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NDT.net Issue - 2009-04 - NEWS

PTI Will Showcase Micro Leak Tester for Pharmaceutical Packaging at Interphex in Booth 236


PTI – Packaging Technologies & Inspection4, Tuckahoe, NY [USA]
NEWS  
NDT.net Journal
Issue: 2009-04
Announcing New ASTM Test Method F2338-09 for Syringes & Liquid Filled Packaging

Tuckahoe, New York (March 9, 2009) - PTI Inspection Systems will showcase the VeriPac 325/LV micro leak tester at the Interphex Show on March 17-19, 2009 at the Jacob Javits Convention Center, New York, NY in Booth 236.

VeriPac 325LVThe VeriPac 325/LV non-destructive inspection system offers unique integrity testing approaches, permitting highly sensitive micro leak detection of empty syringes, liquid-filled syringes and liquid filled & lyophilized vials, as well as other types of liquid filled packaging.

Heinz Wolf, general manager of PTI Inspection Systems, stated, "We are very pleased about the recent release of the new ASTM Test Method F2338-09 which includes liquid filled containers.   This new test method puts the VeriPac 325/LV at the forefront of pharmaceutical laboratory equipment.   The VeriPac 325/LV core technology is based on the ASTM vacuum decay leak test method (F2338) recognized by the FDA as a consensus standard for package integrity testing. This test method was developed using VeriPac leak test instruments, and this new addendum was based on tests using the VeriPac 325/LV."

vial & syringeThe new addendum to the ASTM F2338-09 "Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method" now includes leak testing liquid filled package applications (with or without gas headspace).   Specifically referenced in the test method are the following types of packaging containing liquid materials:

• Glass syringes
• Ophthalmic dropper bottles
• Glass or plastic vials with elastomeric closures
• Lidded nonporous trays and cups
• Flexible packages such as pouches and bags

The VeriPac 325/LV is capable of detecting the slightest amount of vapor and gas release as little as 0.1 microliters and can be incorporated into protocols at any point in the handling process since it is non-destructive, non-invasive and requires no sample preparation. Applications for this technology include stability studies, clinical studies, quality assurance testing and production statistical process control (SPC).

The VeriPac 325/LV is capable of detecting the slightest amount of vapor and gas release as little as 0.1 microliters and can be incorporated into protocols at any point in the handling process since VeriPac 325LV-Bulk Pharmaceutical Chemical chamberit is non-destructive, non-invasive and requires no sample preparation. Applications for this technology include stability studies, clinical studies, quality assurance testing and production statistical process control (SPC).

"VeriPac instruments have proven to be the ultimate front-to-back leak testing solution for the pharmaceutical industry," added Wolf. "Using non-destructive vacuum decay leak testing technology, test chambers are designed to accommodate the full range of container and package types used in pharmaceuticals including Bulk Pharmaceutical Chemical (BPC) and  Active Pharmaceutical Ingredient (API) containers and bags as well as unit dose bottles, cups, vials, ampoules and blister packs. Test components are optimized according to the type of package being tested and the level of sensitivity required. This versatility offers a tremendous advantage to companies looking for a reliable VeriPac 325LV-Bulk Pharmaceutical Chemical testingall around leak testing solution that can be implemented at various stages of the drug manufacturing process, starting at the bulk level.    Since testing is non-destructive, it allows for increased sampling and offers fast, precise and repeatable test results."

Tony Stauffer, president of PTI concluded, "Destructive test methods without a data stream are being replaced more and more by systems that conform to a uniform standard, such as ASTM. The focus and goal of PTI's inspection technologies is to exclude subjectivity from package testing, as well as maintain the integrity of the package so it can enter the market or be used for further testing. Case studies have proven that vacuum decay technology is superior and more reliable than dye ingress tests for example. Subjective testing using destructive test methods can be costly by providing misleading results and results that vary from operator to operator, which further complicates the inspection and validation processes. The pharmaceutical industry as a whole has recognized the demand for better, faster inspection methods that over time cost less because less waste is produced."


About PTI Inspection Systems

PTI Inspection Systems is a leading manufacturer of non-destructive inspection technologies for the pharmaceutical, medical device, food and container industries. Recognized as a thought leader in new delivery systems for seal, package and container integrity testing, PTI has set the standard for inspection systems that provide repeatable, reliable results. Having a PTI inspection solution in place for QA/QC process control guarantees that your package is "fit for purpose" from manufacturing through distribution.

For corporate inquiries, please contact Oliver Stauffer: o.stauffer@ptiusa.com. Tel: 914.337.2005

More of PTI – Packaging Technologies & Inspection published in NDT.net
2010-11-01: PTI will Showcase the Seal-Sensor™ 510 Ultrasound Inspection System at Pack Expo International 2010 in McCormick Place, Chicago, IL
2009-08-01: PTI Exhibits Inspection Solutions for Plastic Bottle & Containers at NPE in Chicago
2009-04-01: PTI President Speaks at National Seafood Conference


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