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Vacuum decay has been substantiated as one of the most practical and sensitive vacuum-based leak detection method. This test most gives a reliable, reproducible and accurate quantitative result and a pass or fail determination. The ASTM F2338 standard vacuum decay test method was developed using PTI’s VeriPac instruments. It is also listed in ISO 11607 and referenced in United States Pharmacopeia Chapter on CCI. VeriPac's non-destructive technology is capable of detecting package leaks and invisible defects using absolute pressure or differential pressure transducer leak test system.
PTI packaging and inspection systems revolutionized the conventional HVLD method and introduced a groundbreaking new technology for the integrity testing for all parenteral and biological products including low conductivity liquids such as sterile water for injection (WFI). This unique method known as the 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. The Microcurrent HVLD test method is capable of detecting the presence and location of pinholes, micro-cracks, stopper/plunger leaks, non- visible leaks under crimping and many other defects.
Helium Leak Detection
Helium leak testing is defined as the act of finding leaks in different types of enclosed or sealed systems using helium as a “tracer” gas and its concentration is measured as it escapes due to leakage. A vial, consisting of a container and elastomeric closure, is a good example of a package system. A vial is helium-filled & is subjected to vacuum. The amount of helium escaping that package is quantitatively measured and stated as a leak rate. Other examples include a prefilled syringe, a foil pouch or a cold form blister card. Each of these package types is designed and intended to keep the drug product contained while keeping out any detrimental environmental contaminants, such as debris, microorganisms, or even gases. The helium leak detection method has the sensitivity to evaluate each of them.
A strong seal is not necessarily an airtight one, and the flow of gas or liquid through the seal (leak) is just one type of seal defect. As such, there is a fundamental challenge to any leak testing method, whether it is a fish tank-bubble, vacuum deferential, or helium test: none of these methods detect non-leaking seal defects. PTI’s proprietary Airborne Ultrasound technology is a non-destructive and non-invasive seal quality inspection method that can be used for many material types such as Tyvek, paper, foil, film, aluminum, plastic & poly. Various types of defects, visible and invisible, leaking and non-leaking, process-related and random, are detectable. Airborne ultrasound is an ASTM Test Method F3004 and an FDA recognized standard for seal quality testing.
Automated Inline Solutions
Automation and digital measurement systems have systematically become a greater part of pharmaceutical manufacturing. The ability to capture better quality data and provide a seamless data integrity solution is critical to all applications. In addition to offline laboratory systems for leak detection and package quality testing, we offer configurations that provide the capability of fully automated inspection. Automated Systems have been designed using PTI’s Vacuum Decay, MicroCurrent HVLD, Airborne Ultrasound and Force Decay technologies for applications that include automated statistical process control (SPC) testing up to fully automated robotic pick and place package handling.
Various applications like plastic bottles and containers food, beverage and pharmaceutical industries require online leak detection of empty containers before filling and sealing process. Leak testing is also an essential step to assure complete container integrity. PTI’s VeriCon Series offers a complete line of leak tester configurations to accommodate various container specifications and application specific test performance using the pressure decay leak testing method. All VeriCon systems utilize high resolution non-drifting transducers (either pressure transducers or vacuum transducers) for consistent leak detection. Online linear test configurations and trimmer mount systems are available. PTI is known for the most reliable trimmer mount leak testers for blow molding installations due to their reliability and performance.
The VeriPac 410 inspection technology platform combines the sensitivity and reliability of PTI’s vacuum decay technology while introducing a force-based measurement to enhance results. The 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. The VeriPac 410 force decay technology has been successfully validated on multiple package categories including blister packages, transdermal patch sachets, and low headspace suture packs.
The OptiPac One-Touch Tool-less system is designed for non-destructive blister package leak detection. The OptiPac uses a volumetric imaging technology to measure the motion of a blister package under vacuum to detect leaks. The interface is practical and simple to setup with new blister package formats, requiring no tooling changeover or complex parameter adjustments experienced with other non-destructive blister package inspection systems. The system captures the volumetric data from each cavity, adapting to different cavity shapes, sizes and arrangements of different blister pack formats.
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