Frequently Asked Questions - Quality Control and Assurance

How does SurModics ensure lot-to-lot consistency with the production of its Stabilization Products?

All SurModics Stabilization Products are manufactured per ISO 9001 & 13485 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 and the StabilZyme AP and HRP Conjugate Stabilizers, and StabilZyme SELECT Stabilizer contain less than 10 grams per liter of 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.

For a copy of our BSA Certificate of Origin, click HERE.

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