Reduce risk of sterile breaches
Our experience with medical device industry leaders led us to create a concept-to-validation process that saves you time and reduces risk. Our engineering approach allows us to step in anywhere on the packaging journey to keep your project moving forward. We help you ensure compliance with ISO 11607 for validating terminally sterilized medical device packaging.
Packaging Engineering Services
Usability Evaluation
ISO 11607 suggests performing a documented usability evaluation on your device packaging before your medical device is introduced into a healthcare environment. When healthcare professionals are able to open packages aseptically, there are fewer sterile breaches that could impact patient health as well as reduced risk for damage or loss of equipment.
Packaging Design Concept
After performing a technical analysis of your device, we’ll develop competing packaging solutions for your project. As part of our healthcare packaging design process, we’ll work with you to evaluate the options, with cost analyses, high level project plan and scheduling details for each option. This MicroProgram is often used in conjunction with the Feasibility/Proof of Concept MicroProgram.
Feasibility / Proof of Design Concept
Vetting the packaging design concept (yours or ours) is a critical component of successful validation. We perform a series of tests to achieve two things: 1) establish viability of the existing design, and 2) identify potential failure modes for the system. This is a great tool to gain confidence before you spend big dollars on tooling and inventory. Even a small number of dummy samples can give you the results you need.
Turnkey Sealer Validation
Proper sealer validation is a requirement of ISO 11607-2. A thorough qualification provides a strong foundation for your transit and aging validations going forward. Because it’s turnkey, you do nothing. We do all the leg work, from writing the protocols to performance testing and final installation at your facility.
Root Cause Analysis
Transit failures happen. When they do, it’s important to take a systematic approach to finding a solution that will get the project back on track. With this program, our engineers will investigate to determine the exact cause of the failure. From there, we can identify potential options to course correct with the least possible disruption to launch.
Test Method Validation
ISO 11607 requires manufacturers to prove the effectiveness of their methods for lot release testing. A common challenge we see is that of providing proper documentation of test method validation. We have designed a program to provide this documentation as an independent third-party to our clients. This program delivers the assurance you need that your in-house testing methods meet the latest standards.
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