FEATURED ARTICLES
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ICH Revises Q1 Guideline, Advancing Stability Testing Standards
In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.
WHITE PAPERS & CASE STUDIES
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OEE And Product Inspection
Explore the calculation of Overall Equipment Effectiveness (OEE) and the impact of product inspection equipment on OEE in the pharmaceutical industry.
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Development Of A Container Closure Integrity Test Method For Autoinjectors
Explore how a non-destructive method can be developed to test container closure integrity in autoinjectors equipped with an optically transparent window.
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What Pharma And Biopharma Should Know About Container Closure Integrity
Explore high voltage leak detection, headspace analysis, and vacuum and pressure decay as applied in pharmaceutical manufacturing.
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Inspecting On The Edge — Understanding Punch Tip Wear
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?
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Microbial Challenge In-Use Studies
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.
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Correlating Stopper Height To Container Closure Integrity
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.