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

Juan A. Vega Farje, Ana González, F. Casado
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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.
用天然胶原蛋白、肠线生产缝线时湿法消毒过程的自动化
外科缝合线是现代医疗保健中最简单但最常用的医疗器械,由于其生物相容性和被吸收的能力,它们是首选的类型。牛肠纤维被转化成羊线,作为可吸收的外科缝线的起始材料。工业设备的机械和控制子系统设计用于自动消毒牛肠纤维,以提高湿法消毒阶段的效率,同时不改变其纤维质量。设计、实施并验证了水和消毒剂混合的湍流状态,该消毒系统中的自动曝气系统通过将处理纤维负载的时间减少50%来提高工艺效率,并且将参与该过程的人员的工作时间从220分钟减少到20分钟。对最终产品的测试表明LAL水平符合美国药典:USP细菌内毒素测试和USP医疗器械-细菌和热原内毒素测试。这些结果表明,采用该自动化系统消毒的羊肠符合所有机械质量控制测试。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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