Application
Catch the deviation while the batch is still worth saving
Purity is usually confirmed at the end, on a sample, by a method that takes hours. By then the only available decision is accept or discard.
The measurement problem
End-of-batch testing answers a binary question after all the money has been spent. It cannot tell you when the deviation started, which means it cannot tell you what caused it — and a root cause you cannot find is a deviation you will see again.
Continuous composition changes that. An impurity that begins accumulating at a particular point in the run is visible as a feature with a timestamp, next to the process conditions that produced it.
What a live reading changes
- Deviation visible as it develops, with the process conditions alongside it.
- A root cause that has a time on it rather than a hypothesis.
- Reference spectra of the approved material displayed alongside the live measurement — up to three, in SPC format.
- An immutable record of composition through the whole run, not a single certificate at the end.
- A reproducible number in place of a judgement that currently depends on a trained person.
Cleaning validation, measured against HPLC-MS
Cleaning validation is the case where waiting for a laboratory is most expensive: the line stands still until the result comes back. We calibrated the OrionIR® for acetaminophen in methanol from 100 to 5,000 ppm and then measured against a 10 ppm carry-over limit, with HPLC-MS as the reference method.
The mid-IR results agreed with the reference measurements and took a fraction of the time, which makes the method a practical at-line screen — and, for some residues, a replacement for sending the swab out at all.
Is this your measurement?
Send the stream, the concentration range and the decision it blocks. Where it makes sense we test on your own process samples first.