Apex Biological Indicator products are designed specifically for the pharmaceutical, food and medical device industries utilizing H2O2 vapor sterilization. The stainless steel carrier material is designed for use with today’s isolator and filling line applications.
Whether it be stainless steel discs/ribbons or a spore suspension, Apex BI products offer the ideal solution to monitoring hydrogen peroxide sterilization.
The Apex line of biological indicators is specifically designed to meet the unique needs of the medical device and pharmaceutical industries. The Apex name has long been associated with quality and ingenuity and Mesa has incorporated these aspects into its line of Apex Biological Indicators.
- Grade 304 stainless steel carrier is non-absorptive – no H202 residuals
- Thin carrier (0.008″ thick) warms and cools rapidly with chamber variations
- Minimum 1.0 x 106 spores per carrier
Gaseous Hydrogen Peroxide Systems Products and Services
Apex Discs
- Packaged in Tyvek/Tyvek®
- Discs measure 0.35″ diameter x 0.008″ thick
- Available with reference #12980, #7953 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 BI (Reorder #LOG-456) features:
- Based on grade 304 stainless steel carriers; no residuals issues
- One convenient Tyvek/Tyvek® package; three G. stearothermophilus populations
- Three carriers respectively inoculated with >1×104, >1×105 and >1×106 spores and sealed in separate compartments
- Thumb notch for peeling; perforated for hanging
Uses
- Initial shakedown or validation of new enclosures or filling lines
- Evaluating large or uniquely configured enclosures
- Studying systems with unknown gas distribution dynamics
- Enclosure validations with multiple load configurations
- Routine monitoring of identified worst-case enclosure locations
General Method
- Place Tri-Scale BIs in selected sites throughout test enclosure
- Conduct an exposure time estimated to be near the 6 log reduction point
- Retrieve Tri-Scale BIs, culture, and observe for outgrowth
- Based on outgrowth patterns, identify worst-case location(s) in enclosure
- Use fractional outgrowth results to estimate a probable 6 log reduction cycle
- (For example, a location where the 1×105 and 1×106 carriers grew had adequate sterilant to kill 1×104 spores, but not 1×105 spores, and will require a longer cycle to ensure sterilization of this location.)
Microbial Suspensions
- G. stearothermophilus for gaseous hydrogen peroxide
- Custom applications and custom preparations
Testing Services
- Complete System Validations
- Propagation and Resistance Testing of Environmental Isolates
Technical Specifications
Apex BI Dimensions
Disc Diameter: 0.35 inch/8.89 mm
Thickness: 0.008 inches/0.2032 mm
Ribbon Size: 2.75 inches/69.85 mm x 0.25 inches/6.35 mm
Thickness: 0.003 inches/0.0762 mm
Tyvek Pouch: 2.5 inches/63.5 mm x 1.125 inches / 25.575 mm
| Product Tri-Scale Apex Discs Apex Ribbons | Species G. stearothermophilus G. stearothermophilus G. stearothermophilus | Sets/box 50 100 100 | Population Sets of Log 4, 5 and 6 Log 4, 5 or 6 Log 4, 5 or 6 | Reorder LOG-456 HMV-091 SBC-327 |