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Since the number of complex medical devices is rising, including implantable sensors, infusion pumps, and diagnostic instruments, package integrity becomes more important. Most of these need to be handled with utmost care in order not to get contaminated, especially if they are sensitive to moisture and oxygen. Package integrity testing would, therefore, be an optimal way for determining whether the packaging would retain a sterile barrier or not.

Challenges in Medical Device Packaging

Packaging medical devices also incurs numerous environmental challenges. Moisture-sensitive equipment presents the likelihood of being exposed to wet conditions, increasing the susceptibility to compromised product integrity and subsequent health risks. Some of the key issues are as follows:

• Environmental Exposure: Moisture, dust, and other contaminants can degrade device performance if packaging fails.
• Regulatory Compliance: Strict regulations require rigorous testing to ensure packages are sealed and sterile.
• Non-Destructive Testing Requirements: For sensitive devices, packaging tests must be non-destructive, so sample integrity remains intact.

These challenges necessitate advanced testing solutions that can provide accurate, repeatable results without harming the package.

Why is Package Integrity Testing of Medical Device Packaging Important?

Package integrity testing of medical device packaging is crucial because it verifies the packaging’s ability to maintain a sterile barrier, safeguarding the device from contamination and environmental exposure throughout its shelf life. For moisture-sensitive devices, even a microscopic breach can allow microbial ingress or moisture, compromising device safety and efficacy. This testing process helps manufacturers meet stringent FDA and ISO standards, reduce product recalls, and uphold the highest safety standards. Ultimately, package integrity testing not only protects patients but also reinforces a company’s commitment to quality, ensuring that medical devices arrive in pristine condition, ready for safe use.

Ensuring Package Integrity with VeriPac Vacuum Decay Technology

PTI’s VeriPac container closure integrity testing (CCIT) method offers a non-destructive alternative to traditional leak testing methods such as water bath, bubble leak, or blue dye tests. VeriPac systems can be used for integrity testing of Tyvek and other porous packaging, ensuring the product meets regulatory and consumer standards for quality. Introduced in 2003 as an ASTM test method, this vacuum decay technology was initially developed for testing Tyvek-lidded trays.

The VeriPac system works by connecting its leak testers to a test chamber designed to hold the package sample. A vacuum is applied to the package within this chamber, and the level of vacuum, along with any changes in vacuum over a set test duration, is monitored using single or dual vacuum transducer technology. By tracking changes in both absolute and differential vacuum levels, the system can detect leaks or defects in the package with high accuracy.

• Non-destructive test method that ensures quantitative test results
• FDA recognized ASTM test method
• Referenced in USP 1207 guideline
• Cost-effective with rapid return on investment
• Simplifies inspection and validation process