Purple Diamond, a packaging engineering and testing leader, offers ISO 11607 medical device packaging validation services. These comprehensive services ensure the safety and sterility of medical devices throughout their lifecycle, supporting manufacturers in achieving regulatory compliance and safeguarding patient outcomes.

ISO 11607 is the international standard for medical device packaging validation, encompassing requirements for materials, sterile barrier systems, and sealing processes. Recognized by the FDA, this standard provides a framework for designing and validating packaging systems that maintain sterility and usability from manufacturing to point-of-use. Purple Diamond’s state-of-the-art facilities and expert team deliver tailored solutions to meet these stringent requirements.

“Our ISO 11607 validation services empower manufacturers with confidence in the safety and reliability of their medical device packaging,” says Bill Colaiaco, President of Purple Diamond. “By adhering to the highest standards of sterility and functionality, we help our clients protect their products and the patients who rely on them.”

Purple Diamond’s ISO 11607 services include package integrity testing, accelerated aging, peel and seal strength testing, and container closure integrity testing.

With a focus on precision and innovation, Purple Diamond’s ISO 11607 validation services help medical device manufacturers achieve regulatory compliance, enhanced product safety, and cost-effectiveness.

To learn more about Purple Diamond’s ISO 11607 packaging validation services or to schedule a consultation, visit https://purple-diamond.com/iso-11607-packaging-validation/.

About Purple Diamond: Purple Diamond specializes in packaging engineering, design, and testing solutions for the pharmaceutical, medical device, cosmetics, and consumer products industries. With a commitment to innovation, the company offers cutting-edge services designed to help businesses ensure product safety, regulatory compliance, and efficient distribution, meeting ISTA, ASTM, ISO, and TAPPI Standards. Services include packaging design consulting, prototype development, package integrity testing, and stability storage testing. To learn more, visit https://purple-diamond.com/.