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Bacterial Endotoxin Detection In Hyaluronic Acid-Based Medical Devices, Larissa F. Baeva, Srilekha Sarkar Das, Victoria M. Hitchins
Bacterial Endotoxin Detection In Hyaluronic Acid-Based Medical Devices, Larissa F. Baeva, Srilekha Sarkar Das, Victoria M. Hitchins
Food and Drug Administration Papers
A simple and rapid method has been developed for testing bacterial endotoxin in hyaluronic acid (HA)-based medical devices. High-molecular-weight HA (HMW HA) in solution or HA-based medical devices was digested by the enzyme hyaluronidase to reduce solution viscosity by truncating the long chains of HA and to test for bacterial endotoxin. The bacterial endotoxin level was detected and measured by kinetic chromogenic Limulus Amebocyte Lysate (LAL) assay. The method was applied to two different ophthalmic viscosurgical devices (OVDs) and one dermal filler, and may easily be adapted to use with up to 3% HA solutions and other HA-based medical devices.