Planning, construction and service of ultrapure media systems (pure water, pure steam, WFI) for the pharmaceutical industry.
DEWA Engineering und Anlagenbau GmbH
Goslar (Vienenburg)New on Amplifa
About DEWA Engineering und Anlagenbau
DEWA Engineering und Anlagenbau GmbH, based in Goslar (Vienenburg), is a family-run company with more than 30 years of experience in pharmaceutical plant engineering. The company plans, designs, manufactures and qualifies complete ultrapure media supply systems for pharmaceutical production – from water treatment systems (VE water, Aqua Purificata, HPW up to WFI/Water for Injection) and pure steam generators (CSG/CSGE) and multi-column pressurized water distillation systems (DEWADEST) to shell-and-tube heat exchangers with double-tube sheet (DPE/DPU/SW) as well as mixing and pressure vessels. All product-contact parts are made of stainless steel AISI 316L (1.4404) or 1.4301, with surface finishes of Ra < 0.8 µm (electropolished on request) and FDA-compliant sealing materials such as PTFE, EPDM and Viton. The range of services includes planning (URS, risk analysis, P&ID), plant construction, piping with orbital welding and weld seam documentation including endoscopy, FAT/SAT, IQ/OQ qualification as well as maintenance, calibration and 24/7 on-call service. In addition, DEWA conducts research and development, including drinking water production from air and seawater as well as anesthetic gas recycling in hospitals.
- Site
- Goslar
- Processes
- Ultrapure water generation systems (ELRO, water treatment Aqua Purificata), Pure steam generator CSG (steam-heated), Electric pure steam generator CSGE, Mobile pure steam sampling unit, Single-column pressurized water distillation system DEWADEST SC (WFI, up to 50 l/h), Multi-column pressurized water distillation system DEWADEST MC/MCE (3–8 columns, WFI), Shell-and-tube heat exchanger with double-tube sheet (pharmaceutical, DPE/DPU/SW series), Orbital welding / piping with weld seam documentation incl. endoscopy
- Materials
- Stainless steel AISI 316L, Stainless steel 1.4404, Stainless steel 1.4301, Stainless steel AISI 304, PTFE, EPDM, Viton, Mineral wool (insulation)
- Certificates
- GMP/FDA-compliant design, Qualifiable according to pharmacopoeias (USP, PharmEur), Orbital welding with seam documentation and endoscopy
- Industries
- Pharmaceutical industry, Hospitals, Water treatment/drinking water production, Hospitals/anesthetic gas recycling
- 01
Requirements analysis and system planning (URS, risk analysis)
- 02
Design and plant construction
- 03
Piping with weld seam documentation
- 04
FAT and installation
- 05
Commissioning and SAT
- 06
IQ/OQ qualification
- 07
Maintenance, calibration and service
Materials & Surface Finishes
Stainless steel AISI 316L / 1.4404
Material of all product-contact parts in ultrapure water, pure steam and distillation systems with high surface finish.
Stainless steel AISI 304 / 1.4301
Material for non-product-contact system parts such as frames and cladding.
PTFE
FDA-certified sealing material for heat exchangers and vessels.
EPDM
FDA-compliant sterile sealing material, also as crevice-free O-ring seal.
Viton
FDA-certified sealing material for pharmaceutical-grade heat exchangers.
Mineral wool insulation with stainless steel sheet cladding
Thermal insulation of heat exchangers and vessels, welded suitable for cleanrooms.
Locations
Goslar (Vienenburg)
DEHeadquarters, design, plant construction and service
- Materials
- Stainless steel AISI 316L / 1.4404, AISI 304 / 1.4301
- Orbital welding system
- Workshop for plant and piping construction
- Spare parts warehouse
Systems & Components
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Ultrapure water generation systems (ELRO, water treatment Aqua Purificata)Engineering | – | – | – | 30 l/h – several m³/h | Stainless steel AISI 316L |
| Pure steam generator CSG (steam-heated)Engineering | – | – | – | 0 – 100% continuously variable | Stainless steel AISI 316L |
| Electric pure steam generator CSGEEngineering | – | – | – | 0 – 100% continuously variable | Stainless steel AISI 316L |
| Mobile pure steam sampling unitEngineering | – | – | – | – | Stainless steel |
| Single-column pressurized water distillation system DEWADEST SC (WFI, up to 50 l/h)Engineering | – | – | – | 50 l/h | Stainless steel AISI 316L, AISI 304 |
| Multi-column pressurized water distillation system DEWADEST MC/MCE (3–8 columns, WFI)Engineering | – | – | – | 50 l/h | Stainless steel AISI 316L |
| Shell-and-tube heat exchanger with double-tube sheet (pharmaceutical, DPE/DPU/SW series)Joining | Ra < 0.8 µm (on request Ra < 0.5 µm, | – | – | – | Stainless steel AISI 316L |
| Orbital welding / piping with weld seam documentation incl. endoscopyJoining | – | – | – | – | Stainless steel |
| Coil tube cooler SW (WFI cooler, 0.8 m² heat exchanger surface, 38 kW)Engineering | – | 640 mm height × 170 mm diameter | 20 kg | 600 liters/hour (application example) | Stainless steel 1.4404 (316L), 1.4301 |
| Mixing and pressure vessels DAD with agitator for sterile liquidsAssembly | Inner surfaces Ra < 0.8 µm (DLAD | – | – | – | Stainless steel 1.4404, 1.4301 |
| WFI storage and mixing pressure vessel DLAD 100 (100 liters, sterilizable up to 1.9 bar / 130 °C)Assembly | Ra < 0.8 µm | – | – | 100 liters | Stainless steel 1.4404, 1.4301 |
| System planning (requirements analysis, URS, specification of services, detailed design, P&ID,Engineering | – | – | – | – | – |
| Plant construction incl. design, FAT, installation, commissioning, SAT, IQ/OQ qualificationEngineering | – | – | – | – | – |
| After-sales service (maintenance, calibration, repair, 24h on-call service, spare partsAssembly | – | – | – | – | – |
| Drinking water production from air (distillation with rotary vane steam compressor, R&D)Engineering | – | – | – | – | – |
| Vacu Spray – spray/surface evaporation under vacuum (drinking water from seawater/brackish water,Engineering | – | – | – | – | – |
| Electric falling-film steam generation (electric double-jacket heating rod, patented)Engineering | – | – | – | – | – |
| Anesthetic gas recycling (ZeoSys CONTRAfluran, recovery of anesthetic gases)Engineering | – | – | – | – | – |
Additional services
Reference customers
Quality & GMP
The systems are manufactured in accordance with GMP and FDA requirements, qualifiable according to the regulations of the international pharmacopoeias (USP, PharmEur) and documented throughout the project. Testing and safeguarding measures include FAT/SAT, weld seam documentation with endoscopy, dual conductivity monitoring and annual calibration of GMP-relevant measuring instruments.
| Evidence | Goslar (Vienenburg) |
|---|---|
| GMP/FDA-compliant design | |
| Qualifiable according to pharmacopoeias (USP, PharmEur) | |
| Orbital welding with seam documentation and endoscopy |
History
- 1990er
Foundation of the company; more than 30 years of experience in pharmaceutical plant engineering (website states 30, in places 35 years)