What is required for containers used for filling pharmaceutical materials?

This introduces the requirements for transporting pharmaceutical intermediates using container bags and other methods.

Container bags are commonly referred to as "frecon," but officially, they are called flexible intermediate bulk containers or FIBCs (FLEXIBLE INTERMEDIATE BULK CONTAINERS). What are the requirements for transporting pharmaceutical intermediate raw materials using container bags and similar methods? This document outlines the response of Naikai Corporation, which delivers pharmaceutical chemical products and optical resins in high-quality packaging, to the use of containers for pharmaceutical materials. It introduces methods and measures for confirming the presence of organic substances that may affect biological reactions and environmental substances that could influence genetic reactions. [Examples of Responses (Excerpt)] ■ Limitations on raw resin and additives for outer bags ■ Visible foreign substances generated during the manufacturing process of outer bags are thoroughly removed during the inspection process ■ Conduct leaching tests on inner bag materials at inspection agencies in Japan ■ Prevent secondary adhesion of foreign substances during inspections by wearing anti-static coveralls, masks, goggles, etc. *For more details, please refer to the PDF document or feel free to contact us.

basic information

【Requirements】 ■ Contamination of organic substances that affect biological responses → Contamination by bacteria, hair, body hair, etc. in the external environment ■ Presence of environmental substances that may influence genetic responses → Confirmation of genetic impact substances contained in materials * Container bags are commonly referred to as "Furecon," but officially they are called Flexible Container Bags or FIBCs (FLEXIBLE INTERMEDIATE BULK CONTAINERS). * For more details, please refer to the PDF materials or feel free to contact us.