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.
Highlights
Catgut sutures are manufactured from the submucosal layer of the serosal layer of the small intestine of cattle
Current protocols involved are highly manual and there are not commercially available solutions for their automatization which may result in increased reproducibility, reduced disinfectant usage, optimized time efficiency and suitable ergonomics for the operators
The purpose of this work is to automate some washes and rinses using a turbulent regime to increase the efficiency of the disinfection process (Juszkiewicz, Walczak, Mazur-Panasiuk, & Woźniakowski, 2020)
Summary
Catgut sutures are manufactured from the submucosal layer of the serosal layer of the small intestine of cattle. The use of a tank with an agitator impeller and baffles is widely used in industrial processes for the blending of miscible fluids, high viscosity blending, solid suspension or dissolution and liquid-liquid dispersion, among others (Weetman & Gigas, 2002). These mixer tanks are usually enclosed systems that may not accommodate the bundles of fibers from the intestines and will be hard to clean and maintain. We describe the proposed mechanical design of an aeration tank for disinfection, its prototyping, and implementation in the production plant of the company STC Peru in Lima, Peru
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