Protein Stabilizers / Blockers FAQ
Frequently Asked Questions about Surmodics Protein Stabilizers / Blockers
How does Surmodics ensure lot-to-lot consistency with the production of its Stabilization Products?
All Surmodics Stabilization Products are manufactured per ISO 13485 and 9001 standards under stringent controls to ensure lot-to-lot consistency and complete lot traceability. The raw material components of each lot are proprietary; however, be assured that each component is fully qualified before release to the manufacturing floor. All manufacturing materials are quarantined until required testing and inspection have been performed and acceptance criteria have been met. For each lot, final quality control testing confirms that the lot meets pre-defined product specifications for proprietary components, physical characteristics, and performance.
How does Surmodics verify the origin of any bovine serum albumin (BSA) that may be used in their Stabilization Products?
StabilCoat immunoassay stabilizer, StabilZyme AP and HRP conjugate stabilizers, and StabilZyme SELECT stabilizer contain a bovine-derived serum protein. Our suppliers of this component certify that the bovine plasma from which it was purified was collected entirely from domestic animals in abattoirs regulated by the United States Department of Agriculture. All abattoirs are located in the United States. Furthermore, the animals from which the plasma was derived received ante-mortem and post-mortem inspection at the time of slaughter and appeared to be free from infectious and contagious diseases and injurious parasites. The United States Department of Agriculture considers the United States to be free from Bovine Spongiform Encephalopathy (BSE). These products do not contain and are not derived from any Specified Risk Materials as defined as the following: the skull, including the brain, eyes, tonsils and spinal cord of: bovine animals aged over 12 months, or ovine and caprine animals which are aged over 12 months or have permanent incisor tooth erupted through the gum.
What are the shelf life and storage recommendations for the Stabilization Products?
The optimal storage temperature for the Stabilization Products is 2-8°C; however, storage at room temperature will not affect product performance.
Please note that the Stabilization Products are shipped to customers at ambient temperature. However, extensive stability studies have been performed to show that prolonged storage at ambient temperature will not affect the product quality or efficacy.
How can I get a product approved without knowing what's in it?
- All of our products are manufactured according to QSR guidelines, under ISO 9001 and 13485
- Certificates of Conformance are provided to confirm that the products meet all specifications prior to being released for sale
- Material Safety Data Sheets (MSDS) are available for all of the products
- All of the products are proven, critical components of several commercially available diagnostic devices
Is there a preservative in the Stabilization Products?
No preservatives are added to StabilCoat & 5X StabilCoat Stabilizers or to StabilGuard Stabilizer. If you would like to add a preservative to either of these products, we recommend using ProClin® preservative at the manufacturer's recommended use concentration. ProClin is a registered trademark of Rohm and Haas Company.
However, a mercury- and azide-free preservative is added to the following Stabilization Products:
- StabilCoat® Plus Microarray Stabilizer
- StabilGuard® Choice Microarray Stabilizer (BSA-Free)
- StabilZyme® AP Conjugate Stabilizer
- StabilZyme® Protein-Free AP Stabilizer
- StabilZyme® HRP Conjugate Stabilizer
- StabilZyme SELECT® Stabilizer
- StabilZyme® NOBLE Stabilizer (BSA-Free)
- StabilZyme® Protein-Free Stabilizer