Quality White Papers & Case Studies

1. Correlating Stopper Height To Container Closure Integrity 11/21/2023

   Learn how to comply with the new EU Annex 1 Section 8.28. Here, we describe a typical raised-stopper investigation and demonstrate how to generate scientifically robust data using headspace analysis.

2. Extractables And Leachables: Risk Management And Analytical Solutions 10/11/2023

   Partnering with a CDMO that offers comprehensive and robust E&L studies can help facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitigating risks.

3. Helium Leak Detection On Plastic Ophthalmic Containers 6/8/2023

   A major pharmaceutical entity wanted to ascertain their container system's seal quality. Explore results from a series of leak testing projects that highlighted key issues with their plastic containers.

4. Correlating Laser-Based Headspace Analysis To Helium Leak Rate Testing 5/22/2023

   Laser-based headspace analysis is a non-destructive and rapid method for testing container closure integrity. We demonstrate that headspace analysis is equally as sensitive as helium leak rate testing.

5. Effects Of X-Ray Inspection On Pharmaceutical Products 3/7/2023

   Some manufacturers still have reservations about adopting X-ray inspection as a safe method of product inspection. Explore the potential effects of X-ray inspection on pharmaceutical products and more.

6. CCIT Comparative Study Between Dye Ingress And Deterministic Methods 1/13/2023

   Explore the results of a unique comparative study of CCIT, and find a suitable deterministic test method to replace the blue dye test that follows the latest guidelines.

7. Helium Leak Detection And Vial Crimp Force Measurements 12/1/2022

   A global pharmaceutical equipment entity was interested to see how various levels of crimping force in vials affect helium leak rate data. Explore the results obtained from this case.

8. Cold And Ultra-Cold Vial Helium Leak Testing 11/22/2022

   A global pharmaceutical entity was comparing vials for helium leak testing services. Explore the results obtained from collecting and tabulating the helium leak rate data as well as the solution.

9. Helium Leak Detection Vs. Dye Leak Testing 11/22/2022

   A global pharmaceutical entity was experiencing early package failures from stability studies for a new drug product. Learn about the solution and the results obtained from this case.

10. Serialization And Traceability Compliance In Pharma And Med Device 10/28/2022

    Explore the role of traceability and serialization and the benefits they offer beyond compliance. Further, gain perspective on how to approach UDI implementation and choose an appropriate solution.