The contract study laboratory at SGM Biotech, Inc. provides a variety of services to the medical and pharmaceutical industries worldwide. This dedicated laboratory is fully staffed by knowledgable, experienced scientists and is well-equipped with state-of-the-art instrumentation to tackle a diverse array of projects.
All testing is performed using traceable spore populations and certified Biological Indicator Evaluator Resistometer (BIER) vessels.
D-Value and Z-Value Studies
The contract study laboratory can perform D-Value and Z-value studies on your pharmaceutical and medical devices including liquid products, rubber stoppers and plungers, process challenge devices (PCDs), and bioburden organisms. Liquid products are tested using the survivor curve method, and dry products may be tested using either the survivor curve or fraction negative method depending on the size of the product.
Scanning electron microscope (SEM) images are also available to supplement inoculated D-value studies. These micrographs will demonstrate the physical interaction between your product and the inoculated spores. They will also demonstrate what the product surface appears like in reference to particles as small as microbial spores.
* SGM Biotech, Inc. is licensed by the Drug Enforcement Agency (DEA) to perform studies on controlled substances.
Certificate of Analysis Confirmation
We are able to provide third party confirmation of certificate of analysis claims, including:
- Population verification
- Species identification
- D-value, Z-value, and survival/kill confirmation
Sterilization Exposure and Culturing Studies
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.
Unique Services
The contract study laboratory will be happy to customize a study to accomodate your specific needs based on our capabilities. We have a proven track record of satisfying unique customer requirements over a wide range of areas such as decontamination studies, resistance testing, and device qualification. Don't hesistate to contact us.
