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Custom Purified Water System for Medical Devices – Seamless System Integration for Consistent Quality Water

Case Study

The Project Situation

In effort to service more clients and increase market share in the medical field, a well known healthcare company wanted to create a fully integrated purified water system into their new planned system. The company’s R&D group was tasked with creating a global system that was robust enough to deliver endotoxin-free water at a high flow rate and with consistent quality, yet intuitive enough to be operated on a daily basis by numerous users. The system also needed to seamlessly integrate with another system and have remote access for fast and reliable service.

Our Operational Support

We pulled together a dedicated group of technical experts that worked closely with the healthcare company and their third party organizations, in order to develop a custom purified water system. This dedicated team spanned multiple areas of expertise from production, development, quality assurance and regulatory compliance and were able to address the project’s unique challenges.

The Customized Solution

After presenting several options, the healthcare company decided to move forward with a solution which contained a unique component, Electrodeionization (EDI). This technology would help the system to consistently produce water at the same level of quality, independent of the incoming tap water quality. Fewer consumables needed to be used as a result, which made it easier for any medical personnel to change out necessary components without having to call for assistance. For this project, we established a specific organization and ISO 13485 compliant production line for the development and production of medical devices. All products where then packed and labelled according to the manufacturer’s instructions.

Result

Following thier successful collaboration with us, the healthcare company was first to market with a system producing high-quality, bacteria- and endotoxin-free water above 10 MΩ, without using any chemicals for cleaning. As a result of the unique system design it was able to consistently produce water above international standards with outstanding performance. The company has since signed a long-term supply and quality agreement with us in order to secure consistent supply of consumables for future deliveries and mitigate interruptions with their customers. We are proud of this partnership, and is excited about the opportunity to help other companies with solutions that have a positive impact on human health.

Contact our experts today to help find a customized solution for you or learn more about our water purification products and services.