Apex Biological Indicators         

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

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.

Gaseous Hydrogen Peroxide Systems Products and Services

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Apex Discs

• Packaged in Tyvek/Tyvek®

• Discs measure 0.35" diameter x 0.008" thick

• Available with reference #12980 or #7953

• 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 or #7953 
• Convenient size and flexibility

Tri-Scale BI (Reorder #LOG-456) features:

• Based on grade 304 stainless steel carriers; no residuals issues
• One convenient Tyvek¹/Tyvek package; three G. stearothermophilus populations  
• Three carriers respectively inoculated with >1x10⁴, >1x10⁵ and >1x10⁶ 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:

1. Place Tri-Scale BIs in selected sites throughout test enclosure
2. Conduct an exposure time estimated to be near the 6 log reduction point
3. Retrieve Tri-Scale BIs, culture, and observe for outgrowth
4. Based on outgrowth patterns, identify worst-case location(s) in enclosure
5. Use fractional outgrowth results to estimate a probable 6 log reduction cycle 

For example, a location where the 1x10⁵ and 1x10⁶ carriers grew had adequate sterilant to kill 1x10⁴ spores, but not 1x10⁵ spores, and will require a longer cycle to ensure sterilization of this location.

Microbial Suspensions

• G. stearothermophilus for gaseous hydrogen peroxide
• B. subtilis for liquid peroxide systems
• Custom applications and custom preparations

Testing Services

• Complete System Validations
• Propagation and Resistance Testing of Environmental Isolates