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Neutron Technologies

Technology & capabilities

What we can actually build for you

Not a services menu. This is the work we have done repeatedly, on shipped instruments, in front of regulated customers.

01 — Instrument design

Mechanical, fluidic and enclosure design for cleanroom instruments.

We take an instrument from a written requirement to a manufacturable product: airflow path, sampling head geometry, sealing, sterilisation compatibility and an enclosure that survives a gowned operator handling it in a Grade A zone.

  • Airflow and sampling head design
  • Autoclavable and CIP-compatible assemblies
  • Enclosure design with ingress protection
  • Material selection and MOC documentation
  • Design for manufacture and assembly

02 — Embedded systems

Hardware, firmware and touchscreen software that runs on the instrument.

Custom PCB design through to a running device: STM32 firmware for motor, sensor and flow control, an embedded Linux application layer for the operator interface, and the board bring-up in between.

  • Schematic capture and multilayer PCB layout
  • STM32 firmware — motor control, sensing, Modbus/RS-485
  • Embedded Linux on Compute Module, built with Yocto
  • Qt/QML touchscreen operator interfaces
  • Barcode, QR and Data Matrix scanning
  • Wi-Fi, Ethernet and driverless printing

03 — Compliance software

Server software that turns instrument readings into defensible records.

The part auditors actually open. User management, immutable audit trails, electronic signatures, review workflows and reporting — designed against 21 CFR Part 11 and EU GMP Annex 11 rather than retro-fitted to them.

  • User, role and privilege management with LDAP login
  • Immutable, server-side audit trail
  • Electronic signature and review workflow
  • Dashboards, trending and scheduled reports
  • LIMS and MODA integration
  • Backup, restore and archival

Platform architecture

Four layers, designed together

Read from the bottom up: a flow sensor produces a number, firmware controls the run, the instrument application writes the record, the network carries it, and the site software is where QA signs it off. Any break in that chain is a data integrity finding, so we own the whole chain.

  1. L4 Enterprise

    Site software

    Where QA reviews, approves and reports. Runs on the customer’s server.

    Audit trail E-signature Reports LIMS / MODA
  2. L3 Network

    Connectivity layer

    Instruments reach the server over Wi-Fi or Ethernet, and hold their records if it is unreachable.

    Wi-Fi Ethernet Store-and-forward NTP time sync
  3. L2 Instrument

    Embedded application

    The touchscreen the operator uses, with on-device records and local audit trail.

    Embedded Linux Qt/QML On-device database QR scanning
  4. L1 Control

    Firmware & sensing

    Real-time control of the pump, flow measurement and detection sensing.

    STM32 Mass flow sensing Motor control Modbus/RS-485

Compliance

Designed against the regulation, not around it

The frameworks below are design inputs. They shape the database schema, the login flow and the time source — not just the documentation pack.

21 CFR Part 11 EU GMP Annex 11 GAMP 5 Cat. 4 ALCOA+ GAMP 5

Attributable & original

Every record carries the user who created it and the instrument that produced it. Nothing is written on behalf of a shared login.

Contemporaneous

Timestamps come from a synchronised time source, not the instrument clock an operator can change.

No overwrite

A change creates a new version and an audit trail entry holding the old value and the new one. The original is still there.

Out of reach

The audit trail lives on the server, outside the instrument, so no one operating the device can edit their own history.

Engagement

How a project runs

The sequence matters here, so it is numbered. Each stage produces documents the next one depends on.

  1. 01

    Requirement & design

    URS review, design specification, risk assessment and a traceability matrix that survives an audit.

  2. 02

    Build & verification

    Prototype, design verification testing, EMC and safety pre-compliance, and pilot production.

  3. 03

    Qualification

    IQ, OQ and PQ protocols and execution, with factory and on-site calibration certificates.

  4. 04

    Support & change control

    Release notes, version control, CAPA handling, AMC/CMC contracts and recalibration.

Start with your URS

Send it over and we will come back with what is straightforward, what is hard, and what we would push back on.

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