MFDS Establishes Manual to Minimize Foreign Substance Contamination in Syringes

[Image source=Yonhap News]

[Asia Economy Reporter Kim Ji-hee] The Ministry of Food and Drug Safety announced on the 30th that it has prepared a 'Syringe Foreign Substance Reduction Manual' to help manufacturers minimize foreign substance contamination that may occur during the syringe manufacturing process and to thoroughly manage quality.

This manual was prepared to present detailed management methods to reduce syringe foreign substances, following reports of foreign substance contamination in low dead space syringes (LDS syringes) since the end of February, in collaboration with the industry to analyze the causes of contamination.

It identifies the 'Four Key Management Elements' for foreign substance control in the manufacturing process, including raw materials, workers, environment, and process, and provides guidance on 11 detailed management items. These include 'Raw Material Management' such as supplier management, incoming inspection, and raw material storage; 'Worker Management' such as workforce management and worker training; 'Environmental Management' such as manufacturing facility management, pest control, and transportation management; and 'Process Management' such as foreign substance control during the process, record management, and packaging management.

The Ministry of Food and Drug Safety stated, "We hope this guide will help manufacturers minimize foreign substance contamination in syringes," and added, "We also plan to conduct periodic monitoring of quality management."

This content was produced with the assistance of AI translation services.