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Medical devices being extremely sensitive to moisture and oxygen ingress, ensuring their sterility is of paramount importance. Such sterile products are often packaged, transported and distributed to different locations that can expose the package to various humidity levels throughout the distribution cycle. Porous packaging materials are often used by medical device manufacturers for packaging sterile devices. Therefore, maintaining the microbial barrier of porous packages is very crucial.

Read on to know more about the technologies offered by PTI for evaluating the integrity of porous packages, thereby maintaining sterility and microbial barrier.

Porous Package Integrity Techniques:

1. VeriPac Series

Vacuum decay is a test method that has been proven over decades and improved with new technology innovations. PTI has developed Vacuum Decay technology using VeriPac instruments that are recognized by the FDA as a consensus standard for container closure integrity testing (CCIT) and are listed in ISO 11607 and USP Chapter 1207.

VeriPac test systems can be used to inspect a wide range of packaging formats flexible, rigid and semi-rigid packaging. Since this technology is non-destructive, non-subjective and requires no sample preparation, it significantly reduces costs and product waste. VeriPac inspection systems use cutting-edge innovation to provide repeatable, more sensitive, and more robust detection of defects. Apart from container closure integrity testing, VeriPac test systems can be used for stability studies, clinical trials, quality assurance testing and statistical process control (SPC).

Technology Overview

The test begins by connecting VeriPac leak testers to specially designed test chambers. The packages to be tested are placed inside the test chamber and a vacuum is applied. The single or dual vacuum transducer technology is used to monitor the test chamber for both the level of vacuum as well as the change in vacuum over a predetermined test time. The presence of a leak is indicated by a change in an absolute and differential vacuum. VeriPac test systems can be designed for manual or automatic operation.

Benefits of VeriPac Series

• Deterministic, quantitative test method
• Defect detection down to 0.034 cc/min
• Highest level of repeatability and accuracy
• Cost effective with rapid return on investment
• Simplifies the inspection and validation process
• Results proven superior to dye ingress
• ASTM test method and FDA standard
• USP <1207> Compliant

2. Airborne Ultrasound Technology

Airborne Ultrasound technology has established itself as a highly practical solution for non-destructive testing of porous packages. This technology can be applied for 100% defect detection of package seals along with seal quality testing and analysis.

Airborne Ultrasound technology makes use of ultrasound waves to identify defects in package seals. When high-frequency sound waves are passed through the package seal, it causes reflections of sound waves. Variations in signal strength are monitored closely to detect defects. Airborne Ultrasound technology's wide range of applications including Tyvek, paper, foil, film, aluminum, plastic and poly make it a practical option for seal integrity testing across different industries.

PTI has redefined seal integrity testing with its latest improvements in the form of Seal Scan (Offline) and Seal-Sensor (automated online seal inspection). 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.

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.
• ASTM Test Method F3004 and FDA recognized standard for seal quality inspection

Blister packs are pre-formed packaging that are commonly used for tablets, capsules and certain consumer goods. They are made up of two primary components - a cavity made from a form of plastic or aluminum and a covering made from aluminum, paper or a lamination of soft foil. The cavity holds the product while the covering seals the product in the package.

While filling tablets into blister packs, the product is first fed into the desired cavities followed by sealing the cavity covering. Manufacturers of sterile pharmaceuticals highly depend on package integrity testing to verify product quality and safety.

Package Inspection Techniques

1. OptiPac Leak Detection System

OptiPac Leak Detection System is a non-destructive container closure integrity testing method developed specifically for multi-cavity blister packs. This leak detection method uses One-Touch Technology to achieve a rapid test cycle without requiring any changeover or sample preparation. Practical operation, sensitivity and reliability are the key features that make OptiPac technology ideal for blister package inspection.

To conduct the test, the operator places the blister pack on the test plate and presses the start button. The next step involves pulling vacuum to the desired vacuum level. The blisters expand under vacuum, driving air out of the blister through any leaks present. If the pack is defective, the air escapes into the chamber leaving a collapsed blister cavity. Depending on the blister cavity, OptiPac technology provides rapid detection of upto sub-5-micron defects. Additionaally, the technology displays a definitive pass/fail result along with quantitative measurement for each package tested.

2. VeriPac 410 Series

The VeriPac 410 inspection system utilizes a combination of Vacuum Decay technology and differential force measurement for container closure integrity test (CCIT) and leak detection of blister packs, sachets, and pouches with low headspace, such as transdermal patch packaging and suture packs. This technology can be used to test multiple packages in a single test cycle based on the package specifications. Additionally, it can also precisely identify which package or blister cavity is defective. VeriPac 410 inspection systems are proven to provide quantitative test results with a definitive pass/fail result. Being a non-destructive technique, VeriPac 410 allows tested products to be returned to the production line. This eliminates the cost and waste associated with destructive leak test methods. The ROI for the VeriPac 410 makes this a powerful solution for the pharmaceutical industry.

Benefits of VeriPac 410 Series

• Non-destructive, non-invasive, no sample preparation
• Non-subjective, accurate and repeatable results
• Capability to test multiple packages in a single test cycle
• Identifies which package is defective
• Simplifies the inspection and validation process
• Supports sustainable packaging initiatives
• ASTM test method and FDA standard
• Cost effective with rapid return on investment
• Scalable to automated inline testing.

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.