Quality White Papers & Case Studies
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.