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  Paper Details                 Browse papers by sector
Seal Integrity in Medical Device and Pharmaceutical Packages
Author            :Tony Stauffer
Designation    :President and CEO
Company        : PTI – Packaging Technologies & Inspection, LLC
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Biography

Tony Stauffer, President & CEO of PTI (Packaging Technologies & Inspection), has over 20 years of experience in Leak Detection for the Pharmaceutical, Medical Device and Food Packaging Industries. He leads his team of engineers to develop and manufacture innovative, breakthrough and emerging inspection technologies focusing on precision and accuracy, as well as simplifying the testing and validation process.

Tony Stauffer and Mikhail Kneller, PhD, have researched and developed the non-contact Airborne Ultrasonic Inspection Technology for the past five years. A recent success is the AWARD WINNING SEAL-SCAN™ technology, based on non-contact Airborne Ultrasound, researched and developed over many years by Tony Stauffer and Mikhail Kneller, PhD, and his research team.

The AWARD WINNING SEAL-SCAN™ technology, developed by PTI using Non-contact Airborne Ultrasound, has proven to be a highly effective, reliable and cost reducing method in the seal inspection of flexible packages for both on and off-line applications. This new technology was awarded the 1st Prize in the category Process and Innovation at the IPA in Paris.

PTI has also successfully met the unique challenge of nondestructively inspecting packages made of TYVEK™ or other porous materials commonly used in medical device and pharmaceutical packaging using Vacuum Decay Technology. The recently approved ASTM F2338-04 test method Standard Test Method for Non-destructive Detection of Leaks in Packages by Vacuum Decay Method was based on PTI sponsored research studies utilizing the Pti-225 Vacuum Decay Leak Tester. This ASTM F2338-04 approval marks a new standard in the field of package integrity testing for porous materials. The PTI integrity testers are FDA 21 CFR Part 11 compliant and inspection methods are ASTM approved. (Ref. ASTM F2338-03 at www.astm.org) PTI offers comprehensive IQ/OQ/PQ validation qualification services.

Tony Stauffer is a frequent speaker at forums and seminars, sharing his company’s innovations and expertise with industry experts. Prior to PTI, Tony Stauffer has spent seven years in South America and Canada in project engineering, management and implementation of large-scale industrial projects.

MASTER OF BUSINESS ADMINISTRATION (August 1980)
American Graduate School of International Management, Glendale AZ, USA

BACHELOR OF SCIENCE – Mechanical Engineer (1971)
Ingenieurschule Biel-Bienne, Switzerland

e-mail: stauffer@ptiusa.com

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