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Electric-Heated Pure Steam / WFI Integrated Unit

Welkin’s DPSG-E electric single-effect distiller is a multifunctional device that integrates the functions of a pure steam generator and a distilled water system. Specifically designed for the R&D and pilot-scale phases of growing pharmaceutical companies, it effectively addresses the core challenge faced by customers who, despite limited plant space, tight budget constraints, and insufficient operational and maintenance capabilities, still demand exceptionally high-quality produced water (and steam).

Application Conditions
· This system can alternately produce pure steam or water for injection, with seamless switching between the two operating modes.
· Saturated pure steam without a heat source can be used for sterilization in sterilization cabinets, bioreactors, formulation tanks, and piping systems—process sections that come into direct or indirect contact with the final product.
· It can also be used for humidity control in high-cleanliness-class areas; Water for Injection may be used for the dissolution and formulation of sterile products, as well as for the cleaning of systems that come into direct or indirect contact with sterile products.

Advantages
· The electric-heated single-effect pure steam distillation water-in-one unit (DPSG-E series) is designed, constructed, and validated in accordance with the latest FDA and GMP requirements. It can provide customers with Water for Injection and pure steam that meet the standards of the Chinese, U.S., and European Pharmacopoeias; moreover, the quality of the pure steam also complies with the SIP sterilization requirements specified in HTM2010 (EN 285). Factory Acceptance Testing (FAT), combined with DQ, IQ, and OQ, ensures both performance and product quality for customers.
· SS316L and Incloy 800 stainless steel shall be used for contact with the product’s metal components, with a surface finish requirement of Ra < 0.6 µm;
· Non-metallic components in contact with the product shall be made from materials compliant with FDA or USP Class VI standards;
· Strictly control key quality monitoring points, such as system dead zones, slope, and drainage capacity;
· The injection water makeup system enables fully automated steam purging and sterilization, with no baffles or other dead zones on the product water side that could impede cleaning and sterilization.
· Continuous monitoring of product water (steam) conductivity, temperature, and pressure, with data recorded by a recorder.

Easy to install and maintain
· All electric heaters are easy to disassemble and maintain;
· Modular design with a high degree of integration: on-site commissioning requires only connections for purified water, tap water, compressed air, and power; steam and chilled water are not required.
· Pressure-type condenser: the equipment has a relatively low overall height, requiring less installation space in the plant building.

Control System
· Control systems compliant with GAMP5 and 21 CFR Part 11 provide operators with a secure, user-friendly interface, enabling fully automated operation with real-time monitoring and data recording.

Product Specifications and Parameters

Model	DPSG50—E	DPSG75—E	DPSG100—E	DPSG150—E
Pure Steam Capacity	50 kg/h at 3 bar	75 kg/h at 3 bar	100 kg/h at 3 bar	150 kg/h at 3 bar
Injection water production capacity	50 L/h at 90°C	75 L/h at 90°C	100 L/h at 90°C	150 L/h at 90°C
Power supply	55 kW, 380 VAC	80 kW, 380 VAC	110 kW, 380 VAC	160 kW, 380 VAC
Purified Water Requirements	55 L/h @ 0.5” TC	83 L/h @ 0.5” TC	110 L/h @ 0.5” TC	165 L/h @ 0.5” TC
Softened water (tap water)	Max.1000L/h	Max.1500L/h	Max.2000L/h	Max.3000L/h
Compressed air	6barg@0.5"TC	6barg@0.5"TC	6barg@0.5”TC	6barg@0.5”TC
Total Height/H mm	2400	2400	2400	2600
Total length/Lmm	1950	1950	2050	2200
Overall width/W mm	900	1000	1000	1000
Net weight/kg	375	400	450	550
Electrical conductivity / µS/cm Microorganisms/CFU/100 ml Endotoxin/EU/ml	<1.0 µS/cm at 25°C <10 <0.25

Simple design, stable operation
· The evaporator features a fully immersed design utilizing high-quality electric heaters, eliminating stress concentration and dry-heating, and reducing scaling.
· The separator contains no components that require maintenance, cleaning, or are prone to contamination;
· The internal hydrothermal convection circulation in the evaporator and separator facilitates the removal of endotoxins;
· The condenser features a double-tube-sheet design, with pure steam flowing on the tube side, resulting in high heat-transfer efficiency and no stress concentration.
· Thermal degassing of purified water removes insoluble gases, ensuring the quality of pure steam while enhancing system operational stability;
· The feed water for purified water, the product water for injectable water, the cooling of injectable water, as well as the preheating and steam-generation electric heaters are all subject to continuous PID control via a PLC, ensuring high system operational stability.

Keywords:

Welkin

Clean Steam Generator

Purified Water Distribution Module

Electric-Heated Pure Steam / WFI Integrated Unit

Welkin’s DPSG-E electric single-effect distiller is a multifunctional device that integrates the functions of a pure steam generator and a distilled water system. Specifically designed for the R&D and pilot-scale phases of growing pharmaceutical companies, it effectively addresses the core challenge faced by customers who, despite limited plant space, tight budget constraints, and insufficient O&M capabilities, still demand exceptionally high-quality produced water (and steam).

sales@welkin-cn.com

0510-85258905

Product Category:

Pharmaceutical Water System

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