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CDER says MDIs need clear propellant‑compensation plans and representative sampling
Summary
Presenters warned that propellant evaporation into MDIs' pressurized tanks can change drug/propellant concentration and that sponsors often lack justification for propellant compensation and adequate in‑process sampling to show product uniformity.
Vikkiha described metered‑dose inhaler (MDI) manufacturing steps — liquid compounding, valve crimping/filling, water‑bath stress testing, functional valve performance testing and canister assembly — and said MDIs have particular risks because pressurization complicates representative sampling.
She highlighted inadequate justification for proposed propellant compensation as a recurring deficiency and urged that theoretical calculations be supported by in‑process data verified before and after compensation points. She also said product‑uniformity sampling during filling must be representative and adequately calibrated to demonstrate consistent mixing and filling despite pressurization. "If it's a inline automated field verification system, make sure that there's adequate calibration for that method," she said.
