Laguna Niguel, CA, February 28, 2012 – Interface Catheter Solutions’ recently announced the new Auto-i 360 balloon visual/dimensional inspection system upgrades significantly reducing cycle times. Interface completed recent Gage R&R (repeatability and reproducibility) analyses of the Auto-i 360 results show that the system is accurate, consistent and reliable for balloon inspection processes. The Auto-i 360 significantly reduces inspector-to-inspector balloon inspection variability.
The visual inspection Gage R&R results show that the Auto-i 360 is capable of tabulating and analyzing the same defect multiple times analyzed by a single trained inspection operator. This was completed with two trials and two trained technicians viewing for repeatability and agreement on the system results. The overall average agreement on repeatability was 90% (Chart A) deemed to be highly relevant within industry standards. Similar study results with trained quality inspectors and without utilizing the Auto-i 360 resulted in higher variability and reduced agreement between inspectors. The Auto-i 360 is proven to be a highly reliable inspection tool with automatically tabulated reports traceable to production lot, inspector and balloon.
Defect reproducibility was also evaluated from the ability of the Auto-i system to see the same defect from operator to operator on multiple trials. In this case the previous repeatability results were compared to determine Auto-i 360 capability. Results were also positive at 90 % (Chart A) well within expectations. The Auto-i 360 can improve manufacturer efficiency and yields saving significant cost.
“Completing the Gage R&R for our own balloon manufacturing inspection and validation process was important not only for our needs but for our customers stringent quality requirements. With these results we are confident in the system’s robust balloon inspection capabilities and effectiveness,” said Nabil Jubran, Director of Quality and Regulatory.
Dimensional capability Gage R&R also had very positive results. Inspectors and operators input dimensional criteria into the system, including center, left and right body diameter; left and right stem diameter and cone length; and body length. Dimensional results were measured against Interface balloon tolerance inspection criteria which are highly stringent in evaluating balloon quality. The results were above industry standard in all measurement criteria at ≤ 20% (Chart B).
“The Auto-i 360 has been developed with customer participation including our own production and quality engineering staff to create a highly-effective inspection tool with specification criteria based on years of balloon inspection experience,” said David Yanes, Director of Equipment. “The Gage R&R results confirm the system’s efficacy and its ability to operate successfully within tight tolerance inspection standards. The Auto-i 360 significantly decreases inspection time reducing cost and improving yields.”
The new Auto-i 360 balloon inspection system is the only system that provides both visual/flaw and dimensional measurements of medical balloons in a single operation, tested and proven in one of the largest balloon contract manufacturing facilities in the world. This Gage R&R data shows significant increases in consistency, accountability, and quality in the inspection process. Inspection includes classification and size of defects with pass/fail analysis based on user-selected criteria. The balloon inspection system operates with a sophisticated vision system and analysis program with an intuitive user interface. The Interface inspection system provides immediate detailed visual and data reporting used in both quality manufacturing inspection and research and development.
About Interface Catheter Solutions
Interface Catheter Solutions is the only vertically integrated provider of outsourced solutions for balloon and catheter manufacturing. Interface has been solely focused on the balloon catheter market since 1995 and continually sets industry standards through process and equipment advancements in balloon catheter manufacturing.
Interface has created more than 2,100 balloon designs, and offers balloon design and development, balloon contract manufacturing, extruded balloon tubing, custom medical extrusion, plus a comprehensive line of balloon catheter production and testing equipment. Interface is ISO 13485:2003 certified and operates multiple class 100,000 (ISO Class 8) clean rooms in three facilities. Interface’s headquarters is located at 27721 La Paz Road, Laguna Niguel, California. www.interfaceusa.com Tel 949.448.7056.
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