Population Assay (Biological Indicator Population Verification)

Geobacillus stearothermophilus

Bacillus atrophaeus

Bacillus pumilus

Cycle Development/Validation

Steam (Gravity Displacement and Pre-vacuum)

Ethylene Oxide Gas (100% and mixture)

Gas Plasma (STERRAD® 100 GMP, 100S, NX)

Peracetic Acid (STERIS SYSTEM 1®)

Dry Heat (Static Air and Rapid Heat)

Chemical Vapor (Chemiclave®)

D-Value Determination
Biological Indicator Survival/Kill Verification
Device Degradation (Repeat Sterilization Cycle Testing)
Materials Compatibility
Product Sterility Testing
Burst Testing
Shelf-Life Testing
Package Integrity Testing
Research & Development
Sterilization Consulting Services
Resistometer (BIER vessel) Testing

Chemical Indicator Testing

ISO 11140

Cleaning Validation for AAMI TIR 12

Validation Studies

Sterilizers

Mechanical Cleaners

Medical or Dental Instruments

Rigid Containers, Organizing Trays or Cassettes

Reusable or Single-Use Packaging Materials

STERRAD Sterilizer

Strip Transfer

Spore Suspension

A wide range of suspensions are available for process development and validation needs. The FDA requires medical device and pharmaceutical manufacturers to challenge their products by directly inoculating the device with spores to validate sterility assurance. SPSmedical spore suspensions are developed specifically for direct inoculation of products, and for the preparation of biological indicators. Suspensions come in 10 ml vials and are available in the following concentrations with a 18 month shelf-life, when stored as directed. All concentrations are per ml and contain 20% ethanol.

The products listed below are a representative of those most often ordered by our customers, others may be available. Please contact us if the required organism or concentration is not listed below.

Cat. No.	Description	UOM
BSV-105	G. stearothermophilus 10⁵ Spore Suspension	10 ml
BSV-106	G. stearothermophilus 10⁶ Spore Suspension	10 ml
BSV-107	G. stearothermophilus 10⁷ Spore Suspension	10 ml
BSV-108	G. stearothermophilus 10⁸ Spore Suspension	10 ml
BGV-105	B. atrophaeus 10⁵ Spore Suspension	10 ml
BGV-106	B. atrophaeus 10⁶ Spore Suspension	10 ml
BGV-107	B. atrophaeus 10⁷ Spore Suspension	10 ml
BGV-108	B. atrophaeus 10⁸ Spore Suspension	10 ml

Dual Species Spore Strips

Dual species strips contain both geobacillus stearothermophilus and bacillus atrophaeus spores allowing the strips to be used to test most sterilization processes including dry heat, steam, chemical vapor, and EO gas. During use, place the blue glassine envelope inside a product or product package. After processing, the BI is to be aseptically cultured in soybean casein digest medium, and incubated at the appropriate time and temperature. Soybean casein digest medium (culture media) is also available. Indicators come with a 2 year shelf-life when stored as directed. Each lot is shipped with a Certificate of Performance, which list lot specific information and any adherence to USP or ISO performance requirements.

Cat. No.	Description	UOM
DS-100	Dual Spore Strip (G. stearo. 10⁵ and B. atrophaeus 10⁶)	100/pk
DS-500	Dual Spore Strip (G. stearo. 10⁵ and B. atrophaeus 10⁶)	500/pk
DS-1000	Dual Spore Strip (G. stearo. 10⁵ and B. atrophaeus 10⁶)	1000/pk
CM-020	Culture Media	20/bx
CM-100	Culture Media	100/bx
CM-300	Culture Media	300/bx

Single Species Spore Strips

Biological indicator spore strips are available for all sterilization processes. During use, place the blue glassine envelope inside a product or product package. After processing, the BI is to be aseptically cultured in soybean casein digest medium, and incubated at the appropriate time and temperature. Soybean casein digest medium (culture media) is also available. Indicators come with a 2 year shelf-life when stored as directed. Each lot is shipped with a Certificate of Performance, which list lot specific information and any adherence to USP or ISO performance requirements.