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Medical Device Package Testing


Medical Device Packaging

The medical device industry continues to innovate products for patient care. Medical devices have a broad range of package and delivery systems, from porous flexible packaging to non-porous rigid containers. CCIT is committed to the safety and sterility of medical devices delivered to the surgical environment.

Class III medical devices present the highest level of risk associated with maintaining the sterile barrier of a package. These are devices that are used to sustain, and support life and are mostly implanted. Devices like pacemakers, cardiovascular stents, respiratory ventilators, breast implants etc., come under the category of class III medical devices. The broad product types and package presentations each offer different inspection challenges to assure quality. The medical device industry has long relied on manual visual inspection as a method for assuring quality. Many studies and historical industry data show that manual visual inspection is highly susceptible to failure. Industry regulatory bodies and guidance documents are all driving towards a safer more reliable future for the field of medical device quality.


Medical Device Packaging Testing

Inspection methods that provide faster, more reliable, more sensitive and traceable data are now the standard. Guidance documents such as ISO 11607 provide a menu of methods that improve the package quality for today’s standards. CCIT s.a. offers both in-depth feasibility studies, test method development and test equipment to bring the highest level of quality to high-value medical device applications. The PTI inspection solutions are unique in both sensory technology, performance and reliability.

The quality testing of medical device packaging is of vital importance in delivering the devices from its place of origin to the market maintaining sterility until the time of use. The type of packages for medical devices is determined by the characteristics of the device being packaged. Various factors like size, shape, profile, irregularities, density, weight and configuration are taken into consideration while deciding the package type for medical devices. The raw materials used for medical device packaging must be safe, traceable and effective in providing a microbial barrier and prevent physical damages during the distribution process.

PTI’s Airborne ultrasound is a non-destructive physical inspection method to assure the quality of package seals both offline for in-depth seal quality analysis and for 100% online pouch seal inspection. This ultrasound technology is a true non-destructive method effective for Tyvek® packaging and is also an ASTM Test Method ASTM F-3004-13. This Test Method is also an FDA Recognized Consensus Standard for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound. The ASTM F-3004-13 Test Method was approved based on the PTI sponsored inter-laboratory research program and is one of the most effective methods for medical device package seal inspection. Airborne ultrasound technology is also referenced in the USP <1207> Chapter guidance for deterministic test methods.

PTI’s vacuum-based leak detection systems offer the ability to inspect both the package body and seals for micro leaks. VeriPac inspection systems utilize an ASTM approved vacuum decay leak test method (F2338) recognized by the FDA as a consensus standard for package integrity testing. This test method was developed using PTI’s VeriPac leak test instruments. Vacuum decay technology is also referenced in the USP <1207> Chapter Guidance as a deterministic test method for package integrity testing.

The array of technologies and the active package testing laboratory of CCIT s.a. in St-Prex, Switzerland offers the European medical device market access to some of the best medical device package inspection solutions for class III medical devices.

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