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5 articles tagged PAT.
Twenty years after the first FDA continuous manufacturing approval, the technology is no longer experimental — but adoption is uneven, and the bottlenecks are now organizational, not technical.
A primer on PAT — the FDA-driven framework for measuring chemistry where it happens, why pharmaceutical and chemical manufacturers adopt it, and the tools that make it practical.
Twenty years of guidance documents — 2004 FDA PAT guidance, ICH Q8 through Q14, ASTM E2363 — turned a fragmented vocabulary into a working framework. A reading guide.
A feasibility study costs less than the analyzer and reduces project risk by an order of magnitude. The shape of a useful one — what to measure, on what samples, against what reference, with what success criteria.
A composite of conversations with engineers running multi-site PAT programs. The technical work is straightforward; the parts that go wrong are organizational, contractual, and cultural.