How Seal Integrity Testing Aligns with Medical Device Packaging Standards

Medical device manufacturers are responsible for ensuring that their products are safe and effective for use. This includes ensuring that the packaging is intact and sterile. Seal integrity testing is a critical part of medical device packaging quality control, as it helps to identify and eliminate any defects that could compromise the sterility of the product.

Seal integrity testing is a process of evaluating the strength and effectiveness of the seals on medical device packaging. This can be done using a variety of methods, including:

· Visual inspection: This involves visually examining the seals for any defects, such as gaps, tears, or wrinkles. Typically visual inspection is performed by a human operator.

· Non-destructive testing (NDT) methods: These methods use various technologies to evaluate the seals without damaging the packaging. Vacuum decay and airborne ultrasound are two non-destructive solutions for package & seal integrity testing.

· Bubble leak testing: This method uses a vacuum chamber to create a pressure differential between the inside and outside of the package. If there is a leak in the seal, bubbles will form on the outside of the package[MW1] .

· Dye penetration testing: This method uses a dye to be applied to the outside of the package. If there is a leak in the seal, the dye will penetrate the packaging and be visible on the inside.

· Airborne ultrasound technology: This method uses high-frequency sound waves to detect defects in the pouch/flexible packaging seals.

Why is Seal Integrity Testing an Integral Part of Medical Device Packaging Quality Control?

Seal integrity testing is an integral part of medical device packaging quality control because it helps to ensure that the packaging is intact and sterile. A compromised seal can allow bacteria and other contaminants to enter the package, which can put patients at risk of infection. Seal integrity testing is also important for regulatory compliance. The FDA requires medical device manufacturers to have a quality system in place that includes seal integrity testing.

Seal Integrity Testing using Airborne Ultrasound Technology

Airborne Ultrasound technology is a non-destructive, non-contact method of seal integrity testing. It works by emitting a high-frequency sound wave and detecting any reflections from the seal. If the seal is intact, there will be no reflections. However, if the seal is compromised, the signal wave variation in dicates a change in signal strength and presence of defects. Airborne Ultrasound technology is a very sensitive and reliable method of seal integrity testing. It can be used to test a wide variety of seals, including those made from a variety of materials. The technology is also very fast, allowing for rapid testing of packaging on production lines.

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

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