Life Technologies

7 Delivering quality in every bottle For over 50 years, Gibco ® cell culture products have set the global standard for quality and performance.* As the world's leading supplier of sera, we add value to each product through all stages of collection, processing, filtration, testing, and delivery, using stringent process controls and the highest quality standards. Processed lots of Gibco ® fetal bovine serum (FBS) are: • Never blended with FBS from other countries or origins • Manufactured in the country of origin, where applicable, to ensure product integrity and to avoid the risk of cross-contamination • Processed and tested according to cGMP requirements We maintain rigorous control of every step in the production of Gibco ® FBS and other sera. Complete vertical integration, from collection to final product, minimizes the risk of contamination with adventitious agents, improves lot-to-lot consistency, and results in superior performance. We manufacture in compliance with the Food and Drug Administration's (FDA's) Quality System Regulation (cGMP) at our ISO 13485 facility in the US and our ISO 9001 facilities in Australia and New Zealand. Comprehensive documentation provides traceability and control of our processes. Also, Gibco ® sera have recently undergone a rigorous process to obtain International Serum Industry Association (ISIA) traceability certification (Figure 1). This certification provides you with peace of mind and the confidence that Gibco ® sera are manufactured under the highest traceability standards, offering quality and performance for your research. What does traceability certification mean? • We maintain records of traceability from origin throughout the supply chain for all serum batches • We maintain the history for both quality and quantity of material, from point of collection through final processing • We retain documentation to support all stages of processing, transportation, and commercial transactions Using aseptic cardiac puncture procedures, we collect fetal bovine blood in single-use bags specifically designed to improve clotting efficiency and serum yield. We then quickly refrigerate the raw material, separating, evaluating, and filtering it according to our stringent specifications. A typical FBS batch size is 1,000–1,600 L; some sources permit batch sizes up to 2,000 L, depending on the manufacturing site. Following final filtration (to triple 0.1 micron), which removes bacteria without removing critical serum components, we aseptically dispense the serum into sterile bottles. We then label and freeze the final product and place it on quarantined status until all quality control tests have been completed. Our process engineering department fully validates procedures and processes to ensure quality and reproducibility. Our quality systems department can trace the raw serum back to the donor farm or abattoir where it was collected. Only serum that meets all of our particular manufacturing and finished-product specifications is approved for sale. Serum collection and processing methods can affect the quality of the final product Figure 1. Effective February 12, 2014, our sera products are ISIA Traceability Certified.

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