Client Background & Pain Points
A pharmaceutical company expanded an aseptic production line in Catalonia, northeast Spain, requiring clean process and utility valves: a sanitary valves package for a pharmaceutical plant in Spain. The client was a European pharmaceutical company and the engineering was carried out by a local engineering firm. The project had to comply with EU good manufacturing practice for sterile products and the relevant pharmacopoeia requirements, covering water-for-injection and clean-steam systems; clean components needed traceable material certificates and surface-roughness control; and the EU pressure equipment directive sets clear requirements on compliance documentation for pressure-retaining parts.
Scope of Supply: Sanitary Valves for the Pharmaceutical Plant in Spain
Sanitary diaphragm valves (DN15–DN80), valves for clean steam and pressure reduction, aseptic ball valves and sampling valves, plus globe and check valves for utilities; materials mainly 316L with electropolishing, and diaphragms in elastomers meeting pharmacopoeia requirements — approximately 210 units in total.
Implementation: Sanitary Valves for a Pharmaceutical Plant in Spain
After award came the document confirmation stage, centred on material certificates, surface-roughness reports and compliance declarations. We provided a complete traceability file set as required, and the clean components were surface-finished by electropolishing. One difficulty arose when the clean-system piping was locally adjusted during construction, requiring changes to the installation orientation and connections at some sampling points, while the European summer holiday was approaching and local response slowed. We proposed a change approach of “no change to valve body structure, only adjustment of connectors and matching fittings,” which shortened the re-confirmation cycle. Manufacturing and testing proceeded in sequence, with clean components cleaned and packaged separately to avoid contamination. Delivery was in three batches with a document package; after installation we supported the data records needed for commissioning.
Delivery Outcome & Post-delivery Support
From award to equipment arrival took about six months. System commissioning progressed on schedule, and the clean-line valves showed no leakage or particle-risk events in operation. The client set up a periodic inspection and spare-replacement plan, and we provide one remote technical support session annually.
Lessons Learned
In pharmaceutical projects, documentation and cleanliness weigh more than the product alone. First, traceable material documents, surface treatment and compliance declarations must be confirmed before scheduling to avoid retrofitting after arrival. Second, for construction-phase changes, an approach of “change connections, not the main structure” shortens the re-validation cycle. Third, cleaning and packaging of clean components should be managed as a separate operation to prevent transport contamination.
ASTM A182 forged flanges and fittings https://www.astm.org/a0182_a0182m-21.html
ASME B16.34 valve standard https://www.asme.org/codes-standards/find-codes-standards/b16-34-valves-flanged-threaded-welding-end
