As a founding member of the International Serum Industry Association (ISIA), our commitment to quality is one of the things that sets us apart here at Central Biomedia, Inc. Our Lenexa facility is FDA-registered as a contract manufacture of in-vitro diagnostics (Class 1 Medical Devices). We’re a USDA-licensed biologics manufacturing site and an approved USDA quarantine holding facility for imported ruminant serum, and both of our facilities are USDA EU142/2011 approved. Our dedication to quality extends beyond our certifications, and into the everyday operation of our facilities, where our extensive testing, tracking, and verification procedures ensure that our products meet the high standards of our customers every time. We’re proud of our commitment to quality, and we welcome customer audits!
All of the products produced for our customers must pass a rigorous set of testing procedures, which are constantly monitored with test validations and verifications, instrument calibration, and change controls to ensure that all methods and equipment are up to industry standards. A Certificate of Analysis (COA) is created for each lot produced, and additional testing is available upon request. Our standard COA tests for:
- Bacterial Endotoxin
- Total Protein
- Sterility (when applicable)
We can also coordinate for additional testing from outside laboratories.
All our testing and product records are documented in accordance with current Good Manufacturing Practices (cGMP). At CBI, our goal is continual improvement, and so we’re constantly looking for new and better ways to ensure the highest quality of our products and processes. We know that good recordkeeping and traceability are vital to the serum industry, and we hold ourselves to the very highest standards of quality and integrity through:
- Quarterly management review meetings.
- Internal audits performed on a regular basis for all procedures.
- Regular reviews and updates of all our Standard Operating Procedures & Protocols.
- Inspections of every shipment of Critical Device Components by quality personnel before the shipment is released for use.
- Two media fill validations per year of 5000 bottles each.
At CBI, we appreciate the value of quality and integrity. We’re compliant with ISO 13485:2003 and we’re happy to work hand-in-hand with our customers’ quality departments in order to ensure the best possible results.