Pharmaceutical fabrication: where traceability is mandatory
The pharmaceutical and biotechnology industry is the sector with the strictest boilermaking requirements: materials with 3.1 certification, traceability of every weld, surface finishes verified with a roughness tester, GMP documentation and IQ/OQ qualification procedures.
At Talleres ECI we work to ASME BPE and EHEDG standards and EMA GMP guidelines, ensuring that every piece of equipment we manufacture can be fully documented for the client plant's validation processes.
All the stainless steel material we use in product contact —AISI 304, AISI 316L and other special alloys— carries an EN 10204 type 3.1 certificate with chemical and mechanical analysis. Welding gases are of pharmaceutical grade and the orbital welding process is validated for WFI and product piping.
Equipment we manufacture for pharma
- Preparation and storage tanks
- Bioreactors and fermenters
- Sanitary pipework systems (WFI, product)
- Orbital welding of stainless steel piping
- Sanitary shell-and-tube heat exchangers
- Tanks with steam / hot water heating
- Stainless steel structures for cleanrooms
- Modifications and extensions of GMP installations
- Spare parts with full traceability
- IQ/OQ documentation for manufactured equipment
Standards we apply
ASME BPE
Design and fabrication in line with the ASME Bioprocessing Equipment standard for piping and equipment in contact with pharmaceutical product.
GMP / EMA
Documentation in line with Good Manufacturing Practice: material traceability, welding records, qualification protocol.
Ra ≤ 0.4 µm
Interior finishes verified with a calibrated roughness tester. Electropolishing available for the strictest cleanliness requirements.
Pharmaceutical boilermaking
Yes. We deliver a complete manufacturing dossier that includes: EN 10204 type 3.1 material certificates, welding records (WPS/PQR/WPAR), dimensional control records, roughness measurements with a calibrated roughness tester, hydraulic or pneumatic test protocol, and a component list with traceability. This dossier serves as the basis for the client's IQ protocol.
Yes. We have orbital TIG welding equipment for installing sanitary piping in 316L grade for WFI (water for injection), purified water and product lines. Each orbital weld is recorded with the programme parameters and visual inspection of the internal bead by endoscopy where the diameter allows it.
Yes, following the access and work procedures the client establishes for each classified area. Our staff are trained in hygiene and behaviour requirements for GMP environments. For work in active zones, we coordinate the intervention planning with the production and quality manager.