Automation of the wet disinfection process during the production of suture threads from natural collagen, catgut

Abstract

Surgical sutures are the simplest yet most used medical devices in modern healthcare,  they are the preferred type because of its biocompatibility and ability to be resorbed. Bovine intestinal fibers are converted into catgut that serves as the starting material of absorbable surgical suture threads. The mechanical and control subsystems of industrial equipment were designed to automate disinfection of bovine intestinal fibers to increase efficiency during the wet process stage of disinfection without altering its fiber quality. A turbulent regime of the water and disinfectant mix was designed, implemented and validated, this automatic aeration system in the disinfection thank          increased the process efficiency by reducing the time used to handle a load of fibers by 50%, and the working time of the personnel involved in the process was reduced from 220 to 20 minutes. Tests on the final product showed that LAL levels comply with what is established by the American Pharmacopoeia: USP <85> Bacterial Endotoxin Test and USP <161> Medical Devices - Bacterial and Pyrogen Endotoxin Test. These results indicate that the disinfected catgut using the proposed automated system complies with all mechanical quality control tests.