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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

Package integrity testing may be understood as a set of techniques used to protect the contents of a package from potential physical, chemical and microbial threats. It plays a crucial role in determining and maintaining sterility and shelf life of pharmaceutical products, medical devices, and food and nutrition products. Since such products are extremely sensitive to external environmental conditions, even a minute breach in the package can cause micro-organisms, reactive gases or other harmful substances to enter the product. This can result in serious health issues to the end user and affect brand loyalty of manufacturing companies. As such, testing for leaks is an important aspect of the manufacturing process.

Historically, manufacturers relied on destructive testing methods like Water Bath or Dye Ingress as well as other unreliable methods such as Visual Inspection to test integrity of packages. However, such tests lacked accuracy and reliability in test results. Moreover, being destructive testing methods, it caused damages to the package being tested making it unfit for use. These limitations of destructive techniques prompted manufacturers to opt for non-destructive testing methods that do not harm the product and provide reliable, repeatable and quantitative rest results. Reduction in waste coupled with material cost advantage gives non-destructive methods an practical edge over destructive test methods. Examples of non-destructive testing methods include Vacuum Decay technology, Airborne Ultrasound technology and Microcurrent HVLD technology.

VeriPac test systems for precise and reliable package integrity testing

PTI’s VeriPac series are non-destructive, non-invasive inspection systems for leak detection and package integrity testing. These systems reduce waste and provide operators with a clear understanding of package quality. The VeriPac test system produces real time results from precise quantitative measurements that identify packaging defects before critical process issues get out of control. Tests can be performed in any sequence and even repeatedly on a single sample. Good packages can be returned undamaged to the packaging line. Testing is more reliable, sensitive and efficient than destructive methods. VeriPac series utilizes the ASTM approved patented Vacuum Decay leak test method F2338, recognized by the FDA as a consensus standard for package integrity testing.

Technology Overview

PTI’s VeriPac leak testers connect to a test chamber that is specially designed to contain the package to be tested. The package is placed inside the test chamber to which vacuum is applied. The absolute 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 changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. The test cycle takes only a few seconds, results are non-subjective, and testing is non-destructive to both product and package. The sensitivity of a test is a function of the sensitivity of the transducer, the package design, the package test fixture and critical test parameters of time and pressure. Test systems can be designed for manual or fully automated operation. This inspection method is suitable for laboratory offline testing, QA/QC statistical process control, automated batch or 100% inline testing.

Benefits of VeriPac series

• Non-destructive, non-subjective, no sample preparation
• Deterministic, quantitative test method
• Defect detection down to 0.2 ccm
• High level of sensitivity, repeatability and accuracy
• Short cycle time provides operator with PASS/FAIL result
• Small footprint and modular portable design
• ASTM test method and FDA standard
• Referenced in USP 1207 guidance