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Testing the integrity of newly developed packaging is a critical step in ensuring that it serves its requirements in every situation. Packaging needs to ensure that it sustains physical and mechanical stress and keeps the contents fresh until they reach the end user. In order to understand how packaging behaves under different circumstances, flexible packaging testing is quite important. Procedures for testing flexible packs are quite different from rigid packaging. Compared to rigid packaging, flexible packaging can present unique challenges in how to test both the integrity of the package and the seal quality. Some of the solutions offered for flexible package testing by PTI.

Flexible package integrity testing techniques

1. VeriPac Flex System

PTI's VeriPac FLEX systems are versatile non-destructive CCIT methods, designed specifically for pouches and other flexible packaging with dry-filled products. The technology utilizes an ASTM method for vacuum decay leak testing (F2338) listed in ISO 11607 and recognized by the FDA as a consensus standard for package integrity testing. PTI's VeriPac FLEX Systems are available in several configurators that can accommodate various package specifications and test sensitivity requirements. Such configurators for both the leak test instrument and the test chamber capacity enable evaluation of small format sachets and stick packs, up to large bulk size pouches and bags. A unique feature of this technology is that it requires no changeover of settings or tooling and is proven to provide high levels of sensitivity, reliability and practicality in testing a complete range of flexible packaging formats and sizes.

Technology Overview

The test begins by connecting the VeriPac tester to the appropriate FLEX chamber based on the size range of the package. The two VeriPac systems paired with the FLEX chamber provide different leak detection capabilities depending on the application. While the integrated flexible test chamber (IFC) is intended for sachets or stick packs with low headspace, the Drawer Style test chamber (D-Series) is ideal for package formats and bulk products. The unique difference with VeriPac FLEX systems is how the package is tested. PTI utilizes its flexible membrane that conforms to the package shape and size, eliminating any stress and damage to the film materials. Multiple packages can be tested in a single test cycle.

Benefits of VeriPac Flex System

• Non-destructive, non-subjective, no sample preparation.
• Deterministic, quantitative test method.
• Test multiple packages in a single test cycle.
• Cost effective with rapid return on investment.
• Supports sustainable packaging and zero waste initiatives.
• Simplifies the inspection and validation process.
• Accurate and repeatable results.
• ASTM test method and FDA standard.
• USP < 1207> compliant

2. Airborne Ultrasound Technology

PTI's Airborne Ultrasound technology is a non-destructive and non-invasive seal quality inspection method. The test is conducted by allowing ultrasound waves to pass through the package seal causing the reflection of sound waves. To identify the defects, variations in the reflected signals’ strength are analyzed. PTI offers two configurations of Airborne Ultrasound testing technology; Seal-Scan® and Seal-Sensor.

Seal-Sensor™ is a deterministic, quantitative method that inspects the final pouch seal non-destructively 100% online. Seal-Sensor detects incomplete seals, partial or weak areas in seals, and many common defects in seals that appear visually acceptable yet possess defects that affect product quality, value and shelf-life.

Seal-Scan® is an Airborne Ultrasonic Technology (ABUS) that inspects and analyzes pouch seals non-destructively offline for in-depth seal quality evaluation and analysis. Seal-Scan® is a semi-automatic inspection system with x-y drive, used for the detection of seal defects, seal characterization and material analysis.

Advantages of PTI’s Seal Scan and Seal Sensor Method:

• Deterministic seal quality inspection method that produces quantitative results.
• This method works for any material type and combinations regardless of color, transparency, print, surface finish or porosity.
• Non-destructive and non-subjective test method that requires no sample preparation.
• Technology can be integrated for 100% online defect detection of the final pouch seal.
• Repeatable, reproducible and reliable results for seal quality inspection.
• Cost-effective solution for seal integrity testing and seal analysis that characterizes overall quality and uniformity of the seal.

Medical devices are available in a variety of forms with complex geometric attributes such as valves, tubes and others that can complicate the medical device testing process. Hence, medical device leak testing equipments are expected to provide high levels of sealing effectiveness and test result sensitivity to narrow down the complexities.

Medical Device Package testing using Seal Scan technology

Seal-Scan® is a deterministic, quantitative, high-resolution method based on is an Airborne Ultrasonic Technology (ABUS). It is highly effective in non-destructively inspecting and analyzing pouch seals for defects and seal integrity for consistency. Seal-Scan systems utilize the ASTM Test Method F3004-13, which is a non-destructive test method for evaluating seal quality and integrity using Airborne Ultrasound technology. The test procedure is simple, quick and requires no sample preparation. Additionally, Seal-Scan® provides advanced digital imaging software tools for process control which offers in-depth seal quality analysis.

Seal-Scan features two scan modes:

• Linear Scan (L-Scan) to simulate online defect detection (line graph)
• C-Scan for detailed seal analysis, producing pixel by pixel evaluation of seal (Opto-Acoustic image)

Technology Overview

The test beings by scanning the pouch seal or package material between two focused ultrasonic sensors. Ultrasonic waves propagate through single or multiple layers of bonded materials. As the ultrasonic waves propagate through different mediums, it causes reflections of sound waves, which reduces/eliminates signal strength. The level of signal passing through the seal is a function of the quality of the seal. Various types of defects; leaking and non-leaking, process-related and random are detectable.

Seal scan has two scan modes (L-Scan and C-Scan) that is capable of producing Opto-Acoustic images as well as detailed statistical analysis. An L-Scan is a single linear scan along the X-axis of the seal that provides a line graph of seal integrity and simulates online inspection. C-Scan produces multiple scans (along X and Y-axis of seal area) that provide a high-resolution ultrasonic image of the seal structure. This technology can be integrated into a pouch production line via the Seal-Sensor for 100% fully automated on-line seal defect detection.

Benefits of Seal Scan Technology

• Deterministic inspection method producing quantitative results.
• Works for any material and combinations, regardless of color, transparency, print, surface finish and porosity.
• Produces high resolution Opto-Acoustic image of seal.
• Characterizes overall quality and uniformity of the seal.
• ASTM Test Method F3004 and FDA recognized standard for seal quality inspection.

The World Health Organization (WHO) has stated that healthcare associated infections pose the highest risk in the delivery of healthcare services globally. This causes a serious threat to millions of patients worldwide every year. Therefore, ensuring sterility of medical devices is an important way to reduce the risk associated with faulty medical devices in hospitals and other healthcare settings.

Appropriate packaging and packaging materials are crucial to help preserve sterility of medical devices. Conventionally, medical device manufacturers relied on manual visual inspection as a method for assuring quality. However, such methods lacked accuracy and reliability in test results. To overcome the limitations of traditional test methods, manufacturers moved towards deterministic Container Closure Integrity testing (CCIT) methods that ensured quantitative and accurate test results.

PTI’s Airborne Ultrasound technology is a seal quality inspection test method, capable of non-destructively examining seal quality for defects. It is an ASTM Test Method F3004 and FDA Recognized Standard for seal quality testing. Such tests are mainly conducted to provide enhanced seal quality inspection of pouches, flexible packages and tray seals. Airborne Ultrasound technology ensures in-depth seal quality analyses and is applicable for multiple packaging materials Tyvek, paper, foil, film, aluminium, plastic and poly. According to Oliver Stauffer, CEO of PTI-Packaging Technologies & Inspection, “Ultrasound is one of the only technologies that are telling us what the quality of that physical bonded nature of the seal materials are.”

Under this technology, ultrasound waves are passed through the package seal which causes reflections of sound waves. The signal strength is reduced or eliminated in the presence of a leak/ defect. Such variations are closely observed to identify the leak. Inability to detect non-leak defects is a common challenge faced by most leak test methods. However, with Airborne Ultrasound technology, users are able to identify various types of seal defects; visible and invisible, leaking and non-leaking, process-related and random.

PTI has redefined seal integrity testing with its latest improvements in the form of Seal Scan (Offline) and Seal-Sensor. Both these technologies utilize non-contact airborne ultrasonic testing technology. With the advancements in form of Seal Scan and Seal-Sensor, Airborne Ultrasound technology has been proven to be the most effective method for non-destructive seal integrity testing, in both offline laboratory testing for seal quality analysis and 100% inline testing on the production line.

Benefits of Airborne Ultrasound technology:

• Deterministic seal quality inspection technique that assures quantitative and reliable results.
• Applicable for multiple material types and combinations regardless of color, transparency, print, surface finish or porosity.
• Eliminates subjective manual inspection methods.
• Non-destructive, non-subjective, no sample preparation
• Technology can be integrated for 100% online defect detection of the final pouch seal.

Seal integrity is the key to ensuring quality of packaging goods. Testing the integrity of package seals helps ensure that packaging provides sufficient product protection. Seal quality test analyses the mechanical strength of the seal thereby securing appropriate material bonding to maintain package quality throughout the product’s shelf life. Any defect in the seal can initiate a leak and will contaminate the product while directly harming its shelf life. With the increasing trend towards flexible packaging, the demand for seal testing has readily grown. Since flexible packaging involves using materials that are sustainable, environment friendly and lower in cost it is essential to ensure that the seals of such package remain intact from the point of manufacture throughout its distribution and use. Seal integrity testing is widely used in different industries including Pharmaceutical, Medical Device, Food & Beverage, Nutrition, Bottles & Containers.

Destructive Vs. Non-Destructive Test Methods

Destructive methods are identified as methods that may damage the product during the assessment and even though the seal passes the test the product becomes useless. Since these tests were incapable of finding non-leaking seal defects, demand for such tests has steadily declined. Traditional test methods like peel strength burst or fish tank bubble come under this category.

Unlike destructive methods, non-destructive test methods are those that do not harm the product and they can be returned to the mark after testing. Reduction in wastage coupled with material cost advantage gives non-destructive methods an edge over destructive methods. According to Oliver Stauffer, Chief Executive Officer at PTI - Packaging Technologies & Inspection “There is a huge shift in the industry toward deterministic and quantitative test methods”. Non-destructive test method can be of the following types:

• 1. Vacuum decay test
• 2. Ultrasonic seal test

Vacuum Decay Method (VDM) is used by manufacturers of packages for the food, beverage, industrial and pharmaceutical industries in order to detect leaks in rigid or flexible packages.

Ultrasonic seal test is an innovative non-destructive Seal Integrity Test used to examine seal quality for defects. The ultrasonic seal test has wide application and is primarily used to detect any defects in the seal area. PTI uses Airborne Ultrasound technology which is a non-destructive and non-invasive seal quality inspection method. “Ultrasound is one of the only technologies that are telling us what the quality of that physical bonded nature of the seal materials are,” says Oliver Stauffer, CEO of PTI. This method is applicable for many materials types such as Tyvek®, paper, foil, film, aluminum, plastic & poly. The test is conducted by allowing ultrasound waves to pass through the package seal causing the reflection of sound waves. To identify the defects, variations in the reflected signals strengths are analyzed

PTI offers two variants of Airborne Ultrasound testing technology; Seal-Scan® and Seal-Sensor. The Airborne Ultrasound testing technology creates a quick analysis of the seal area without tampering with the packaging to identify defects such as incomplete or missing seals, wrinkles, channel defects, and so on. The technology is in high demand due to its applicability across different industries.

• 1. Provides quantitative results using non-destructive seal quality inspection
• 2. Accurate and reliable outcome
• 3. Cost-effective
• 4. Can be used on materials like Tyvek®, paper, foil, film, aluminum, plastic & poly