Welding for the pharmaceutical industry: Precision that knows no compromises
No industry places higher demands on welded joints than pharmaceutical production, where sterile conditions are of paramount importance. Every weld in a GMP-regulated facility must not only be leak-proof and resilient, but also hygienic, cleanable, and fully documented.
STW GmbH is a certified welding company and a member of the EHEDG. We supply stainless steel welding solutions for the pharmaceutical industry that meet the industry's high standards – precisely manufactured and fully documented.
We would be happy to advise you on your options.
Special requirements for welds in pharmaceutical production
In pharmaceutical production, active ingredients, injectable solutions, vaccines, and sterile media are transported through piping systems, processed in containers, and controlled via valve combinations. Every weld that comes into contact with these media represents a potential weak point, not only from a technical perspective but also from a regulatory standpoint.
Dead spaces in piping systems, poorly executed connections, or rough seam surfaces offer ideal growth conditions for germs. This can result in microbiological contamination of the product stream, which in pharmaceutical production has direct consequences for production safety, as well as regulatory status and inspections.
For every weld in pharmaceutical production, three key requirements apply simultaneously:
Sterility
Pores, cracks, fissures, or rough surfaces in GMP facilities are not merely quality defects, but represent a concrete contamination risk. For product-contacting pipelines and containers, a recognized guideline value of Ra ≤ 0,8 µm applies in pharmaceutical plant construction; this is measured and documented as part of the plant qualification process. In sterile areas, Ra ≤ 0,5 µm is often required.
Cleanability
CIP (Cleaning in Place) and SIP (Sterilization in Place) with steam at temperatures up to 140 °C are standard in pharmaceutical plants. Welds must be free of dead spaces and completely drainable so that cleaning media can reach all areas and product residues are reliably removed.
traceability
As part of GMP qualification, installation, operational, and performance qualification (IQ/OQ/PQ), it is demonstrated that all plant components have been installed according to the design specifications and are functioning correctly. Welds without complete documentation are considered ineligible for inspection during regulatory audits and inspections.
Request a free initial consultation now!
The standards and regulations for welding suppliers in the pharmaceutical industry
GMP (Good Manufacturing Practice) These are the European guidelines for pharmaceutical production. Plant manufacturers and component producers are indirectly affected: Anyone supplying components or pipe sections for pharmaceutical production plants must create the conditions for GMP-compliant processes. This includes validatable welding processes, complete material documentation, and reproducible weld quality.
DIN EN ISO 3834-2 This standard defines comprehensive quality requirements for fusion welding – from process planning and welder qualification to complete documentation. STW is certified according to this standard.
The EHEDG (European Hygienic Engineering & Design Group) STW sets standards for hygienic plant design: weld preparation and execution, weld quality, and complete cleanability. STW is a member of the EHEDG.
The AD 2000 information sheet HP 0 / HP 100 R This applies to pressure-bearing pipelines and tanks. STW is certified according to HP 0 and HP 100 R – relevant wherever process media are under pressure.
EN 10204 This regulates acceptance test certificates for metallic products. In the pharmaceutical industry, material certificates according to section 3.1 are generally required for stainless steel components. These certificates document the chemical composition and mechanical properties with complete traceability back to the melt. The necessary documents can be supplied as part of the documentation requirements.
The ASME BPE (Bioprocessing Equipment Standard) This standard describes requirements for weld quality and surface finish in bioprocess plants, particularly for international and US approvals. If your customers or authorities test according to this standard, please indicate this in your initial inquiry.
STW services for the pharmaceutical industry
Orbitally welded piping components
Orbital welding is the leading method for pipe joints in the pharmaceutical industry. The welding head moves fully automatically in a circular motion around the pipe using precisely pre-programmed parameters. Each weld is identical to the previous one in terms of execution parameters. All settings, such as current, voltage, welding speed, and gas flow, are recorded without gaps and made available for qualification documentation.
The result is uniform, low-tarnish, and pore-free welds without any bulges or sagging. STW uses orbital welding systems with closed welding jaws for all common pipe diameters. The standard material used is 1.4404 (316L), which is recognized as a standard for product-contact piping in the pharmaceutical industry.
TIG manual welding for special geometries and outdoor assembly
Not every joint in a pharmaceutical plant can be orbitally welded. For complex component geometries, hard-to-reach positions, or directly within operating production lines, manual TIG welding by qualified personnel is the appropriate solution. Shielding gas protects the weld zone from oxidation, while forming gas additionally protects the inside of the pipe. This preserves the passive layer of the stainless steel and minimizes discoloration.
STW's external installation team can, if required, install piping systems directly in your production facility – nationwide and internationally, with the same level of documentation as in factory production.
Sheet metal assemblies and laser-cut parts made of stainless steel
For housings, brackets, panels, and structural components in pharmaceutical plants, we manufacture custom laser-cut parts and sheet metal assemblies from stainless steel – precisely according to your drawings in DXF, DWG, or STEP format. Our fiber flatbed laser processes sheet metal panels up to 3.000 × 1.500 mm with material thicknesses from 0,5 to 20 mm.
Quality, testing and documentation from a single source
At STW, you receive audit-proof documentation. This includes welding procedure specifications (WPS), welder qualifications according to DIN EN ISO 9606-1, material certificates, endoscopy results and roughness measurements, as well as complete welding parameter protocols for orbital welding. All documents are provided in a comprehensive package that meets the requirements of your quality assurance and regulatory authorities.
Before commissioning your system, we conduct comprehensive tests. Using endoscopes up to 7,5 meters long, we inspect welds from the inside, measure residual oxygen before and during the welding process, and check surface roughness with calibrated measuring instruments.
STW is certified according to DIN EN ISO 3834-2, EN 1090-1, EN 1090-2 and AD 2000-Merkblatt HP 0 and is a member of the EHEDG. These certifications form the basis for the seamless integration of our components into your qualification documentation.
We maintain a permanent supply of materials 1.4301 and 1.4404 for manufacturing. Upon request, we can provide all materials with the corresponding material certificates. Other grades are available upon request.
All services are provided from a single source: laser cutting, bending, welding, quality control and documentation are all bundled at STW in Nördlingen. This eliminates interfaces, intermediate logistics and additional coordination efforts.
Are you planning a new pharmaceutical plant, looking for a qualified supplier for ongoing manufacturing orders, or do you need support with documentation for GMP qualification?
FAQ
GMP is not a certification standard for suppliers, but a regulatory framework for pharmaceutical manufacturers. We manufacture in compliance with GMP, using validated, documented processes and complete material traceability. Our certifications and EHEDG membership demonstrate the required process quality.
Yes, we provide all relevant documents such as WPS, welder qualifications, material certificates, and test reports. We can also compile the documentation individually according to customer or qualification requirements.
1.4404 (AISI 316L) is the standard for product-contacting components in the pharmaceutical industry. The material is corrosion-resistant, readily weldable, and permanently available from STW.
Yes, our installation team installs piping systems directly on site. The documentation meets the standards of factory production.
We typically deliver laser-cut parts and sheet metal assemblies on short notice. For piping components, we coordinate delivery dates individually to ensure the necessary level of testing and documentation.
Get advice now!