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Practical guides on the standards and methods behind our instruments — written for the people who have to defend the test at audit, not just run it.
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USP <1207> Container Closure Integrity Testing — A Practical Guide
What the chapter requires, deterministic vs probabilistic methods, acceptance criteria from your own failure modes, and how a pressure-decay CCIT system fits your validation program.
Latest articles
How to Choose a Filter Integrity Tester
What to look for in a filter tester: the five USP <43> methods, PUPSIT under the 2022 Annex 1 revision, records, and qualification documentation.
Bubble Point Testing — A Practical Guide
How the bubble point test actually works, how to set acceptance limits, where it fits in the USP <43> set, and the failure modes that give you wrong numbers.
TOC Testing in Pharmaceutical Water
Why TOC is the watch parameter for pharmaceutical water, the 500 ppb acceptance value, the three-stage determination, and what a TOC analyzer must hold to keep monitoring honest.
Pressure Decay Leak Testing — When to Use It
The physics of pressure decay leak testing, how a leak size becomes a pass-fail line, why the method is non-destructive and in-process capable, and where the MFT series fits.
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