Measurement in GMP environments, where the instrument has to be cleanable, calibratable and documented to a standard your validation team can defend.
In a pharmaceutical plant the sensor is part of the qualified facility, not just part of the machine. That changes the specification: surface finish and cleanability come first, then calibration traceability, then the documentation package that supports IQ, OQ and PQ. A sensor that measures well but cannot be documented becomes a deviation.
Our pharmaceutical range is built from the same hygienic platform used in food processing, with additional controls on material certification, surface finish verification and calibration records. Temperature and pressure instruments are supplied with 3.1 material certificates, calibration certificates traceable to national standards, and conformity statements for 3-A and EHEDG design.
For cleanrooms we supply differential pressure sensors for room cascades, and for utilities we supply flow and level instruments for WFI, purified water and clean steam. Signal conditioners with 1,500 V isolation keep the analogue signals clean between the process area and the control system.
Application Reality
These are the failure modes we are called in to solve, and the specification change that addresses each one.
A ribose or lactose residue in a crevice fails a cleaning validation. Flush diaphragms and clamp connections with Ra 0.4 µm remove the geometry that traps product.
Every instrument needs a calibration history that survives an audit. We supply 5-point certificates traceable to national standards and keep the records so a replacement matches the original loop.
Cleanroom differential pressure is a low-range measurement, often 0-50 Pa, where thermal effects and tubing length dominate. Correct sensor placement and short, equal-length impulse lines matter more than the accuracy class.
A missing 3.1 certificate can hold a batch release. Wetted parts are certified per heat number, and the certificate is matched to the instrument serial number.
Replacing a sensor model requires a change control with equivalence evidence. We keep form, fit and function stable and supply a comparability statement when a revision is unavoidable.
Products
DM-SC04-ISO-4CH
DM-MA08-PZ-8UM
DM-TT200-HART
DM-TS100-PT100-4W
DM-PD100-DP-10K
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Standards
| Standard | Requirement |
|---|---|
| GMP / EU GMP Annex 1 | Cleanable, documented, qualified equipment |
| EN 10204 3.1 | Material certificates for wetted parts |
| ISO 9001 + calibration | Traceable calibration records |
| 3-A / EHEDG | Hygienic design conformity |
Application Example
Situation
A sterile fill suite was logging intermittent differential pressure alarms on the grade B corridor, with no identifiable cause in the HVAC system.
What we changed
The existing 0-250 Pa transmitters were replaced with 0-50 Pa low-range units, mounted within 1.5 m of the room tap with equal-length impulse lines, and re-zeroed at each shutdown.
Result
Alarm events fell from several per week to two in six months, and the site added the same configuration to two adjacent suites.
FAQ
Yes. Each instrument ships with a datasheet, material certificates for wetted parts, a calibration certificate and a conformity statement. For IQ/OQ we also supply the installation and operating instructions in a controlled document format, plus a comparability statement if the model replaces an existing one.
Selected stainless models are rated for steam sterilisation at up to 140 °C. The limiting factor is usually the cable and connector, so specify the high-temperature cordset with the sensor; a standard PVC cordset will not survive the cycle.
Typically every 6 or 12 months, defined by your calibration programme and the criticality of the measurement. We supply 5-point certificates so the interval can be justified by data rather than convention.
Ra 0.4 µm as standard, Ra 0.25 µm on request for aseptic duty. The finish is verified and recorded on the inspection certificate, not just claimed on the datasheet.
Yes. We provide a comparability statement covering form, fit, function, materials and performance, plus samples for your own qualification testing before the part is released into production.
Send the application details and get a specification back within one business day.