What Makes Package Testing for Medical Devices Effective?

A medical device's packaging is critical to its safe and secure delivery to the market while maintaining its sterile barrier. Nowadays, the medical device packaging sector has been challenged to maintain quality and dependability in packaging due to rapid advancements in medical technology. Inadequate packing poses a threat to the safety of both, the medical equipment and its users. Inspecting packaging for incomplete seals, defects to ensure the package can survive its lifecycle are all requirements for sterile medical devices. Therefore, it is necessary that the packaging must allow its contents to be sterilized and then retain that sterility until usage.

Medical device package testing methods

The testing of medical device packages can be done using the following two methods:

Airborne Ultrasound technology

Airborne Ultrasound for seal quality inspection is an ASTM Test Method F3004 and FDA recognized standard. It is a non-destructive, non-subjective, and deterministic inspection method producing quantitative results. In this technique, sound waves are reflected when ultrasound waves are transmitted through the package seal. It is possible to detect defects by measuring the fluctuation in the intensity of the signal reflected back. If the difference in acoustic properties between the two media is large, more sound is reflected, and less sound is transferred through the seal. It may be utilized with a wide variety of materials, including Tyvek?, paper, foil, film, aluminum, plastic, and poly.?

Vacuum Decay technology?

Vacuum Decay?is an ASTM Test Method F2338 also recognized by the FDA as a Consensus Standard for container closure integrity. Using a vacuum decay test, you can identify leaks in non-porous, rigid, or flexible containers that have no pores. This technology is a non-destructive alternative to the water bath leak test and blue dye leak test method.

Vacuum Decay is a deterministic package integrity test method for evaluating the integrity of medical device packages. When compared to destructive testing, non-destructive testing enhances package quality while reducing waste. Testing with non-destructive methods reduces cost, improves reliability and accuracy of package testing.?

Vacuum Decay technology operates by placing sample packages in a closely fitting evacuation test chamber, which is equipped with an external vacuum source. A single or dual vacuum transducer is used to monitor both the level of vacuum and the change in vacuum over a predetermined period of time in the test chamber. The variations in the package's absolute and differential vacuum indicate the presence of leaks and defects. Vacuum Decay is the most practical and sensitive leak test method available in the market today.

In today's competitive medical device industry, the packaging is just as essential as the medical device itself. ?Packaging is a very important element of the medical device industry, and it comes with its own set of security and safety issues for the patient’s benefit. In order to protect the device while it is being transported or used, the packaging must be sterile.