Sterile Medical Device Packaging: Quality and Safety Requirements

With the increasing demand for sterile medical device packaging, the testing of its quality and safety has become more stringent. Such packaging (such as blister boxes with Tyvek® lidstock, paper-plastic pouches, etc.) comes into direct contact with the devices and plays a key role in providing a microbial barrier. Regardless of the form, it must meet two fundamental characteristics: the ability to withstand the sterilization process, and the maintenance of sterility during transportation, storage, and until the point of use. Therefore, relevant regulatory authorities are progressively strengthening the review requirements for sterile packaging and specifying more detailed regulations regarding its performance and quality.

Key Standards and Requirements

Among the currently recognized authoritative standards, GB/T 19633.1-2015 "Packaging for terminally sterilized medical devices" holds a significant position. It is equivalent to ISO 11607-2023 and defines the essential performance requirements for sterile packaging, including the biological compatibility, chemical toxicology, microbial barrier performance, seal integrity, and aging performance of the materials. Among these, seal integrity is a critical factor affecting the integrity of the entire sterile barrier system. Once it fails, sterility is compromised, potentially leading to serious medical incidents.

Seal Strength Testing Methods

The standard explicitly lists seal strength as an indispensable safety validation item and proposes two primary testing methods: tensile seal strength testing and burst/creep testing.

Implementation Considerations

It is noteworthy that GB/T 19633-2005 did not elaborate in detail on burst/creep testing. In practice, relevant standards such as ASTM F1140, YY/T 0681, and ASTM F8806 can be referenced to ensure the standardization of the testing methods and the reliability of the results.

In today's climate of increasing emphasis on medical device safety, strictly adhering to standards and scientifically conducting seal strength validation has become a crucial step in ensuring the reliability of sterile packaging and the safety of patients using medical devices.