Blogs CCIT

Jul 2021

Evaluating Sterile Medical Device Package Integrity Solutions

Evaluating Sterile Medical Device Package Integrity Solutions

Package integrity testing of medical devices is important to ensure safety and security of the product throughout its shelf life. Medical device packaging aims to protect the product from physical damage, biological contamination, or any other external disturbance. Technological advancements have offered a wide range of sustainable as well as economical packaging materials and formats to the medical device industry. However, irrespective of whether the devices are packed in rigid thermoformed trays with Tyvek or film lids, or in pouches of porous or non-porous materials or sealed bottles or even blister packs, pharmaceutical package testing is critical to verify that their sterile barrier characteristics are not compromised. Today, the market offers a complete range of technologies that can non-destructively inspect medical device packages for container closure integrity.

Package Integrity Solutions for Sterile Medical Device

1. Airborne ultrasound Technology

Airborne Ultrasound technology is a seal quality testing method, which is capable of non-destructively conducting advanced seal quality inspection of pouches and flexible packaging. It is capable of accommodating multiple packaging materials like Tyvek, paper, foil, film, aluminum, plastic and poly and is also proven to provide deterministic, reliable and accurate test results.

As the name suggests, this method utilizes ultrasound waves to detect defects in package seals. Ultrasound waves are passed through the material as the package seal moves along the sensor head. This causes reflections of sound waves. Such signal strength variations are closely monitored to identify defects if any. Its ability to evaluate seal quality even under conditions where the defect may not result in a leak, makes Airborne Ultrasound technology a practical choice for seal quality inspection across different industries.

PTI’s Seal-Scan (Offline) and Seal-Sensor (Online) are the latest advancements to the ultrasound test series. Both these technologies make use of non-contact airborne ultrasonic testing technology and have been established as one of the most effective methods for inspection of flexible package seals. Airborne ultrasound is also an ASTM Test Method F3004 for seal quality inspection.

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.

2.Vacuum Decay Technology

Vacuum Decay is a non-destructive Container Closure Integrity test method focused on package integrity and detection of leak paths. Compared to manual inspection and other non-deterministic test methods, Vacuum Decay offers quantitative, deterministic and reliable test results to ensure package integrity. Vacuum decay technology is capable of accommodating a wide variety of packaging formats including filled and sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. This test operates by placing packages in a well fitted evacuation test chamber, which has an external vacuum source. The vacuum levels are continuously monitored to identify any variations from a pre-determined targeted vacuum level. A defect in the package will cause air to escape from the package into the test chamber. On the other hand, packages without any defect hold in the air, maintaining constant chamber vacuum level. Vacuum Decay technology has been proven over years to be one of the most practical and sensitive vacuum-based leak detection solutions.

Benefits of Vacuum Decay technology:

  • Non-destructive, non-subjective, no sample preparation.
  • Capable of detecting defects down to 0.05 cm.
  • Accurate, reliable, repeatable results.
  • Supports sustainable packaging and zero waste initiatives.
  • FDA recognized standard for package integrity testing.
  • ASTM test method F2338.
seal quality testing, pharmaceutical package testing, container closure integrity
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