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オムピジャパン

addressAichi/Naka-ku, Nagoya-shi/Aoi 3-21-13, Clarity Building 3rd Floor
phone052-856-0181
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last updated:Mar 26, 2019
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Extracts and Leachables Testing (E&L)

Acting as one of the Japan windows! Packaging materials other than Ompi products can also be contracted through our company!

Nelson Labs (formerly Toxikon Europe) is a global CRO with approximately 20 years of experience in the E&L testing business. It has received high praise for its extensive experience and knowledge, as well as its high identification rates and toxicity assessments supported by one of the industry's largest compound databases. The company supports hundreds of application data submissions to the FDA and EMA each year and provides information through various regulatory requirements and analytical technology training and seminars to pharmaceutical companies and container manufacturers worldwide. As interest in E&L testing grows in Japan, Ompi Japan is active as one of the company's points of contact in Japan. We can also accept contracts for packaging materials other than Ompi products through our services. **Features** - Providing Extractable & Leachable services for approximately 20 years (continuing from the Toxikon Europe era) - State-of-the-art analytical facilities suitable for Extractable & Leachable testing - Extensive experience and knowledge in container closure systems suitable for biopharmaceuticals and low molecular weight formulations *For more details, please refer to the related links or feel free to contact us.*

  • Other Testing Contract

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Plastic solutions

We provide plastic solutions to the healthcare industry by leveraging our unique technologies and know-how.

Our company offers pharmaceutical, diagnostic, and medical custom plastic solutions from Balda, a leading company in medical plastic CDMO. We support our customers by integrating various development processes, from concept development to design, manufacturing, and global supply. With a modular approach, we respond to our customers' needs and requests at various project stages. 【Features】 ■ High-precision injection molding technology ■ Comprehensive solutions covering fully automated assembly processes ■ Product design and development through close dialogue with customers (CDMO) ■ Enhanced customer support and project management ■ Advanced tool design, repair, and maintenance, etc. *For more details, please download the PDF or feel free to contact us.

  • Plastic containers

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Vial & Cartridge "EZ-fill(R)"

We offer a wide range of glass pharmaceutical containers that can be filled.

"EZ-fill(R)" is a glass pharmaceutical container that is cleaned, depyrogenated, and sterilized, ready for immediate filling. The nest tab and tray have a double structure, providing syringes, vials, and cartridges with the nest tab. We can develop customized products according to customer needs, making it suitable for both small batch and large-scale production. [Features] ■ Improved flexibility ■ Minimization of total ownership costs ■ Enhanced quality ■ Reduced time to market *For more details, please download the PDF or feel free to contact us.

  • Glass container

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Analytical Solutions

We provide analytical services at our headquarters laboratory in Italy, accredited by Accredia in accordance with ISO/IEC 17025:2018.

Our company handles the analytical testing services of SG Lab, an analytical chemistry research institute that is part of our group's service division, specializing in chemical analysis, material property evaluation, and physical/mechanical performance evaluation. With a wide range of expertise in research projects and scientific analysis of primary packaging, as well as the know-how of our skilled team, we strive to help our customers understand the potential interactions between pharmaceuticals and containers. 【Services Offered】 ■ Chemical Analysis ■ Material Identification Evaluation ■ Container Performance Analysis ■ Container Interactions ■ Analytical Services Tailored to Customer Needs ■ Consulting *For more details, please download the PDF or feel free to contact us.

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Syringe "EZ-fill(R)"

Glass pharmaceutical containers that are cleaned, sterilized, and ready for immediate filling.

"EZ-fill(R)" is a glass pharmaceutical container that is cleaned, depyrogenated, and sterilized, allowing for immediate filling. By using this product, the capital investment required for traditional bulk syringes is reduced. The manufacturing process (product acquisition, maintenance, etc.) is also simplified, enabling significant cost reductions. 【Lineup】 ■Ompi Fina ■Ompi Nexa *For more details, please download the PDF or contact us.

  • Glass container

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