Stainless steel welding solutions for the medical and biotechnology industries
Medical technology and biotechnology have particularly high hygiene standards. Errors can have far-reaching consequences. Therefore, welds in sterile production facilities must also reliably meet these requirements.
As a certified welding company and EHEDG member, STW supports businesses with tailor-made stainless steel welding solutions for medical technology and biotechnology applications. From piping components and assemblies to precision laser-cut parts, solutions are created that are manufactured with exacting accuracy, traceable documentation, and designed for audit processes.
Do you need a welding solution in the medical or biotechnology industry?
These are the requirements that welds must meet in sterile processes.
Production facilities in medical technology and biotechnology come into direct contact with sterile media, active ingredients, nutrient solutions, or diagnostic substances. Therefore, every weld in this environment must meet three requirements simultaneously:
Sterility
Pores, cracks, crevices, or rough surfaces are not simply quality defects in sterile processes, but represent an immediate contamination risk. Product-contacting seams must be smooth, free of pores, and fully welded.
Cleanability
Systems are cleaned and sterilized while installed. CIP (Cleaning in Place) is performed using aggressive cleaning agents, while SIP (Sterilization in Place) uses steam at temperatures up to 140 °C. This requires properly executed seams without any excess material and surfaces that can be completely wetted and rinsed.
traceability
In regulated environments, a weld without documentation is not auditable. Welding parameters, material certificates, test reports, and welder qualifications must be fully available to meet internal audits, regulatory requirements, and approval procedures.
The standards framework: What applies to suppliers in the medical technology sector
DIN EN ISO 3834-2 This standard regulates the quality requirements for fusion welding, from planning to documentation. STW is certified according to this standard.
EHEDG STW defines the European hygiene standard for facilities with high hygiene requirements. STW is a member of EHEDG and actively participates in developing guidelines.
GMP describes the guidelines for drug production and requires documentable processes and complete traceability.
AD 2000 leaflet HP 0 / HP 100 R This applies to pressure-bearing pipelines and tanks. STW is certified accordingly.
ASME BPE specifies requirements for weld quality and surfaces for bioprocess plants.
STW services for medical technology and biotechnology
Orbitally welded piping components
Orbital welding is the preferred method for pipe connections in medical technology and sterile production environments. The welding head moves fully automatically in a circular motion around the pipe using pre-programmed parameters. Each weld is produced reproducibly, and all parameters are recorded without gaps. The result is uniform, discoloration-reduced, and pore-free welds with high repeatability.
STW uses orbital welding systems with closed welding jaws for pipe diameters up to 168,3 mm. The standard material used is 1.4404 (316L), a proven stainless steel for hygiene-critical and wetted applications. We also manufacture from 1.4435 upon request.
TIG-welded assemblies and components
For assemblies, housing components, connectors, and all geometries that preclude pipe welding, manual TIG welding by qualified personnel is the ideal 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 that could impair the quality of the weld.
Laser-cut parts and sheet metal assemblies made of stainless steel
We manufacture custom laser-cut stainless steel parts for housings, brackets, covers, and structural components in medical devices and laboratory equipment. Production is available for both individual and series production, precisely according to your drawings in DXF, DWG, or STEP format. Our fiber flatbed laser processes sheet metal up to 3.000 × 1.500 mm with material thicknesses from 0,5 to 20 mm.
Why medical technology manufacturers work with STW
1. Documentation that will pass your audits
Welding procedure specifications (WPS), welder qualifications according to DIN EN ISO 9606-1, material certificates, endoscopy results, roughness measurements and, in the case of orbital welding, complete welding parameter protocols are provided in a complete package that is accepted by your quality assurance department.
2. Certifications that count
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 meet the requirements that medical device manufacturers place on their welding suppliers.
3. Check before problems arise
STW uses endoscopes up to 7,5 meters long for the internal inspection of welds. In addition, residual oxygen measurements are taken before and during the welding process, along with ferrite measurements and tests using calibrated surface roughness measuring devices. Even non-visible properties are recorded and documented in a traceable manner.
4. Material traceability is ensured.
Stainless steel grades 1.4301 for square bars and 1.4404 for round tubes are permanently available. All materials are supplied with complete material certificates upon request; other grades are available upon request.
5. All services come from a single source.
Laser cutting, bending, welding, quality control and documentation are all carried out at STW in Nördlingen. This eliminates intermediate logistics and additional coordination efforts between multiple suppliers.
Welding solutions for the medical and biotechnology industries from a single source
In medical and biotechnology, the quality of the weld determines the safety and functionality of the entire system. Hygienic execution, reproducible processes, and complete documentation are not additional requirements, but rather prerequisites for operation and auditability.
STW combines many years of experience in stainless steel plant construction with the certifications, processes, and testing methods required in regulated environments. Whether orbitally welded pipelines, TIG-welded assemblies, or precision laser-cut parts: you receive components that are technically impressive, manufactured in accordance with standards, and delivered with the necessary documentation.
Are you looking for a qualified welding supplier for your medical technology or biotechnology plant?
FAQ
ISO 13485 is the standard for the quality management system of medical device manufacturers. As a welding service provider and supplier, STW is certified according to DIN EN ISO 3834-2 – the recognized standard for quality requirements in fusion welding. This is complemented by EHEDG membership and certification according to AD 2000-Merkblatt HP 0. This combination demonstrates the expertise, process quality, and documentation capabilities that your quality assurance requires.
Standard materials are 1.4301 and 1.4404 (316L) – the latter being the standard material for product-contacting piping and assemblies in medical technology. We also manufacture from 1.4435 upon request. All materials are supplied with complete material certificates.
Yes. We provide welding procedure specifications (WPS), welder qualifications, material certificates, test reports, roughness measurements, and – for orbital welding – complete welding parameter protocols. Contact us if you have specific documentation requirements – we'll tailor the package accordingly.
Both. We manufacture individual pieces for prototypes and pilot plants as well as small series for ongoing production. For laser-cut parts, we can provide a quick quote; for complex assemblies, we coordinate deadlines individually.
Yes. If required, our assembly team will install piping systems directly in your production facility – nationwide and internationally.
Get advice now!