Advanced Test Concepts Inc. (ATC; Indianapolis) has developed advanced methods for testing container/closure integrity using mass extraction technology. The company markets the Intelligent Gas Leak Sensor (IGLS) to detect defects down to 2 microns in dry-goods packaging such as bottles, blister packs, and sterile trays; it offers the Intelligent Molecular Flow Sensor (IMFS) for detecting submicron defects in liquid-goods packaging such as sterile parenteral glass vials and syringes for injectable drugs.
Through its OnSite packaging engineering service, Oliver-Tolas Healthcare Packaging (Grand Rapids, MI) has been able to learn a lot about how converted products fare during package testing. Originally launched to support medical device manufacturers with packaging protocols and validation as well as regulatory and standards education, OnSite has given Oliver-Tolas engineers testing feedback to inform the company’s own product development.
Mocon Inc. has established multiple in-house package testing laboratories (in United States, Germany, China, and India) that allow companies to try out instrumentation before buying it. Capabilities include headspace, water vapor, leak rate and hole size determination, burst, creep, seal strength, heal sealing, hot-tack, coefficient of friction, vacuum decay, and shelf-life analysis.
Witnessing a growing demand for testing precision and data collection and analysis capabilities, T.M. Electronics has developed the BT Integra-Pack Package Tester. The Integra-Pack is compliant with ASTM F2095, F1140, and F2054; ISO 11607; and the requirements of 21 CFR Part 11, reports the company. It will be on display in Booth 1588 at the upcoming MD&M West 2010 beginning February 9 in Anaheim.
Customers who want to witness first hand the effectiveness of X-ray technology can submit product samples for testing and receive an instantaneous analysis from Eriez (Erie, PA). Testing is undertaken at Eriez’ Technical Center in Erie where application tests numbering in the tens of thousands on all types of materials and processes have been conducted since 1964.
Service Industries (Rolling Meadows, IL) is distributing the Sepha BlisterScan and Sepha PakScan testers from Sepha LTD (Belfast, IR). For non-destructive leak testing of finished blisters, Sepha BlisterScan laser-scans the blisters to detect displacement of the blister cavity profile after a vacuum is introduced into the chamber.
The Institute of Environmental Sciences and Technology (IEST; Arlington Heights, IL) has published a new Recommended Practice (RP) for the selection of flexible packaging materials for use in contamination-critical applications. The RP includes references to FDA, ISO, and other pharmaceutical and medical device packaging standards.
The need to test for minute levels of gases and vapors in pharmaceutical, biopharmaceutical, and nutraceutical packages is growing, reports Anthony Ahmed, product manager for Mocon Inc. (Minneapolis). “With the advancements in genetics, live medicines with living organisms are now more prevalent,” he explains. “The products have low tolerances for atmospheric influence.”