<Strengths of Otsuka Techno>
-Multilayer co-extruded film manufacturing using a water-cooled blown-film process
-Co-extrusion capabilities for customized multilayer film structures, including 7-resin/7-layer and 5-resin/5-layer configurations
-Manufacturing in an ISO Class 7 cleanroom
-Quality control in accordance with the Japanese Pharmacopoeia
-Small-batch trial production for development projects
-Customized multilayer structure design using olefin-based and functional resins to meet customer requirements
<Materials and Structures>
We design multilayer film structures using resins such as PE, PP, EVOH, cyclic olefins (COP/COC), PBT, and PA. By combining different resins, we tailor film properties to meet requirements for barrier performance, heat resistance, flexibility, toughness, heat sealability, and transparency.
<Regulatory Information>
To support our customers' regulatory submissions, a Type III Drug Master File (DMF) has been filed with the U.S. FDA for a three-layer co-extruded grade within our IV bag film portfolio. This grade has been tested in accordance with the following USP chapters:
-USP <661.2> Plastic Packaging Systems for Pharmaceutical Use — Passed
-USP <87> Biological Reactivity Tests, In Vitro — Passed
-USP <88> Biological Reactivity Tests, In Vivo (Class VI) — Passed
<Application Examples>
IV bags
Single-use bags
Microalgae culture bags
Powder packaging
Water bags
Films using biomass-derived materials
