Media
Press Release 04-09-09
Don’t Miss PTI Inspection Systems at the PDA Annual Meeting in Booth T-26
Tuckahoe, New York (March 9, 2009) - PTI Inspection Systems will exhibit at the PDA Annual Meeting, April 20-21, 2009 at the Red Rock Resort in Las Vegas, Nevada in Booth T-26. PTI will present the latest developments concerning the VeriPac 325/LV vacuum decay micro leak tester for empty syringes, liquid-filled syringes, liquid filled & lyophilized vials, as well as other types of liquid filled packaging.
Heinz Wolf, general manager of PTI Inspection Systems, stated, "A case study that compares the dye ingress test with vacuum decay technology was conducted in 2008. The results of this study are remarkable, and are of tremendous value to the pharmaceutical industry, especially in the field of container closure integrity for syringes, vials, and ampoules. The VeriPac 325/LV vacuum decay method was found to be more sensitive, more reliable and provides quantitative results that are not subject to human interpretation. Vacuum decay detected all defects ≥ 5.0 μm with no false positives and no false negative results."
"We are also very pleased about the recent release of the new ASTM Test Method F2338-09" added Wolf. "Specifically referenced in this test method addendum are liquid filled package applications (with or without gas headspace), including glass syringes, ophthalmic dropper bottles, glass or plastic vials with elastomeric closures. This new test method puts the VeriPac 325/LV at the forefront of pharmaceutical laboratory equipment. The instrument's 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."
The VeriPac 325/LV is capable of detecting the slightest amount of vapor and gas release 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).
Wolf was invited to speak at the recent PDA Dinner Meeting on March 12th in Boston, Massachusetts. "My presentation focused on the leading non-destructive inspection technologies for package integrity testing and CCIT," said Wolf. "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. Destructive test methods without a data stream are being replaced more and more by systems that conform to uniform standards, such as the ASTM."
Wolf concluded, "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 such as the dye ingress vs. vacuum decay have proven that 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."
About PTI Inspection Systems
PTI Inspection Systems is the leading manufacturer of non-destructive package inspection technologies for the pharmaceutical, medical device, food and container industries. We offer inspection systems for package integrity testing, seal integrity and leak testing. Our technologies exclude subjectivity from package testing, and use test methods that conform to ASTM standards. PTI Inspection systems provide repeatable, reliable results and can be incorporated into protocols at any point in the manufacturing process as they are non-destructive, non-invasive and require no sample preparation.
For media inquiries, please contact Michelle Wolf: m.wolf@ptiusa.com. Tel: 973.252.6039
For corporate inquiries, please contact Heinz Wolf: h.wolf@ptiusa.com. Tel: 914.337.2005
