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PTI is dedicated to advancing Life Science packaging integrity through innovative Container Closure Integrity solutions and expert services. We empower the industry with reliable, non-destructive testing technologies that ensure product safety, regulatory compliance, and quality assurance.

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Container Closure Integrity

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Package & Seal Quality

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Leak Detection

BOTTLES & CONTAINERS

Technologies

Vacuum Decay High Voltage Leak Detection (HVLD) Helium Leak Detection Pressure Decay Airborne Ultrasound Force Decay

Vacuum Decay

Vacuum decay has been substantiated as one of the most practical and sensitive vacuum-based leak detection methods. This test 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.

High Voltage Leak Detection (HVLD)

High Voltage Leak Detection (HVLD) 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 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.

Pressure Decay

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.

Airborne Ultrasound

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.

Force Decay

Force Decay 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.

Dye Ingress

Dye ingress testing is a traditional, qualitative and probabilistic method for assessing container closure integrity. Packages are exposed to colored dye under vacuum or pressure, and dye entry indicates potential leakage. However, negative results may not confirm integrity because pressure differential, exposure time, viscosity, defect characteristics, and package movement affect sensitivity. The test is destructive and does not provide quantitative leak-rate data. Dye ingress is not a PTI technology. PTI provides deterministic alternatives, including Vacuum Decay, HVLD, and Helium Leak Detection, for objective package integrity assessment.

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Leaders in container closure integrity

PTI understands that container closure integrity testing (CCIT) of parenteral products is essential during the entire product lifecycle until it reaches the patient. Any breach in the package can cause product deterioration from microbial contamination, exposure to gases, water vapor and loss of solvent. PTI’s non-destructive inspection technologies verify container closure system integrity with deterministic quantitative test methods for vials, ampoules, syringes, cartridges and auto-injectors.

Tyvek & Porous Packaging

VeriPac inspection systems utilize an ASTM approved 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. This vacuum decay method developed by PTI’s VeriPac instruments are capable of detecting leaks in the single digit micron range.

Flexible Packaging

Seal-Scan® and Seal-Sensor systems utilize non-contact airborne ultrasonic technology for seal analysis of pouches and flexible packaging. This technology is a deterministic, quantitative test method and also an ASTM Test Method F3004-13. Seal-Scan is a high resolution method that inspects and analyzes pouch seals non-destructively offline. Seal-Sensor is designed for 100% online pouch seal inspection.

CCI testing of Intravenous Bags

Intravenous (IV) bags are crucial in delivering fluids or medication quickly. Leaking parenteral packages are considered an extremely high risk as they deliver fluid directly into the bloodstream and have a high potential for microbial growth, requiring the need for sensitive and reliable CCI testing. IV bags can be effectively tested using VeriPac Vacuum Decay technology. PTI’s VeriPac Vacuum Decay technology is capable of detecting package leaks and invisible defects using a differential pressure transducer leak test system.

Tablets & Capsules

Helium leak testing refers to the act of finding leaks in different types of sealed systems using helium as a “tracer” gas. Due to its extreme sensitivity, a helium-based test method has been proven to be the most effective method for determining the integrity of a blister pack. The helium that has been sealed inside the packaging system escapes through tiny channels in the package, and this is how the test procedure detects it.

Bottles & Containers

The VeriCon 126+ is a robust leak test system that operates 24/7 without loss of sensitivity and requires minimal maintenance. PTI’s VeriCon 126+ offers easy plug & play leak testing solutions for inline container testing and for blowmolding lines with trimmer mount configuration.

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Setting the Standard

PTI technologies were used to develop ASTM F2338 Test Method (Vacuum Decay) and ASTM Test Method F3004 (Airborne Ultrasound).

USP Chapter <1207>: Container Closure Integrity Testing Guidance, Package Integrity Test Method Selection and Validation with overview of Deterministic vs. Probabilistic methods.

ISO 11607 and ISO 11608 regulatory guidance documents related to sterile barrier packaging - Requirements for materials and packaging systems.

FDA Recognized Consensus Standards: ASTM F2338 Vacuum Decay Test Method for package integrity testing, and ASTM F3004 Airborne Ultrasound Test Method for seal quality & integrity.

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