PSG (Pure Steam Generator)
Pharma Engineers Pure Steam Generators are cGMP-compliant systems designed for sterile pharmaceutical applications. They produce high-purity steam meeting global WFI pharmacopoeial standards, ensuring contamination-free sterilization and reliable performance in critical processes.
cGMP-Compliant Solution for Pharmaceutical Applications
As per cGMP requirements, it is recommended to use Pure Steam in place of filtered plant (black) steam. Pure steam is used for in-situ sterilization of vessels, piping distribution systems, autoclaves, and for humidification of sterile rooms. This prevents contamination from particulate matter, organic impurities, and biological loads such as pyrogens, which are unavoidable in plant steam.
Pharma Engineers manufactures Pure Steam Generators designed to fully comply with cGMP requirements. The condensate of the generated pure steam meets all pharmacopoeial requirements of WFI, including USP, IP, BP, and JP. The plant is manufactured in accordance with FDA current Good Manufacturing Practices (cGMP) and ASME requirements.
Pure steam generated from this equipment surpasses standard steam quality tests such as non-condensable gases, degree of superheat, and saturation tests. Pharma Engineers has developed an improved design to effectively remove non-condensable gases before pure steam generation.
Principle of Operation
The system operates on the principle of Thin Film Distillation by Falling Film Evaporation. It consists of shell-and-tube heat exchangers where heat transfer occurs through falling film evaporation. This ensures:
- High temperature exposure for every drop of water
- Reliable sterilization
- Effective separation of pyrogenic load through centrifugal action during upward steam movement
Hygienic Design & Construction
- Crevice-free design to avoid stagnation and bacterial growth
- All pure steam contact parts are electro-polished
- All pipe joints are orbitally welded
- Double tube sheet construction to prevent mixing of plant steam and pure steam in case of tube sheet weld failure
- Gaskets made from pure PTFE (Teflon) or pharmaceutical-grade silicone
The equipment is designed as per ASME standards and is CE approved for PED regulations as per European Union requirements.
Outstanding Features
- Construction in SS 316L (DIN 1.4435) with electro-polished active surfaces
- Double tube sheet design for heat exchangers and all pre-heaters
- Glass wool insulation with AISI 304 stainless steel cladding
- All WFI contact parts electro-polished using state-of-the-art technology
- ASME BPE stamped pipes and tubes with surface finish Ra ≤ 0.5 µm
- Frame constructed from AISI 304 stainless steel
- Electro-polished piping with orbital welding, sanitary fittings, and pharma-grade gaskets
- Expansion joint design for tube-to-tube sheet connections
- PLC-based operation with validated logic and required safety interlocks
- Skid-mounted AISI 304 stainless steel control panel
- Complete documentation compliant with international audit requirements
Optional Features
- Fully automatic operation for boiler steam supply, feed water flow, and cooling water flow
- PLC system with SCADA, validated as per 21 CFR Part 11
- CE and UL certification
- Double tube sheet design for all pre-heaters and both top coolers
General Ask
You can reach us via the Contact Us page on our website. Fill out the inquiry form or get in touch directly through phone or email for product inquiries, quotations, or technical support.
Pharma Engineers is committed to delivering top-tier engineering solutions that meet industry standards and client expectations. From concept to commissioning, we bring excellence, compliance, and innovation to every project.
