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New look for Corning cellgro products
Mediatech, Inc., makers of the cellgro brand, became a wholly owned subsidiary of Corning Incorporated on December 1, 2011. Mediatech has been integrated into Corning’s Life Sciences segment, and product branding has been updated to reflect this change. The product brand is now Corning cellgro, updated from cellgro. The products continue to be manufactured by Mediatech, Inc, and our core business, standard products, manufacturing processes and quality systems remain the same. As a result of the brand update you may notice changes in the design of our products and shipping labels, tamper evident seals, branded packaging materials and CoA documents. The products themselves remain unchanged. Additionally, the product label design has been updated with graphic symbols, based on global ISO and EN standards.Our Mediatech cGMP facility has highly automated manufacturing processes and strict Quality Systems that enable us to guarantee low endotoxin levels for our liquid and powdered products, and to ensure that our liquid products meet the most rigid Sterility Assurance Levels (SAL). Endotoxin levels are a “Release Specification” and not “For Information Only.”
We follow current Good Manufacturing Practices (cGMPs) prescribed by the FDA (21CFR; Part 820). This requires the formalization, validation, standardization, and documentation of all operational procedures, systems, functions, facilities, materials, and equipment. We have established Standard Operating Procedures (SOPs) for all its manufacturing and quality procedures. We regularly validate our equipment and processes to ensure that they continue to meet their specified design criteria. In addition, internal quality assurance audits are performed to verify that manufacturing and quality control functions are being properly executed.
We are in compliance with FDA Guidelines for Class I Medical Devices, and the revised FDA “Guidelines for the Manufacture of In Vitro Diagnostic Products” (January 1994) for “Sterile” labeling. Like other products labeled for IVD use, Corning cellgro products are not intended for human or animal therapeutic use.
Products are prepared by an aseptic process for which each step has been validated to ensure that all cellgro products are equal to or better than the industry’s Sterile Assurance Level (SAL) of <10-3 (i.e. demonstrates a manufacturing fill process of no more than one random contaminant per 1,000 units).
We pride ourselves on our testing requirements. In designing our Manassas facility and quality systems, we incorporated many of the principles developed by the pharmaceutical industry, including the use of WFI quality water, testing of raw materials, in-process monitoring, and extensive testing of the finished product. To verify that in-process controls have served their designed purposes, extensive tests are conducted on finished products to ensure that they meet the company’s stringent release criteria. Quality Systems obtains samples of each lot of finished product in accordance with the latest edition of the U.S. Pharmacopoeia and cGMPs. These samples are selected using a computer-generated random number program and are rigorously tested according to functional, biological, and physicochemical properties and chemical attributes.