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
| ||
106
| 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
Certification: Apex biological indicators are traceable to a recognized culture collection, and certified for population and reference D-value.