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The role of packaging in the secure delivery of nutritional products to the end-user can never be overlooked. Packaging determines the quality and safety of the contents that reach the customer. Most nutritional products are oxygen-sensitive in nature, therefore package performance is a common cause of concern. Defects in packaging can allow air, moisture, and microorganisms to enter the products, making it unfit for consumption. This is why manufacturers stress package integrity testing of nutritional products before they are dispatched. For testing the integrity of nutritional packages, PTI has developed two technologies: Vacuum Decay and Airborne Ultrasound.

Package Inspection Techniques Offered by PTI

1. Airborne Ultrasound Technology

Airborne Ultrasound is a non-destructive seal quality inspection test method used primarily for evaluating seal quality. Such tests offer enhanced seal quality inspection of pouches, flexible packages and tray seals. Airborne Ultrasound technology has proven capability of providing deterministic, reliable and accurate test results across a wide range of packaging materials including Tyvek, paper, foil, film, aluminum, plastic and poly. It is an ASTM Test Method F3004 and FDA Recognized Standard for seal quality testing.

Airborne Ultrasound technology utilizes ultrasound waves to detect defects in package seals. As the package seal moves along the sensor head, ultrasound waves are passed through the package seal, causing reflections of sound wave. If there is any defect in the package, the signal strength is reduced or even eliminated. Such variations are closely observed to identify defects in the seal.

Benefits of Airborne Ultrasound Technology:

• Deterministic seal quality inspection technique that assures quantitative and reliable results.
• Creates a visual image of seal quality.
• 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.

2. Vacuum Deacy Technology

Vacuum Decay is a Container Closure Integrity test (CCIT) method, proven over decades to ensure package integrity at the production line with unmatched reliability and sensitivity. Being a non-destructive test method, it allows a greater understanding of package quality and reduces waste compared to destructive test methods. The standard vacuum decay leak test method (ASTM F2338), developed using PTI's VeriPac instruments, is recognized by the FDA as a consensus standard for container closure integrity (CCI) testing. The test method is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207).

With the next generation of VeriPac test systems, PTI brings a tradition of excellence and performance reliability to its line of non-destructive package testing equipment. VeriPac test systems have undergone technological advancements across the product line, improving each model to better perform for their respective applications.

Primary areas of focus in terms of innovations in the field of vacuum decay have been improving the practicality and sensitivity of the test method. PTI's VeriPac test systems combine both technological innovation and practical adjustments to current technology to make it the most sensitive and versatile vacuum-based leak detection technology to date. Features like unique test cycles, pneumatic controls and processing algorithms make VeriPac technology the foremost vacuum-based leak detection technology.

Benefits of Vacuum Decay Technology:

• Non-destructive technology.
• ASTM Test Method F2338, FDA Consensus Standard and referenced in USP 1207 Guidelines.
• Accurate, repeatable results.
• Eliminates destructive, subjective testing methods.
• Pass/fail results backed by quantitative test data.

Medical devices play a key role in the diagnosis and treatment of many conditions and life saving treatments. To insure patient safety, the effectiveness of such medical devices should be carefully evaluated. Package integrity testing of medical devices is a crucial part of the manufacturing process.

Medical device package testing methods offered by PTI

PTI’s Airborne Ultrasound technology (ABUS) is a seal quality inspection test method, capable of non-destructively examining packaging seal quality for defects, primarily flexible packaging seals. Under this method, ultrasound waves are passed through the pouch seal, creating a reflection of sound waves. The signal strength variations are analyzed to identify the presence of seal defects. Airborne Ultrasound technology creates a quick analysis of the seal area without tampering with the packaging to identify many common seal defects, such as incomplete or missing seals, wrinkles, and channel defects. The technology is in high demand due to its applicability across several industries, specifically the medical device industry. “Ultrasound is the only technology capable of identifying what the quality of that physical bonded nature of the seal materials are,” comments Tyler Harris, applications engineer at PTI- Packaging Technologies & Inspection. Medical device packaging including TYVEK® pouches is a very common application for ABUS technology.

PTI's Seal Scan (Offline) and Seal-Sensor (Inline) technology have further redefined pouch seal integrity testing. Both these technologies utilize non-contact airborne ultrasonic testing technology. With these advancements, Airborne Ultrasound technology has positioned itself to be the most sensitive method for non-destructive seal quality testing, in both the laboratory and in automated 100% inline testing production lines. ABUS is an ASTM Test Method F3004, recognized by the FDA as a standard for seal quality inspection and also referenced in the USP 1207 chapter guidelines.

For several decades, Vacuum Decay has been proven to be the most practical and sensitive leak detection method for medical device and pharmaceutical packaging. It is a Container Closure Integrity Test (CCIT) capable of evaluating a wide range of packaging formats including filled and sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. Vacuum Decay, being a non-destructive test method, does not cause any damage to the package being tested. This reduces significant waste and allows operators to have a thorough understanding of package integrity and package quality.

PTI’s VeriPac inspection technique is an ASTM approved (F2338), FDA recognized testing method capable of evaluating a wide range of high-risk package applications. To conduct this test, packages are first placed in a well-fitted evacuation test chamber, which has an internal or external vacuum source. The test operator continuously monitors the vacuum levels to identify variations from a pre-determined targeted vacuum level. In the presence of a defect, air escapes from the package into the test chamber. Packages without any defect retain the air, maintaining a constant chamber vacuum level. It is an ideal solution for medical device manufacturers to assure that the product meets regulatory standards. Based on the packaging materials used and the level of test sensitivity required, manufacturers can select the appropriate VeriPac model.

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