Hydromer, Inc. has announced its expansion into manufacturing and supplying automated high-speed coating and UV curing equipment, allowing the company to offer medical device manufacturers a comprehensive, end-to-end solution by integrating its proprietary coatings with high-performance machinery. This strategic move enables manufacturers to correlate process parameters directly with performance outcomes, which supports compliance with ISO 13485 and FDA Quality System Regulations (21 CFR Part 820), crucial for maintaining quality standards and regulatory confidence in the medical device industry.
The expanded equipment platform includes several key systems. The Hydrophilic Coating Equipment delivers uniform coating application and UV curing with minimal manual intervention. The Automated High-Throughput Coating System is a modular configuration comprising load, dip coating and UV curing workstations designed to be operated by a single operator, thereby increasing production rates and reducing reliance on manual labor. Additionally, the company offers Friction Testing Equipment designed for lubricity tests with precise and repeatable measurements to support performance evaluation and quality control.
Michael Torti, CEO of Hydromer, emphasized the significance of this expansion. "Hydromer has long been focused on coating performance and manufacturing consistency," Torti stated. "By manufacturing and supplying the equipment used to apply our industry-leading hydrophilic coatings, we eliminate technical barriers and help our clients reduce time to market while maintaining the highest standards of quality and regulatory confidence."
This expansion represents a significant development in the medical device manufacturing sector, where efficiency, consistency and regulatory compliance are paramount. The ability to obtain both coating technologies and application equipment from a single source simplifies the manufacturing process and potentially accelerates product development cycles. The company's move into equipment manufacturing addresses a critical need in the industry for integrated solutions that bridge the gap between coating formulation and application technology. The original release can be viewed on www.newmediawire.com.
