Media
Press Release 04-16-10
PTI General Manager Will Speak at Upcoming PDA Conference in Berlin, Germany
Tuckahoe, New York (April 16, 2010) - Heinz Wolf, general manager of PTI Inspection Systems, will speak at the upcoming PDA Workshop on Alternatives to the Dye Test in Berlin, Germany, on Thursday, April 29, 2010 at 11:00 am.
This PDA workshop will give an update of current best practice of integrity and leak testing of containers used for parenterals. Starting from the traditional dye test, alternative technologies will be presented and pro’s and con’s will be discussed. Technologies presented will include vacuum decay and high voltage methods.
"I will present new data about vacuum decay and high voltage technology for package integrity testing and container closure integrity of parenteral and biopharmaceutical products," stated Wolf. "Case studies have proven that these non-destructive technologies are superior and more reliable than the dye ingress test. The pharmaceutical industry as a whole has recognized the demand for improved inspection methods that are more efficient, reliable and that over time cost less because less waste is produced. The industry also recognizes the benefits of excluding subjectivity from the testing process, which eliminates misleading results and results that vary from operator to operator. There are better, more advanced technologies available that conform to uniform standards such as the ASTM, and simplify the inspection and validation processes. My presentation will also demonstrate the importance of test result data that is repeatable."
A recent issue of the PDA Journal of Pharmaceutical Science and Technology featured two articles that further demonstrates vacuum decay’s usefulness as a non-destructive leak test method for pharmaceutical packaging:
Vacuum Decay Container/Closure Integrity Testing Technology. Part 1. ASTM F2338-09 Precision and Bias Studies
Heinz Wolf, Tony Stauffer, Shu-Chen Y. Chen, Yoojin Lee, Ronald Forster, Miron Ludzinski,
Madhav Kamat, Phillip Godorov, and Dana Morton Guazzo
PDA J Pharm Sci Technol 2009;63 472-488
http://journal.pda.org/cgi/content/abstract/63/5/472
Vacuum Decay Container/Closure Integrity Testing Technology. Part 2. Comparison to Dye Ingress Tests
Heinz Wolf, Tony Stauffer, Shu-Chen Y. Chen, Yoojin Lee, Ronald Forster, Miron Ludzinski,
Madhav Kamat, Brian Mulhall, and Dana Morton Guazzo
PDA J Pharm Sci Technol 2009;63 489-498
http://journal.pda.org/cgi/content/abstract/63/5/489
Vacuum Decay Container/Closure Integrity Testing Technology. Part 2. Comparison to Dye Ingress Tests http://www.astm.org/Standards/F2338.htm
About Heinz Wolf Heinz Wolf has focused on developing inspection technologies for the packaging industry that perform with a high degree of precision and reliability, and simplify testing and validation processes in the food, pharmaceutical, medical device and container industries. Heinz received his Bachelor of Science degree in mechanical engineering from the Ingenieurschule in Bern, Switzerland. He joined PTI in 1985 and has held the position of general manager of PTI Inspection Systems since 1997.
About PDA The Parenteral Drug Association (PDA) is a leading global provider of science, technology, regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946, the PDA relies on the technical expertise of 10,000 global members. PDA’s mission is to develop scientifically sound, practical, technical information and resources to advance science and regulation for the pharmaceutical industry. In addition to sponsoring educational conferences and training courses, the PDA publishes the PDA Journal of Pharmaceutical Science and Technology and the monthly PDA Letter. In 1997 PDA established the PDA Training and Research Institute (PDA-TRI) to manage its educational programs.
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.
Contact PTI
For media inquiries, please contact Michelle Wolf: m.wolf@ptiusa.com. Tel: 973.252.6039 or 973.479.8626.
For product inquiries, please contact Jesse Sklar: j.sklar@ptiusa.com. Tel: 914.337.2005.
PTI Inspection Systems: www.ptiusa.com
