Hygienic pressure monitoring in a single-use bioreactor line
Sector: Pharmaceutical & bioprocessing
The challenge
A biopharmaceutical manufacturer was scaling an upstream process from laboratory scale to 2,000 L single-use bioreactors. The new production line required accurate, contamination-free pressure measurement on the media feed, harvest, and transfer lines. Conventional pressure transmitters with diaphragm seals proved too slow to respond, drifted noticeably during CIP/SIP cycles, and required frequent and costly recalibration. On top of that, the new measurement signals had to integrate seamlessly with the existing DeltaV DCS.
The solution
Based on the process conditions and the hygiene requirements (USP Class VI, gamma-irradiated, animal-derived-free), Gommer recommended a combination of sensors from Malema:
- Malema MPT-750 single-use pressure transducers on the bioreactor feed and harvest ports — built directly into the disposable manifold, eliminating any sterile barrier;
- Malema KL-91 and KL-92 compact sanitary pressure transducers with Tri-Clamp connections on the re-usable lines, calibrated for 0–6 bar with a 4–20 mA HART output;
- Malema KL-95 for the higher pressure range on the tangential flow filtration (TFF) skid.
Sensors were supplied with factory calibration and 3.1 material certificates, complete with the required cabling. The signal configuration was aligned in advance with the customer’s DCS integrator.
The result
The single-use design eliminates the risk of cross-contamination between batches and has reduced changeover time between runs by approximately forty percent. The HART integration enables continuous diagnostics, so deviations are detected at an early stage. The QA team reports a measurably more stable process across consecutive batches.
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