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Stainless steel manufacturing for pharmaceutical & process technology

When cleanability, surface and documentation are part of the design: we make customer-specific components, vessels and assemblies in stainless steel to drawing and specification – from the one-off to the small batch.
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Segregated production · pressure and process vessels · qualified welding · defined surfaces · documented manufacturing

What matters in pharmaceutical & process technology

Pharmaceutical work begins not with a certificate but with the detail.

In pharmaceutical and process applications it is not enough that a part is made to size and cleanly welded. Material, surface condition, design detail, weld execution, cleanability and documentation all have to match. EU GMP requires plant and equipment to be suitable for the intended process and built so that effective cleaning and maintenance are possible and the risk of cross-contamination is minimised – and for sterile processes, design, qualification, validation and contamination control are linked still more closely. For manufacturing that means:

Material and material handling

What counts is not “stainless steel” in general but the grade specified and the traceable way it is processed. Different applications call for different austenitic grades, certificates and scopes of documentation – the customer’s specification governs. At stainlesstec, stainless steel work is kept separate from ordinary structural steel: the risks of rust marks and contamination are thus reduced while the part is still being made.

Cleanability and design detail

A hygienically demanding design should as far as possible create no areas where product residues or cleaning media can lodge permanently. Typical points are:

  • transitions and radii
  • crevices and undercuts
  • connections and nozzles
  • complete drainability
  • accessibility for cleaning
  • internal geometries of vessels
  • the execution of product-contact welds

For us that means we do not read a drawing geometrically alone. Where requirements for cleaning, surface or weld execution are defined, they are taken into account in production planning and in the sequence of work.

The surface is more than a grit size

In pharmaceutical and hygienic-design applications a defined Ra value is often required. A low Ra value on its own does not describe a surface fully, though: different processes can produce different topographies at similar roughness values. Work along ASME BPE lines, for instance, uses surface designations in the region of Ra ≤ 0.51 µm mechanically finished or Ra ≤ 0.38 µm electropolished – but these are not blanket GMP limits; the surface needed follows from the application and the specification. Before production starts it should therefore be clear: what surface is required? Where does it apply? How will it be verified? What post-treatment is intended? stainlesstec manufactures to these defined requirements and settles surface questions at the project review stage.

Welds become functional surfaces

In product-contact areas a weld is not merely a mechanical joint: it has to meet requirements for strength, geometry, cleanability, surface quality, corrosion resistance and documentation all at once. That takes more than a suitable process – it takes experienced specialist welders, a considered welding sequence and controlled dressing. This is exactly where craft welding skill combined with data-driven manufacturing shows its strength.

Typical components for pharmaceutical & process technology

Process and agitated vessels

Customer-specific vessels with connections, nozzles, internals, agitator mountings or heating and cooling functions.

Pressure vessels

Pressure-bearing components and vessels to the technical and documentary requirements agreed in each case.

Filter housings

Individually made housings with defined connections, surfaces and design interfaces.

Sieves, sieve frames & filter components

Strainer baskets, metal frames, perforated plate and mesh structures, and complete filter assemblies.

Hoppers and transitions

Round, rectangular or bespoke geometries for dosing, filling and process applications.

Vacuum and heat exchanger components

Components to customer data for vacuum, heating or cooling duties.

From CAD data set to documented part

1

Settle the requirements

Drawing revision, material, surface, tolerances, welding requirements, testing and documentation are settled before production begins.
2

Prepare production

CAD and customer data are translated into manufacturing data, work sequences and test requirements.
3

Build under control

Laser cutting, punching, forming, welding, surface finishing and assembly are coordinated with one another.
4

Test

Depending on the order: dimensional, surface, pressure, tightness or other agreed tests.
5

Document

The agreed material, manufacturing and test records are allocated unambiguously to the project.

That follows the logic of regulatory qualification: EU GMP Annex 15 distinguishes design, installation, operational and performance qualification and requires, among other things, that design documents and materials be verified. stainlesstec provides the manufacturing-related prerequisites and records within the agreed scope – GMP qualification of the plant as a whole remains with the responsible plant manufacturer or operator.

Are you planning a pharmaceutical or process component?

We can assess feasibility fastest if you give us the following:

  • drawing / STEP / DXF
  • material and material standard
  • quantity or lot size
  • product-contact areas
  • the Ra value wanted
  • surface treatment
  • welding requirements
  • operating pressure and temperature, where relevant
  • CIP/SIP requirements, where relevant
  • the tests required
  • the material and manufacturing documentation needed
Have your project reviewed

Why stainlesstec?

Controlled stainless steel manufacturing

Our materials and our shop are set up for high-grade stainless steel and aluminium work – segregated production, no carbon steel.

Specialists at the weld

Demanding welded joints are not mastered by the machine alone but by people who understand material, heat and distortion.

From single part to assembly

We join up several operations and so cut the interfaces at your end.

Quality that can be documented

In regulated applications it is not only the finished part that counts but a traceable account of how it came about.

Let’s talk about your project.

Send us your drawing or CAD data by email – together with material, batch size and your requirements. We will come back to you with a sound assessment.

Send an enquiry by email

or write directly to info@stainlesstec.de – simply attach your drawing, STEP or DXF file.

DIRECT LINE: +49 5121 690 85-0