Quality White Papers & Case Studies

  1. OEE And Product Inspection 2/13/2025

    Explore the calculation of Overall Equipment Effectiveness (OEE) and the impact of product inspection equipment on OEE in the pharmaceutical industry.

  2. Development Of A Container Closure Integrity Test Method For Autoinjectors 9/30/2024

    Explore how a non-destructive method can be developed to test container closure integrity in autoinjectors equipped with an optically transparent window.

  3. What Pharma And Biopharma Should Know About Container Closure Integrity 8/1/2024

    Explore high voltage leak detection, headspace analysis, and vacuum and pressure decay as applied in pharmaceutical manufacturing.

  4. Inspecting On The Edge — Understanding Punch Tip Wear 7/30/2024

    Why is a horizontal optical comparator highly recommended for tablet manufacturers as a measuring tool for punch tip inspection, and what strategies can be used to detect, reduce, and prevent tip wear?

  5. Microbial Challenge In-Use Studies 6/13/2024

    Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.

  6. 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.

  7. 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.

  8. 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.

  9. 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.