Tyvek® Package Integrity Testing Using Airborne Ultrasound Technology


For decades, Tyvek® has been a reliable choice for medical device and pharmaceutical manufacturers, as well as specialized sterile packaging providers across the world. Since Tyvek® is comprised of HDPE, it can be recycled in accordance with local regulations. Tyvek® is widely used in laboratory and medical device packaging applications both sterile and non-sterile as it can withstand conditions such as gamma irradiation and ethylene oxide gas, which are used to disinfect equipment and surgical instruments. Tyvek is a common material for pouches, lid stock, breather patches, and bag headers. Under the most severe, highly polluted environments, Tyvek® has been found to provide an excellent microbiological barrier.  

Traditional methods like water bath, bubble leak testing methods, and blue dye leak test methods were traditionally used for testing Tyvek® packages. Since these methods offer some limitations, manufacturers rely on non-destructive, deterministic package testing solutions. Airborne Ultrasound technology is one technology that can be used to test Tyvek packages.   

 

Airborne Ultrasound Technology to Ensure Tyvek® Package Integrity 

 

Airborne Ultrasound technology is a deterministic and non-invasive seal quality inspection method. It is widely used for a wide range of materials, including Tyvek®, paper, foil, film, aluminum, plastic, and poly. When a package seal passes through the sensor head, ultrasonic waves propagate through the material, causing the sound waves to reflect. As soon as the defects are detected, the signal strength is reduced/eliminated, allowing the defect to be identified. The greater the acoustic difference between mediums, the more sound is reflected and less sound is transferred through the seal. 

 

Airborne Ultrasound technology has both online and offline solution options for testing the seal. Seal-Scan inspects and analyzes the pouch seal offline whereas Seal-Sensor Airborne Ultrasonic technology inspects the final pouch seal 100% inline. Airborne Ultrasound technology is the standard test technique for evaluating seal quality and integrity, according to ASTM F3004-13. It is one of the most effective non-destructive CCI technologies for testing seal quality flexible products. This test method is also recognized by the FDA as a standard for seal quality inspection.  

 

Benefits of Airborne Ultrasound Technology 

  • Non-destructive, non-subjective, and no sample preparation is required. 
  • Works with any material, independent of color, transparency, print, surface finish, or porosity. 
  • Removes the need for subjective manual vision inspection procedures. 
  • The overall quality and uniformity of the seal are characterized. 
  • An economical and cost-effective approach for testing the seal integrity of the final pouch seal. 
  • Repeatable and reliable results. 
  • Inspect the final pouch seal 100% inline.   

Tyvek® packaging provides an improved microbiological barrier for sterilized medical devices and pharmaceuticals. Other than safeguarding medical devices and pharmaceutical products from physical damage, medical and pharmaceutical packaging should also provide an efficient microbiological barrier and help in preserving the product's sterility. Tyvek®'s unique structure makes it more resistant to microbiological infiltration than other packaging materials. 

 

 

 

 

 

 

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