Apex Biological Indicators

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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

Using BIs in Triplicate for VHP Processes

Due to the limited penetrating capability of VHP, any presence of debris amongst the spores can also lead to spores surviving VHP exposures where kill was otherwise expected; a concept referred to as ‘‘rogue BIs’’ in various publications. To proactively combat this, Mesa and others in the industry suggest considering the use of triplicate BIs. To learn more, see our triplicate Apex BI brochure or read our Spore News article on the subject.

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ApexDiscsTriplePack2Web

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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.)