Industries
Pharmaceutical manufacturing
Continuous manufacturing needs evidence that material spent the time in the vessel your process description claims, and that concentration was where it should be throughout. Offline sampling gives you neither continuously.
The problem
A batch is held for the validated worst-case time because nobody can see the endpoint. A grab sample goes to HPLC and the answer arrives after the decision it was meant to inform. Between samples, an induction period or an impurity excursion happens and never appears in the record at all.
For continuous manufacturing the gap is sharper still: a regulator asks how long material actually resided in the reactor, and a nominal volume-over-flow calculation is not an answer. It describes a reactor that does not exist — one with no dead zones, no bypass and no dispersion.
Where it bites
API concentration & formulation
Track the active through synthesis and formulation instead of inferring it from time.
Learn moreResidence time distribution
The measurement a continuous line has to produce, not calculate.
Learn moreBioprocess & fermentation
Feed on measured substrate rather than a fixed profile.
Learn moreDownstream purification
Watch the separation rather than sample across it.
Learn moreCell culture media verification
Confirm media composition before it reaches the bioreactor.
Learn moreWhat we bring to a regulated site
- Installation Qualification supplied by Paeonia; Operational and Performance Qualification run jointly with your team.
- OQ includes a two-hour warmed-up stability run with temperature logging and a wavenumber accuracy check against a known reference chemical.
- PQ builds the chemometric model against gravimetric mixtures or HPLC and UV-VIS reference values, then validates on representative process conditions.
- Measurements are stored as immutable historical records, which is what matters when a result has to be defended two years later.
- The Plant version under development uses EMA ICH Q7 as its GMP reference; software partner KAX Group supports full GMP compliance with the instrument used as PAT.
- Recirculation loops with valves let known standards be introduced directly for ongoing performance verification — and the 0.1 mL void volume means almost no sample is consumed.
The honest limits
The instrument is a flow cell, not a probe: the sample reaches it through a recirculation loop or a representative sampling point, which has to be designed in. It handles particles <15 µm and viscosity under 10,000 cP, with an inline filter of 15 µm, and it does not measure solids. pH 2–10 on stainless steel wetted parts, with a Hastelloy option for corrosive service.
If your measurement sits outside that, we would rather say so during the feasibility check than after the purchase order.
Tell us the measurement you cannot make today
Describe the stream, the chemistry and the decision it blocks. Where it makes sense we test the technology on your own process samples before you commit.