27142 10x8
PM-108

Crosstex offers Biological Indicators (BIs) for use in monitoring Gamma & E-Beam sterilization processes. Our biological indicators are manufactured using precise care, which provides assurance that each glassine pouch contains a biological indicator consistent in population, purity and resistance. Inoculated filter paper, each 7 mm x 38 mm, individually packaged in easy-to-handle glassine pouches The strips can be easily removed from the glassine pouch by tearing open for transfer to culture media or challenge device assembly Convenient shelf packages of 100 units per box Products are accompanied by a Certificate of Analysis and are certified with population, purity, and resistance characteristics Compliant with ISO 11138-1

Process Radiation (Gamma and E-Beam)
OrganismBacillus pumilus Cell Line 27142
Indications for UseThe Spore Strips may be utilized to monitor Gamma and E-Beam Radiation sterilization processes. This product is labeled For Industrial Use Only.
Strip Dimensions7 mm x 38 mm (1.5” x 0.281”)
Glassine Dimensions25 mm x 75 mm
Packaging100 Strips/Box
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements USP
Shelf-Life24 months from the date of manufacture
Storage Conditions15°C to 30°C, 20-70% relative humidity
Population108
Quantity100/Box
Spore suspension b. pumilus 27142 10x6, 10ml
VBP-106

Crosstex manufactures Spore Suspensions utilized in Gamma & E-Beam sterilization processes.

The Spore Suspensions are pure suspensions of spores with known radiation 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.

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 Radiation (Gamma and E-Beam)
Organism Bacillus pumilus Cell Line 27142
Indications for Use Crosstex Spore Suspensions are standardized suspensions of spores appropriate for direct inoculation onto samples for sterility, bioburden, and bacteriostasis testing. This product is labeled For Industrial Use Only.
Suspension Volume 10 mL Diluent contains 20% Ethanol
Packaging Pharmaceutical grade glass vial with screw cap and septum
Compliance ISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements USP
Shelf Life 24 months from the date of manufacture
Storage Conditions Refrigerate at 2°C to 8°C
Population per 0.1 mL 106
Spore suspension b. pumilus 27142 10x7, 10ml
VBP-107

Crosstex manufactures Spore Suspensions utilized in Gamma & E-Beam sterilization processes.

The Spore Suspensions are pure suspensions of spores with known radiation 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.

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 Radiation (Gamma and E-Beam)
Organism Bacillus pumilus Cell Line 27142
Indications for Use Crosstex Spore Suspensions are standardized suspensions of spores appropriate for direct inoculation onto samples for sterility, bioburden, and bacteriostasis testing. This product is labeled For Industrial Use Only.
Suspension Volume 10 mL Diluent contains 20% Ethanol
Packaging Pharmaceutical grade glass vial with screw cap and septum
Compliance ISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements USP
Shelf Life 24 months from the date of manufacture
Storage Conditions Refrigerate at 2°C to 8°C
Population per 0.1 mL 107
Spore suspension b. pumilus 27142 10x8, 10ml
VBP-108

Crosstex manufactures Spore Suspensions utilized in Gamma & E-Beam sterilization processes.

The Spore Suspensions are pure suspensions of spores with known radiation 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.

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 Radiation (Gamma and E-Beam)
Organism Bacillus pumilus Cell Line 27142
Indications for Use Crosstex Spore Suspensions are standardized suspensions of spores appropriate for direct inoculation onto samples for sterility, bioburden, and bacteriostasis testing. This product is labeled For Industrial Use Only.
Suspension Volume 10 mL Diluent contains 20% Ethanol
Packaging Pharmaceutical grade glass vial with screw cap and septum
Compliance ISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements USP
Shelf Life 24 months from the date of manufacture
Storage Conditions Refrigerate at 2°C to 8°C
Population per 0.1 mL 108

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