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Ensuring the sterility and integrity of medical device packaging is a critical component in the healthcare and pharmaceutical industries. Tyvek®-lidded trays are commonly used in the healthcare sector to package sterile medical devices, surgical instruments, and pharmaceutical products. Tyvek®, a brand of flash-spun high-density polyethylene fibers, is known for its exceptional strength, resistance to microbial penetration, and compatibility with sterilization methods such as ethylene oxide and gamma irradiation. The lidded trays provide a secure environment, ensuring the packaged contents remain sterile and ready for use when required.

Why is Package Integrity Testing Important?

The integrity of medical device packaging plays a crucial role in maintaining sterility and ensuring patient safety. Any compromise in the packaging can lead to contamination, rendering the medical device unsafe for use. Package integrity testing identifies defects such as leaks, weak seals, and pinholes, ensuring the packaging meets stringent quality standards. By verifying the robustness of the package, manufacturers can mitigate risks, comply with regulatory requirements, and uphold their commitment to delivering safe and effective products.

Package Integrity Testing Using VeriPac Vacuum Decay Technology

VeriPac’s Vacuum decay technology is a non-destructive container closure integrity testing (CCIT) method that accurately detects leaks and ensures package integrity without damaging the test sample. The process involves placing the Tyvek®-lidded tray in a specially designed test chamber and applying vacuum. Any loss of vacuum within the chamber indicates the presence of leaks or defects in the packaging. The VeriPac system’s advanced sensors and algorithms provide highly sensitive and repeatable results, making it a trusted choice for manufacturers.

Benefits of the VeriPac Series

VeriPac series offers several advantages for package integrity testing:

• Non-Destructive Testing: Unlike traditional destructive methods, vacuum decay testing preserves the integrity of the tested package, allowing it to be returned to the production line.
• High Sensitivity: The technology detects microleaks as small as 1 micron, ensuring comprehensive quality assurance.
• Versatility: VeriPac systems are compatible with a wide range of package types and materials, including Tyvek®-lidded trays.
• Efficiency: Automated testing minimizes human error, reduces testing time, and improves overall productivity.
• Regulatory Compliance: VeriPac systems meet the requirements of ASTM F2338, the standard test method for non-destructive detection of leaks in packaging. PTI’s VeriPac instruments were used in the development of this ASTM method, which is also an FDA standard for package integrity testing.
• Cost Savings: By eliminating the need for destructive testing and reducing product waste, the VeriPac series contributes to significant cost savings over time.

Vacuum decay testing represents a paradigm shift in the approach to package integrity testing, particularly for Tyvek®-lidded trays. With its non-destructive nature, high sensitivity, and compliance with industry standards, VeriPac’s vacuum decay technology ensures that medical packaging meets the highest quality standards. By leveraging this innovative technology, manufacturers can safeguard product sterility, enhance patient safety, and maintain their reputation for excellence in the medical and pharmaceutical industries.