Quality Controls & Calibrators
Our Controls and Calibrators have many of the same qualities as Processed Serum including our 40 year manufacturing history, in-house product specifications, our flexibility to meet customer expectations, and our willingness to provide lot sizes from 100 to 100,000 vials.
Currently, two formats are available: Liquid products for user convenience which avoid reconstitution or any user errors that can occur during reconstitution; and Lyophilized products which eliminate the need for frozen storage, and are the industry standard for calibrator material due to precision and long term stability.
Controls, Calibrators, and Proficiency Testing specimens are formulated in our 250 square foot Class 1000 Clean Room, or under one of our Class 100 laminar flow hoods. The product is filled using automated pneumatic filling equipment and lyophilized in our Hull Freeze Driers.
Cone Bioproducts offers extensive in-house testing for chemistry, immunology, immunoassay, and infectious disease disciplines, and final product Quality Control procedures minimize rejection rate. Both pre-fill and final product samples are available to customers for final approval prior to release of product.
We also stock an extensive inventory of critical raw materials including glass and plastic vials, stoppers, and caps of various sizes.