Pharmaceutical Stainless Steel Equipment: GMP‑Compliant Process Tanks, Blenders and Pipework
Request a quoteStainless steel pharmaceutical fabrication is at the core of what Stainless Tank & Mix has been designing, engineering and manufacturing for the pharmaceutical industry for over 50 years. Based in Sydney, our team understands the strict hygiene, material, documentation and manufacturing requirements that apply to pharmaceutical processing environments.
STM uses this long history of working within the pharmaceutical industry to design and manufacture equipment in accordance with the Therapeutic Goods Administration’s (TGA) Code of Good Manufacturing Practice (GMP). Every project is developed around the process, product and operating conditions, from material selection and surface finish through to fabrication and documentation.
Our Sydney workshop manufactures a range of pharmaceutical equipment and stainless steel solutions, including process tanks and jacketed vessels, IBC mixers, powder blending equipment, vacuum transfer systems, pipework, ductwork and CIP systems. Whether you need a single piece of process equipment or a more integrated fabrication solution, STM can engineer and manufacture it to suit your pharmaceutical production requirements.
Pharmaceutical jobs are usually small and heavily specified, and the paperwork matters as much as the welds. We work through the finish, the materials and the documentation with you before any steel is cut, so what arrives on site is ready for validation.
Pharmaceutical Equipment We Design and Build
Process tanks and jacketed vessels
STM designs and fabricates custom pharmaceutical process tanks and jacketed vessels to suit specific production requirements. Built for applications involving controlled heating, cooling and mixing, these vessels can be configured around your process, product characteristics and operating conditions. Options include jacketed construction for temperature control and integrated agitation for consistent mixing. STM works with pharmaceutical manufacturers to develop practical stainless steel equipment that supports production efficiency, cleanability, and relevant industry requirements. Explore our range of process tanks and vessels to learn more.
Learn more ›Powder blending and contained transfer
STM manufactures custom pharmaceutical powder blending equipment to meet specific production requirements, including IBC mixers, vacuum transfer systems, and ribbon blenders. Each system can be built around your process, material handling needs and batch requirements. For a multinational pharmaceutical manufacturer, STM custom-fabricated an IBC mixer with IBCs to support powder processing. From blending equipment to contained transfer systems, STM works with manufacturers to develop practical equipment configurations suited to their production processes. In contained transfer, all the powder and its dust stays enclosed in pipework, ducts or chutes, often with flexible connections at one or both ends, which matters when the dust is harmful.
Learn more ›Magnetic-drive and hygienic mixers
Magnetic-drive and hygienic mixers for the pharmaceutical industry must meet stringent hygiene, cleanability and contamination control requirements. STM is the Australasian representative for MagMix, the UK maker of magnetic drive mixers, and designs and fabricates hygienic mixers tailored to specific pharmaceutical processes, product characteristics and production needs. With a focus on hygienic design, fabrication quality and reliable performance, each mixer is engineered to support consistent processing and the demanding standards of pharmaceutical manufacturing.
Learn more ›Sanitary pipework and ductwork
STM fabricates and installs purge-welded stainless steel pipework and ductwork for pharmaceutical manufacturing facilities. Our ductwork capabilities include square-to-round transitions, cones, lobster-back bends, tapered bends, cyclones, spirals, breech pieces, and hoods. For sanitary pipework, we understand the requirements of pharmaceutical processing, including hygienic fittings, valves, flow meters, pipe spools, valve matrices, and key stations. Each system is fabricated to suit specific process requirements, supporting hygienic operation, efficient material transfer, and reliable performance in pharmaceutical production environments.
Learn more ›CIP and cleaning
Clean-in-place (CIP) systems are incorporated into STM’s pharmaceutical equipment designs to support effective cleaning, hygiene and operator safety. These systems allow equipment to be cleaned without disassembly, reducing manual handling and simplifying routine cleaning procedures.
Learn more ›What GMP Means for Stainless Steel Equipment
Good Manufacturing Practices (GMP) for stainless steel equipment involve designing, fabricating and maintaining equipment to minimise contamination risks, support effective cleaning and protect product quality and safety in regulated industries such as pharmaceuticals.
GMP equipment design considers material selection, surface finish, weld quality, drainage, and cleanability. Stainless steel grade 316L is commonly used in pharmaceutical applications due to its corrosion resistance and suitability for hygienic processing. A surface finish of ≤0.5 Ra helps minimise areas where product residues and contaminants can accumulate, with electropolishing available through a specialist supplier where specified.
Crevice-free construction, hygienic welds, drainable vessel designs and Tri-Clamp fittings support effective cleaning and reduce potential contamination points. Equipment can also be designed for clean-in-place (CIP) and steam- or sterilise-in-place (SIP) processes, depending on the application and cleaning requirements.
What are the key GMP design factors for stainless steel pharmaceutical equipment?
| GMP design factor | What it means for the equipment |
|---|---|
| Material selection | Suitable stainless steel grades, supported by material certificates, and suitable elastomers (the non-metal gaskets and seals) with traceability. |
| Surface finish | Specified internal finishes, with electropolishing where required. |
| Hygienic design | Crevice-free surfaces, drainable construction and hygienic welds. |
| Cleaning compatibility | CIP/SIP provisions and suitable fittings. |
| Documentation | Material certificates, weld maps, passivation records and factory acceptance testing (FAT). |
| Qualification support | Documentation to assist in installation qualification (IQ) and operational qualification (OQ). |
STM designs and manufactures stainless steel process equipment for pharmaceutical applications, with materials, finishes, hygienic features and documentation tailored to each project’s needs. Relevant quality certifications and supporting documentation help demonstrate compliance with applicable standards and project specifications.
GMP-compliant stainless steel equipment is built so that product-contact surfaces cannot harbour residue, every material is traceable, and the equipment can be validated. Stainless Tank & Mix designs pharmaceutical vessels and systems to these requirements:
- 316L stainless steel for product-contact surfaces, with electropolishing through a specialist supplier where specified
- Internal finish to ≤0.5 Ra µm, verified and recorded before delivery
- Crevice-free, fully drainable design with no dead legs, sloped bottoms and low-point outlets
- Hygienic welds ground and polished flush, with weld maps identifying every joint
- Sanitary fittings (Tri-Clamp) and CIP/SIP-compatible layouts
- Documentation for validation: material test certificates, weld procedure records, passivation certificates and factory acceptance test reports
- Design to TGA GMP requirements, with drawings and P&IDs supplied for your IQ/OQ
The result is equipment that is ready for audit and can be cleaned and validated on a repeatable cycle.
Pharmaceutical Projects
STM has designed and manufactured custom stainless steel equipment for pharmaceutical manufacturers, with solutions tailored to specific production, handling and hygiene requirements. Projects range from mixing systems to material transfer and lifting equipment.
For a multinational pharmaceutical company, STM designed an IBC mixer with IBCs to address increasing batch sizes and fatigue in the existing mixer. The replacement unit maintained the original dimensions to fit the existing mixing room while incorporating full stainless steel cladding and a concealed tilting mechanism. Large removable covers also provide convenient access for maintenance.
STM also developed an equipment lifter for a vacuum transfer unit, designed to lift the transfer equipment above an IBC for filling. The solution needed sufficient lifting capacity and reach, efficient operation and a low overall height to access multiple filling rooms. A clean, practical design with wheels also made the unit easier to manoeuvre between work areas.
Other pharmaceutical projects include 100 L and 160 L heated mixing tanks, designed for controlled heating and mixing of process materials.
These projects demonstrate STM’s ability to engineer equipment around existing facilities, production demands, and practical operating requirements, with functionality, maintenance access, and hygienic design considered throughout the process.
From Concept to Validation
STM provides turnkey stainless steel equipment solutions for pharmaceutical manufacturers, managing each stage from initial design and engineering through to fabrication, installation and commissioning.
The process begins with detailed engineering using 3D CAD modelling to visualise equipment and assess how it will fit within existing facilities. Piping and Instrumentation Diagrams (P&IDs) map process connections and instrumentation, while Finite Element Analysis (FEA) can be used to assess structural performance where required. Computational fluid dynamics (CFD) is also used to design and validate mixing inside a vessel and in other applications. It simulates how liquids and gases flow within set boundary conditions, shows where turbulence occurs, and works out the power a mixer needs once the product’s viscosity and density are known.
Once the design is finalised, equipment is fabricated at STM’s workshop in Minto, Sydney. Factory acceptance testing (FAT) allows equipment to be inspected and tested before delivery, helping confirm it meets the agreed project specifications.
STM can also coordinate installation and commissioning, providing supporting documentation to assist with qualification and validation activities, including installation qualification and operational qualification.
From initial concept to final handover, STM considers process requirements, equipment integration and documentation to help pharmaceutical manufacturers bring new equipment into their facilities.
Our Process
Concept
Understanding the brief and building a thorough scope
Design
Engineering, 3D modelling, and design approval
Fabrication
Precision manufacturing with full traceability
QA
Inspection, testing, and quality assurance
Installation
On-site assembly and integration of equipment
Commissioning & Handover
Ensuring performance and customer sign-off
Frequently Asked Questions
What surface finish is required for pharmaceutical stainless steel tanks?
The required surface finish depends on the product, cleaning process, and applicable specifications. A finish of ≤0.5 µm Ra is commonly specified for pharmaceutical applications to support hygienic processing and cleanability. A lower Ra can be achieved by mechanical polishing, and electropolishing can be requested where a smoother surface is needed.
Do you supply documentation for GMP validation?
STM can provide project-specific documentation to support equipment qualification and validation activities. Depending on the project, this may include material certificates, weld maps, passivation records, factory acceptance testing (FAT) documentation and information to assist in installation qualification (IQ) and operational qualification (OQ).
Can you build equipment from 316L stainless steel and electropolish it?
Yes. STM manufactures stainless steel equipment to specified material and surface finish requirements, including 316L stainless steel and electropolishing, through a specialist supplier, where required. These specifications can be incorporated into the equipment design and fabrication process.
Do you make IBC mixers and contained powder transfer systems?
STM designs and manufactures pharmaceutical mixing and material handling equipment, including IBC mixers, vacuum transfer units and powder handling solutions. Equipment can be tailored to batch sizes, production workflows, available space and cleaning requirements, helping integrate new systems into existing facilities.
Talk to Our Engineers
STM designs and fabricates pharmaceutical equipment around your project needs, from IBC mixers to equipment lifters, vacuum transfer units and heated mixing tanks.
With turnkey solutions, our experienced team can assist at all stages of your project, from initial design and engineering through fabrication, installation and commissioning. Speak to our team today about an end-to-end solution tailored to your site and process.
