Contract Studies Laboratory: Biological Indicator Testing
Mesa Labs offers Steam and EO D-value or Survival/Kill testing in state-of-the-art BIER Vessels. D-value procedures used follow USP/ISO and can be obtained via Spearman Karber (fraction negative) method, Survivor Curve (direct enumeration) or with Stumbo-Murphy-Cochran. Mesa Labs can inoculate and perform D-value analysis on small items (e.g. coupons or stoppers) or we can verify a competitor’s claim for D-value, z-value, and population.
- Label Claim Testing
- Product Development
- Certificate of Analysis Verification
- BI Culturing
- Population Determination
- Identification/Purity Testing
- D-value Testing (Steam, EO, Dry Heat, H2O2
- z-value Testing
- Survival Kill Verification
- Ampoule Filling for Self-Contained BIs
- BI Development for Novel Sterilization Process
- Inoculation of Client Provided Substrate
- Population and Resistance Characterization
- Environmental Isolate Growth and Characterization Testing
- Contract Batch Production (spore forming non-pathogenic bacteria)
- DEA Certificate for testing on narcotics, stimulants and depressants (Schedules 2, 2N, 3, 3N, 4, 5)
Exposure and culturing studies are typically performed on chemical and biological indicators for Ethylene Oxide, Dry Heat, Steam, and Hydrogen Peroxide Vapor. The product in test is exposed, cultured, and the results are recorded according to protocol.
Our testing laboratory will gladly work with you to develop a testing program tailored specifically to the needs of your company. To inquire about our service capabilities and pricing, please contact us.
D-value procedures used follow USP/ISO and can be obtained via Spearman Karber (fraction negative) method, Survivor Curve (direct enumeration) or with Stumbo-Murphy-Cochran.