HIGUCHI INC. Product Lineup

EVA-based high-frequency welded tubes and connectors ensure the integrity of a completely sealed system once filling is complete. This process is already used in Technoflex's sterilization bags, preventing the risk of contamination and issues related to the transfer between the container and its contents, while also controlling the assembly costs of the fillers. EVA bags manufactured in an ISO 8 cleanroom undergo numerous tests in accordance with good manufacturing practices, including endotoxin level assessments and airtightness tests. The capacity of the bags ranges from 5 to 500 ml. Sterilization using beta or gamma rays is also available upon request. Technoflex provides global "all-in-one" sterilization for bags, tubes, and connectors.

The products are manufactured in a controlled environment compliant with ISO 7 by specially trained personnel. Some of the products adhere to strict quality control protocols, including particle count, microscopic observation, and individual bag pressure tests.

We assemble various single-use parts such as tubes, bags, filters, filling needles, and RTP ports according to your requirements. After assembly, they can be sterilized and delivered. The parts undergo various tests and validations based on guidelines.

In the pharmaceutical industry, sterility is one of the most important factors in ensuring product quality and safety. Particularly in the vial filling process, it is essential to minimize the risk of contamination. Filling lines that comply with PUPSIT (Pre-use Post-sterilization integrity testing) are a crucial solution for ensuring sterility. Our filling lines confirm integrity before filling and maintain a sterile state by adhering to PUPSIT. 【Usage Scenarios】 - Vial filling process - Manufacturing of sterile preparations - Adoption of single-use systems 【Benefits of Implementation】 - Assurance of sterility - Reduction of contamination risks - Improvement of product quality