A workshop, not a catalogue

Neutron Technologies was established in 2019 to build a microbial air sampler that Indian pharmaceutical manufacturers could put in front of an inspector without apologising for it. At the time the choice was between imported instruments that cost a great deal and were slow to support, and local instruments that were affordable and quietly failed audit trail review.

We took the harder route: design the mechanics, write the firmware, write the server software, and treat 21 CFR Part 11 as a design input rather than a compliance claim added at the end. That meant learning three disciplines properly instead of buying two of them in — and it is why the audit trail on our instruments is server-side and immutable rather than a log file on the device.

The range grew from there: a standalone entry model, a memory model that holds its own records, a fully networked CFR model, and the Neutro BCMS and Neutro EMS software behind them. Along the way we filed two patent applications on the detection problem nobody else was solving.