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Comprehensive ISO 11608 Testing Ensures Safety, Quality, and Regulatory Compliance
The PennZone/10292684

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Purple Diamond provides comprehensive testing for needle-based injection systems in accordance with ISO 11608, ensuring safety, quality, and regulatory compliance for medical devices.

BETHLEHEM, Pa. - PennZone -- Purple Diamond, an industry leader in medical device packaging validation, offers comprehensive ISO 11608 validation services for needle-based injection systems. This critical testing ensures the safety, accuracy, and reliability of devices such as pen injectors, autoinjectors, pre-filled syringes, and on-body delivery systems.

Needle-based injection systems are indispensable for administering life-saving medications, including treatments for diabetes, arthritis, and chronic pain. ISO 11608 establishes essential design, development, and testing guidelines for precision, sterility, and patient safety.

"Our ISO 11608 validation services empower manufacturers to deliver reliable and compliant needle-based injection systems and packaging, ensuring confidence for regulators and patients," says Bill Colaiaco, president of Purple Diamond.

Purple Diamond offers a full suite of testing services to support ISO 11608 compliance, including durability under stress testing to evaluate device resilience in real-world conditions, stability testing to assess performance after exposure to environmental changes, and container closure integrity (CCIT) to verify secure barriers against leaks and contamination.

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As an ISO-accredited facility, Purple Diamond delivers tailored testing solutions backed by advanced equipment and a team of industry experts. For more information about Purple Diamond's ISO 11608 validation services or to schedule a consultation, visit https://purple-diamond.com/iso-11608/.

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/.

Contact
Keri Lindenmuth
***@purple-diamond.com


Source: Purple Diamond Testing

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