Reproducibility is an equipment question as much as a chemistry one. Our reactor platforms hold temperature, agitation and addition to the precision that makes a crystallization repeatable.
Our controlled reactor platforms enable precise, reproducible crystallization and synthesis across development scales — providing the control needed to develop and refine robust processes.
Crystallization is unusually sensitive to how an experiment is run. The same solvent system and the same concentrations can give different forms, different particle sizes and different filtration behaviour depending on cooling rate, agitation intensity, addition profile and the thermal history of the vessel. Run by hand, those variables drift; run in a controlled reactor, they become parameters you can set, record and reproduce.
That difference matters twice. During development, it means a result can be repeated and therefore trusted. At transfer, it means the process can be described in numbers the receiving site can dial in, rather than in procedural habits that do not travel.
The reactors are used across the whole development range, from screening-scale vessels to the kilo-lab.
Programmed cooling and heating profiles with jacketed temperature control, so the supersaturation trajectory is set deliberately rather than by ambient conditions.
Controlled and recorded stirring regimes, which govern nucleation, crystal growth, agglomeration and attrition.
Programmed dosing of anti-solvent, reagent or seed suspension at defined rates, one of the strongest levers on particle size distribution.
Every run logged, so that batches can be compared against each other on data rather than on recollection.
Repeat execution under identical settings, which is how a promising result is confirmed to be a process rather than an accident.
Parallel crystallization platforms for efficient exploration of conditions when material and time are limited.
The reactors are a means to an end: understanding which parameters actually control the outcome.
Solvent system, concentration, cooling or addition profile and seeding strategy are defined from solubility and metastable zone data.
A first controlled execution establishes the reference batch, with all parameters recorded and the product fully characterized.
Cooling rate, agitation, addition rate and seed loading are varied systematically to establish which of them move the outcome and by how much.
Seed form, quantity and addition point are optimised, which is usually what brings polymorphic control and particle size under command.
The chosen conditions are repeated to confirm that form, purity and particle properties are stable across runs.
The design is carried into larger controlled vessels and into the kilo-lab, with the parameters translated rather than simply copied.
Parameters, data and the resulting process description are compiled into the technical-scientific report.
The reactor platforms are supported by in-situ monitoring and by the full solid-state laboratory, so that each run is interpretable.
The output is a reproducible procedure expressed in parameters, together with the data that show it is reproducible.
For a first observation, a flask is fine. For a process, it is not: cooling rate, agitation and addition are uncontrolled and unrecorded, so the result cannot be reliably repeated or transferred. Controlled reactors turn those variables into settings.
Yes. We would execute it under controlled and recorded conditions first, which frequently reveals which uncontrolled variable was responsible for the variability you are seeing.
Where it helps. Seeding is often the most effective way to control which polymorph forms and to narrow the particle size distribution, but it has to be developed — form, loading and addition point all matter, and a badly designed seeding step is worse than none.
Timelines depend on the scope — the complexity of the chemistry, the scale required and how much process development is still needed. We agree the schedule with you before work begins and keep you updated as batches run.
From grams for early development up to kilogram scale in our kilo-lab. We confirm what is achievable for your specific chemistry when we scope the project.
Yes. Our facility is authorized to handle high-potency active pharmaceutical ingredients up to OEB5, and controlled substances under Ministry of Health authorization, under GMP certification issued by AIFA and following FDA inspection.
A detailed technical-scientific report covering the process, the parameters and the analytical results — and, where production is in scope, the synthesized material itself with its characterization data.
Work starts only after a confidentiality agreement is in place. Routes, parameters, data and reports remain yours and are never shared or reused.
Tell us which step refuses to behave the same way twice. We will run it under control and find out why.