JANESVILLE, WI—January 27, 2016—Medical device manufacturers understand the vital need to only work with packaging suppliers who can meet their strictest quality requirements with complete traceability. That’s why the world’s largest OEMs have come to rely on Prent Corporation’s comprehensive Quality Assurance procedures to prove their packages meet those requirements.
“Our quality system follows a Plan-Do-Check-Act methodology to coordinate continuous improvement,” explains Dave Henry, Prent Vice President of Quality. “It all begins with understanding customer requirements, providing robust designs, utilizing process controls to provide defect free products—and verifying the outputs at various toll gates throughout the process.”
Prent is a leader in conducting stringent and complex process validation, utilizing process capability studies, Cpk/Ppk indexes such as 1.33 for variable data and attribute evaluations to prove critical functional dimensions.
Some of the computerized tools we use to certify that all parts are manufactured to exact, agreed-upon specifications for uniformity and tolerance include Magna Mikes and CMM (coordinate measuring machine) with vision and touch probe capability. This equipment automatically feeds and stores critical dimensions directly in our Infinity QS quality software to verify and evaluate production.
We also offer customers a complete range of value-added statistical data measurements to satisfy regulatory requirements; from a 30-piece process capability study to a rigorous IQ, OQ, PQ process validation to ensure traceability and repeatability.
For more information, contact Jim O’Dierno, Prent Executive Vice President of Sales, at sales@prent.com.
About Prent Corporation
Prent Corporation is the world’s leading designer and producer of custom thermoformed packages for the medical device industry. Headquartered in Janesville, WI, USA—and the winner of 16 WorldStar medical packaging awards—it operates nine Class 8 Clean Room facilities in China, Malaysia, Puerto Rico, Costa Rica, Denmark, Arizona and Wisconsin.
Prent Corporation World Headquarters
2225 Kennedy Rd., POB 471
Janesville, WI, USA 53547-0471
1-608-754-0276
www.prent.com
Media Contact
Vicki Damron, Marketing Director, Prent Corporation, vdamron@prent.com.