A crystallization observed only through its final powder is a process you are guessing at. In-situ sensors let us watch nucleation and growth as they happen, and design around what is actually occurring.
Process Analytical Technology sensors give real-time insight into crystallization behaviour — particle size, chemistry, supersaturation and thermal events — enabling data-driven process design and tighter control.
Without them, a crystallization is assessed by its output: a powder at the end, analysed hours later. If the particle size is wrong, or the form is wrong, or the batch will not filter, there is no record of when in the run things went that way. Development becomes trial and error at full batch cost.
In-situ monitoring changes the unit of information from batch to minute. Nucleation onset, growth rate, the effect of a seed addition, the point at which a form transition occurs, the moment supersaturation is exhausted — all become visible while the process runs. Processes designed on that basis transfer better, because the reasoning behind each parameter is documented rather than inferred.
Sensor selection follows the question: what has to be observed in order to control this particular crystallization.
Chord length and particle count tracked through the run, showing nucleation onset, growth, agglomeration and attrition as they occur.
In-line spectroscopic monitoring of concentration and species in solution, which is what makes supersaturation measurable rather than assumed.
The actual trajectory followed through the metastable zone, compared against the one the process was designed to follow.
Heat flow through the run, identifying exotherms, crystallization onset and unexpected transitions.
Direct observation of what a seed addition does — whether it grows, dissolves, or triggers secondary nucleation.
Objective determination of when the crystallization is complete, instead of a fixed hold time chosen for convenience.
Sensors are a development tool first: the aim is to learn enough about the process that it can be controlled with ordinary instrumentation at scale.
We establish what is not understood about the crystallization — variable particle size, inconsistent form, poor filtration — because that determines which sensors are worth deploying.
The existing process is run with sensors in place, producing a time-resolved record of what actually happens.
Nucleation, growth, agglomeration and any transitions are located in time and correlated with the operating parameters.
Changes are made to the parameter the data implicate — cooling profile, seed point, addition rate — rather than to everything at once.
The modified process is run monitored again, confirming that the intended change occurred and produced the intended effect.
The observations are translated into a control strategy that can be executed at scale, with the critical parameters and their limits identified.
Time-resolved data, interpretation and the resulting process design are documented in the technical-scientific report.
In-situ sensors are used alongside the offline solid-state laboratory, since real-time data and definitive characterization answer different questions.
The deliverable is a time-resolved picture of the process, translated into a control strategy you can act on.
No, and that is rather the point. Monitoring is used during development to understand the process; once the critical parameters are known and their limits defined, the process can usually be controlled at scale with conventional instrumentation.
We can reproduce it here under monitored conditions, which is normally the practical route. The time-resolved record usually explains the variability that offline analysis alone could not.
Inconsistent particle size distribution, unexpected polymorph appearance, batches that will not filter, and crystallizations whose behaviour changes on scale-up. All four are much easier to solve when you can see when in the run things diverge.
Timelines depend on the scope — the complexity of the chemistry, the scale required and how much 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 material 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 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.
Describe the behaviour you cannot explain. We will run it monitored and show you when it happens.