Apex® Biological Indicator (BI) products are designed specifically to meet the unique needs of the pharmaceutical, food, and medical device industries utilizing hydrogen peroxide (H2O2) vapor sterilization.
Our Apex® product line offers:
- The most resistant strain to HPV sterilization process to assure the manufacturing area is sterile
- Greatly reduced false positives because products match the decontamination process
- A highly flexible portfolio of BI’s to match the resistance of process parameters
Whether it be stainless steel discs/ribbons or a spore suspension, Apex® BI products offer the ideal solution to monitoring hydrogen peroxide sterilization.
Apex® Discs
- Inoculated onto grade 304 stainless steel carriers
- Discs measure 0.35″ diameter x 0.008″ thick
- Available with reference #12980, #7953 (G. stearothermophilus) or #9372 (B. atrophaeus)
- Tyvek® packaged indicators have perforations for hanging and a thumb notch for peeling
Apex® Ribbons
- Bare stainless steel ribbons measure (0.25″ x 2.75″)
- Inoculated at one end
- Available with reference #12980
- Convenient size and flexibility
Tri-Scale Biological Indicator
- One convenient Tyvek/Tyvek® package; three G. stearothermophilus populations
- Three carriers with 104, 105 and 106 spores; sealed in separate compartments
- Used for initial shakedown or validation of new enclosures or filling lines
- Convenient to identify worst-case location(s) in enclosure
Contract Studies Laboratory
We provide valuable assistance to customers in verifying the sterility of their products. Check it out here.
Testing Services
- Complete System Validations
- Propagation and Resistance Testing of Environmental Isolates
Apex® Vaporized Hydrogen Peroxide Biological Indicators
| Spore | Incubation | Population | Units | Reorder # |
|
G. stearothermophilus
|
7 days at 55 – 60°C
|
106
|
100
|
HMV-091
|
|
103
|
100
|
HMV-091E3
|
||
|
104
|
100
|
KCD-404
|
||
|
106
|
100
|
SBC-327
|
||
|
104 105106
|
50
|
LOG-456
|
||
|
106
|
100
|
NAS-152
|
||
|
B. atrophaeus
|
7 days at 30 – 35°C
|
106
|
100
|
GRS-090
|
Storage: 2 – 8°C; < 50% relative humidity
Expiration: 9 months from date of manufacture (not applicable for Apex BIs with 103 populations)
Certification: Apex biological indicators are traceable to a recognized culture collection, and certified for population and reference D-value.
Product Brochure – Vaporized Hydrogen Peroxide Biological Indicators
Product Specification – Apex Spore Suspension Geobacillus stearothermophilus 7953 or 12980
Product Specifications – Apex Discs Geobacillus stearothermophilus 7953
Product Specifications – Apex Discs Geobacillus stearothermophilus 12980
Product Specifications – Apex Ribbon Geobacillus stearothermophilus 12980
Product Specifications -Apex Discs Bacillus atrophaeus 9372
Product Specifications – Apex Disc Tri-Scale Geobacillus stearothermophilus 12980
Population Assay Instructions – Apex Products
Spore News – Proper BI Placement During VHP Decontamination Cycles
Spore News: Using Replicate BIs to Evaluate Bio-decontamination
Spore News – Parameters Effecting Vapor Hydrogen Peroxide Biological Indicator Performance