Global Leaders Supplying R & D Laboratory CCI Testing Solutions to the Life Science Industry
For almost 40 years, PTI is a leading manufacturer of non-destructive, deterministic package quality testing equipment, specializing in analytical benchtop laboratory systems for high-risk packaging. At PTI we are committed to advancing sensory research, innovation and development beyond physics to accelerate technological breakthroughs in package integrity testing.
Our laboratory solutions support stability studies, SPC routine testing and production line monitoring.
PTI’s sensory technologies are fully scalable and can be easily migrated from the laboratory to an automated production environment. All technologies feature PTI ETHOS 21 CFR Part 11 Data Integrity Software solutions.
E-Scan MicroCurrent HVLD Technology for Parenteral Products – applications include pre-filled syringes, vials, ampoules, BFS. PTI revolutionized the conventional HVLD method with the new MicroCurrent technology for the integrity testing for all parenteral and biological products including low conductivity liquids such as sterile water for injection. MicroCurrent HVLD utilizes about 50% less voltage and exposes the product and environment to less than 5% of the voltage when compared to conventional HVLD solutions.
VeriPac Vacuum Decay Technology – the gold standard for package integrity testing. The VeriPac Series is available in several configurations according to package specifications and test sensitivity requirements. The ASTM Test Method F2338 – Standard Test Method for Non-destructive testing using Vacuum Decay technology – was developed using PTI VeriPac instruments. This method is also an FDA referenced standard for package integrity testing and referenced in the USP chapter <1207> guideline. Applications include parenteral products and many other flexible and rigid packaging formats.
Airborne Ultrasound – PTI’s proprietary Airborne Ultrasound technology is a non-destructive and non-invasive seal quality inspection method. It can be used for many material types such as Tyvek®, paper, foil, film, aluminum, plastic & poly. In this method, ultrasound waves are allowed to propagate through the package seal causing the reflection of sound waves. Defects are identified by measuring the variation of the reflected signal strength. Seal-Scan is an in-depth pouch seal analytical tool, used to characterize seal quality and determine optimal sealing parameters. Airborne ultrasound is an ASTM Test Method F3004 and FDA standard for seal quality inspection.
Force Decay – VeriPac Force Decay technology is specifically designed for very low headspace packaging such as transdermal patches, suture packs and contact lenses. It combines PTI’s vacuum decay technology while introducing a force-based measurement to enhance results. The VeriPac 410’s force decay technology is capable of measuring force from the surface deflection of a package during a normal vacuum based test cycle. This force measurement of the package surface allows the VeriPac 410 to identify which package is defective while also being able to leak test packages with minimal headspace.
Volumetric Imaging – is a deterministic non-destructive technology designed specifically for multi-cavity blister packs. PTI’s OptiPac utilizes volumetric imaging under vacuum with topographic imaging to detect the presence and location of leaks. Designed with One-Touch Technology to achieve a rapid test cycle requiring no changeover or sample preparation. Operators simply place the blister package on the test plate and press the START button. Within seconds, the operator sees a definitive pass/fail result, and a visual identification of blister cavity defects. OptiPac technology is unique in that it can provide rapid detection of sub-5-micron defects depending on blister cavity volume. OptiPac requires no tools for different blister formats.
Helium Technology – is a highly sensitive leak test technology for container closure integrity testing, SIMS helium leak detectors has an array of applications which ranges from package design, tooling qualification, production line setup and on-going product quality monitoring. It is also effective in accommodating a variety of package types including cold form blister cards, foil pouches, parenteral vials, syringes, pre-filled syringes and unique medical devices.