All pharmaceutical grade polymer production is conducted in accordance with the International Pharmaceutical Excipients Council (IPEC) Good Manufacturing Practices guidance for Bulk Pharmaceutical Excipients, which are recognized and published in the United States Pharmacopeia. Polymers are produced in ISO 8 clean rooms with controlled temperature and humidity in our modern, well-equipped production and laboratory facilities in Birmingham, Alabama, USA. Both Drug and Device Master Files are maintained with the FDA.
Our commitment to quality includes a thorough analysis of each lot of polymer, and every shipment of medical grade polymer includes a Certificate of Analysis (COA). Analyses include identification by 1H-NMR and FTIR, inherent viscosity (IV), monomer ratio and residual monomer levels by 1H-NMR, residual tin (from catalyst), residual solvents, bioburden (total aerobes, spores, and anaerobes), and pyrogens (LAL). Other analyses can be provided if desired, including heavy metals, solubility and cloud point in various solvents, DSC, and other compendial tests. We also have considerable expertise in measuring molecular weights using GPC and NMR techniques.