•  Biological Indicators

Biological Indicators

for Gaseous Hydrogen Peroxide Sterilization

Apex Biological Indicator products are designed specifically  for the phamaceutical, food and medical device industries utilizing H2O2 vapor sterillization. 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

The stainless steel carrier materials is designed for use  with today's isolator and filling line applications.

Apex Discs
  • Packaged in Tyvex/Tyvex-1
  • Discs measure 0.35" diameter x 0.008" thick
  • Tyvek packged indicators have perforations for hanging and a thumb notch for peeling
  • Available with reference #12980 or #7953

1. Tyvex is a registered trademark of DuPont Corporation.


Apex Ribbon
  • Bare stainless steel ribbons measure (0.25" x 2.75")
  • Inoculated at one end
  • Convenient size and flexibility


Key features and benefits
  • Grade 304 stainless steel carrier is non-absorptive - no H2O2 residuals
  • Thin carrier (0.008" thick) warms and cools rapidly with chamber variations
  • Minimum 1.0 x 106 spores per carrier


Tri-Scales Biological Indicator for Hydrogen Peroxide
(US Patent #5,856,118)
Tri-Scale BI (Reorder #LOG-456) Features
  • Based on grade 304 stainless steel carriers; no residuals issues
  • One convenient Tyvex1/Tyvex packgae; Three G. stearothermophilus populations
  • Three carriers respectively innoculated with > 1 x 104, >1 x 105 and >1 x 106 spore and sealed in separate comportments
  • Thumbs notch for peeling; perforated for hanging
  • Initial shakedown or validations 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
  • Retrive Tri-Scale BIs, culture, and observe for outgrowth
  • Based on outgrowth pattern, identify worst-case locations(s) in enclosure
  • Use fractional outgrowth result to estimate a probable 6 log reduction cycle
For example, a location where the 1 x 105 and 1 x 106 carriers grew had adequate sterilant to kill 1 x 104 spores, but not 1 x 105 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


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