Packaging
PTI Introduces New Inspection Method for Empty & Pre-Filled Syringes
Friday 02. May 2008 - Interpack Show, April 24-30, 2008 in Düsseldorf, Germany, PTI Inspection Systems will showcase a new non-destructive micro leak tester for empty & pre-filled syringes and liquid filled & lyophilized vials at the Interpack Show, April 24-30, 2008 in Düsseldorf, Germany, Hall 12/Booth C13-03.
“Pre-filled syringes are one of the most critical ready-to-use products used in the pharmaceutical industry today”, stated Heinz Wolf, general manager of PTI Inspection Systems. “In response to the popularity and demand for this product, PTI has developed a new non-destructive test method that offers unique integrity testing approaches, permitting highly sensitive micro leak detection of empty syringes, liquid-filled syringes and liquid filled & lyophilized vials. The VeriPac 325/LV was presented and demonstrated to the FDA on March 12 and was very well received. This test method puts the VeriPac 325/LV at the forefront of pharmaceutical laboratory equipment.”
Leak testing pre-filled syringes is a challenge since there is minimal headspace which prevents vacuum decay alone from detecting the micro leaks, and testing both closures at once requires a different approach. Testing these types of products demands the same level of sensitivity required for any injectible drug and requires the highest level of repeatability and accuracy.
Wolf added, “The VeriPac 325/LV is up to the task, detecting the slightest amount of vapor and gas release as little as 0.1 microliters. This technology is of tremendous value in the field of
pharmaceutical package integrity testing. This latest addition to our product line will allow the
industry to predict and prevent package failures and assure marketed product safety.”
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. A comprehensive IQ, OQ, PQ validation qualification package is also available.