Testing & Inspection Articles of Note

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An executive specializing in international regulatory affairs assesses the current movement toward globalization and identifies key areas requiring the most urgent action. Fred S. Halverson (vice president of international regulatory strategy and reimbursement policy at Medtronic Inc.) writes, "The environment is right for efforts between government and industry to produce real progress in these areas. If this comes to pass, both patients and the enterprise of medical research will surely benefit." A thought-provoking discussion reveals five areas where Halverson believes global harmonization efforts should be focused.

A comparison of the GHTF Guideline and FDA practices reveals the agency is in compliance with most requirements. Timothy Wells analyzes the sections of the Guideline with special emphasis on sections 5-8. He examines general principles for auditing organizations (section 5), audit objectives (section 6), audit scope (section 7), and types of audit (section 8), and demonstrates the intrinsic similarities between FDA policies and the GHTF Guideline. A detailed bibliography provides additional areas for further investigation.

Fifteen to twenty years ago, machine vision systems were regarded as futuristic, and they were expensive and rare. Now, costs are much more reasonable, and it is rare to walk into a pharmaceutical packaging or labeling facility without seeing such a system. This article discusses the current state of vision systems, as well as their seemingly endless potential for future applications.

There is almost no limit to what medical device manufacturers will do to their packages. They will rip them apart, blow them up, fry them, freeze them, and even sniff them. Review the latest methods for testing packaging, including peel, tensile, burst, leak, force decay, helium leak, vacuum, bubble, ultrasonic, thermal, and shock and vibration tests.

Using an automated inspection system, a pharmaceutical printer works toward 100% defect-free labels. By working with Focus Automation Systems Inc. (Waterloo, ON, Canada), a provider of high-speed automated inspection systems, Keller Crescent Co. (Evansville, IN) was able to boost speed and accuracy over human inspection standards.

A review of multifunction testing instruments, including helium leak, bottle-cap torque, and self-teaching leak testers. Detailed information on each tester along with contact information is provided here.

Another review of testing instruments is available here. Among the products feature include a handheld calibrator, a leak/flow calibrator, a process verification test and analysis system, stent testers, and an automatic porosity and smoothness tester. As with the above article, detailed product and contact information are presented.

Sensors designed to aid in process control of testing and inspection equipment come in variety of specifications and sizes. A review of various such products, ranging from a tiny diffuse laser sensor to compact luminescence detectors and a flow-through pressure transducer are discussed in this article. Detailed product and contact information is included.

Another review of testing equipment, with contact and product information.