Contract Services
- ISO 18472 Compliant Steam BIER
- GMP Compliant Laboratory
- QA reviewed reports
- Rapid turnaround times
- 75 years combined experience in Biological Indicator and Contract Testing
Third Party Biological Indicator Testing
- POP-101 Population Verification
- DVV-102 D-value verification using fraction negative method (steam and dry heat)
- SKD-103 Survival/Kill D-value verification (steam and dry heat)
- PUR-104 Purity testing (all modalities)
- MID-105 Organism identification (all modalities)
- PCO-106 Population, Purity, Organism ID (all modalities)
Inoculated Product Testing
- DSC-107 D-value analysis on liquid pharmaceutical products using survivor curve method (steam)
- ZSC-108 Z-value analysis on liquid pharmaceutical products using survivor curve method (steam)
- DBS-109 D-value analysis on customer supplied bioburden isolate using survivor curve method (steam)
- DFN-110 D-value analysis on pharmaceutical stopper/component using fraction negative method (steam, dry heat)
Custom Biological Indicators
- CUS-113 Custom Biological Indicators per protocol
Vapor Hydrogen Peroxide Testing
VPHP Biological Indicator Quality Testing
Due to the poor penetration ability of Vapor Phase Hydrogen Peroxide VPHP, poorly made Biological Indicators can cause issues for end users and create costly investigations. We offer testing solutions to help screen out poor performing or poorly made BIs.
SERVICES OFFERED:
- Quality resistance testing designed to screen out poor performing BI lots
- Scanning Electron Microscopic SEM work to get an overall picture of the quality of the BI lot for spore piling and cleanliness
- Incoming inspection. Population verification, resistance testing per agreed upon cycle parameters and SEM pictures.
Need something else done with VPHP BIs? Just ask!
VPHP Isolate Testing
Great Divide Labs Offers Environmental Isolate Testing
-VPHP Resistance Testing on a Substrate
Need to know the inherent resistance of your environmental isolate against VPHP. We can inoculate the isolate at a specific CFU onto a material of choice. This can then be placed in our VPHP Resistometer for resistance testing at specified conditions. A D-value can then be calculated off of the fraction negative results gathered.
Other
Need something else done with your environmental isolate, just ask!