A Targeted Approach
We believe great collaboration starts with deep understanding. Our approach involves a thorough discovery process to understand the unique intricacies of your product, package, and study goals to build custom solutions.
Industry Informed – With origins managing a contract laboratory setting, we have experience delivering successful USP qualification to hundreds of pharmaceutical and biotech package systems.
Research Led – We understand that research is critical to making informed decisions and to the development of any field. That’s why we are dedicated to it – taking time to fully analyze client needs or to develop a custom analytical study to assess package assembly variables.
Data Driven – Identify variables and collect targeted, accurate data that is appropriate to inform study goals.
Results Oriented – Don’t collect data just to collect it. Interpret what results mean and evaluate next steps, leading to the success of your project.
For companies with in-house analytical capabilities, Containsure offers experimental design and custom protocol development for in-depth looks at container closure integrity (CCI) and container performance. Leverage new and existing laboratory equipment to answer new questions.
Compare container components, evaluate equivalency, optimize dimensional stack-ups, and optimize assembly. For a final package system, develop a comprehensive USP / EP compendial test strategy and ultimately component spec sheets that prepares your package for submission to a regulatory agency.
Choosing the right package components is one thing. Ensuring the quality of the final product-package system, especially in the case of sterile parenterals, is something else. Learn how CCI test methods can be used to ensure proper assembly, replace sterility tests during stability, and even help transfer or scale fill-finish to new assembly lines.
Test Lab Concierge
Know what needs to be done, but don’t want to deal with the contract laboratories to do it? Containsure can act as your container testing concierge by obtaining quotations, calculating sample requirements, and managing submissions, timelines, and reports with the selected vendor.
Check back soon for articles and sample presentations on topics such as USP and EP compendial updates and container closure integrity testing.
“For container testing, companies are used to ‘checking the box’. USP philosophy and industry expectation appears to be moving away from this ‘checkbox’ mentality, and toward a ‘toolbox’ mentality with methods and guidances. In other words, ‘here are some tools; use them to demonstrate the suitability of your container-closure system’.”
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Leverage our experience to your success