Whether it’s upstream bioprocessing or downstream, Spectrum Chemical’s bioCERTIFIED™ products are part of a comprehensive quality management system that includes APIs, excipients and other chemicals that carry additional certifications and documentation.

Backed by our “100% tested and 100% transparent” guarantee, each bioCERTIFIED™ chemical undergoes full compendial testing with additional testing for total aerobic microbial count (TAMC), total yeast and mold count (TYMC), residual solvents, elemental impurities validated to USP 232/233, and presence of endotoxins according to the specifications of the compendia or internally set limits. Products are packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA registered and inspected facilities. Key attributes of Spectrum Chemicals bioCERTIFIED™ portfolio include:

• Full monograph testing for every lot– to include TAMC, TYMC, elemental impurities and endotoxin according to the specifications of the compendia or internally set limits
• Comprehensive technical documentation– professionally-prepared files succinctly provide documentation for all bioCERTIFIED chemicals
• Extensive product breadth and availability– globally-sourced products include amino acids, biological buffers, inorganic salts, sugars, carbohydrates, cleaning-in-place solutions and more
• Scale-up and streamlined speed-to-market support– flexibility to accommodate different requirements from small, pre-packaged (pilot) to bulk sizes
• Industry-leading service– technical support, dedicated sales advisor support, regulatory, quality management and purchasing teams