Three Fundamental Requirements for Medical Device Packaging

The sterile barrier system is designed to prevent microbial contamination of medical devices. Together, the medical device and packaging system ensure product efficacy and safety, guaranteeing reliable performance when the device reaches end-users.

The relationship between medical devices, packaging systems, and sterilization is interconnected, mutually restrictive, and interdependent. The packaging component serves as the critical link between these elements. Medical device blister packaging materials must meet the following essential requirements:

1. Functional Integrity

The structural design must provide complete protection for the medical device throughout its lifecycle.

2. Safety & Compliance

Materials must satisfy biocompatibility standards while ensuring compatibility with the medical device itself.

3. Hermetic Sealing Performance

The sealed package must effectively prevent microbial ingress from ambient air, demonstrating excellent barrier properties.

PETG has become the industry-recognized material meeting all three requirements, fully compliant with ISO 11607 standards for microbial barrier systems. With experience serving thousands of clients, Yinso Packaging has witnessed numerous cases where cost-driven packaging decisions resulted in non-compliance and forced manufacturers to seek new suppliers. Our conclusion remains clear: the most costly expense is packaging failure.