1000LPH Multi-effect Distilled Water System for Water for Injection in China
A medium-sized pharmaceutical enterprise in China focuses on the production of sterile injections and lyophilized preparations. To meet the requirements of the new GMP regulations and solve problems such as the capacity, pyrogen control, and monitoring data traceability of water for injection (WFI) production equipment, it urgently needs a water for injection preparation system that adapts to the production line and meets compliance standards. The customer found the contact information of Molewater’s employees, and after research and technical demonstration by engineers from both parties, it was finally decided to design this multi-effect distilled water system. The core goals are to achieve stable production of water for injection, full-process compliance and controllability, and reserve space for subsequent capacity expansion
Project challenges
Strict compliance requirements: It must strictly comply with the requirements of the “Chinese Pharmacopoeia (2020 Edition)” and “Good Manufacturing Practice for Drugs (GMP)”. The produced water must meet key indicators such as conductivity ≤0.06μS/cm (25℃), total organic carbon ≤50ppb, microorganisms ≤10CFU/100mL, and endotoxin ≤0.25EU/mL. Moreover, it is necessary to realize real-time water quality monitoring and full-process data traceability.
Capacity adaptation requirements: The peak water consumption of water for injection in the production line is about 950LPH. The system needs to stably output 1000LPH of qualified produced water, and at the same time adapt to the enterprise’s original purified water pretreatment system, storage tanks, and pipeline layout to avoid large-scale transformation and control the project cycle and cost.
Energy consumption and operation and maintenance adaptation: The system needs to balance high efficiency, energy saving, and ease of operation and maintenance, adapt to the technical capabilities of the internal operation and maintenance team, reduce manual intervention, and lower long-term operation and maintenance costs.
Sterilization and anti-pollution guarantee: It is necessary to be equipped with a complete pure steam sterilization system to realize online sterilization (SIP) of the distilled water machine, storage tank, and distribution pipeline, eliminate secondary pollution, and ensure the sterile state of water for injection from preparation to use.
Process flow
Connection of pre-pretreatment: Using the qualified purified water produced by the enterprise’s original purified water system (double-stage reverse osmosis + EDI) as the inlet water of the distilled water machine, adding a pre-precision filter and an inlet water quality monitoring module to ensure stable inlet water quality and extend the service life of the distilled water machine.
Core preparation unit: Adopting a multi-effect distilled water machine with a 6-effect evaporation structure, using industrial steam as the heat source. Through multi-stage heat recovery and utilization, the thermal efficiency is increased to over 85%, and the energy consumption is reduced by 30% compared with the traditional single-effect distilled water machine; the equipment is made of 316L stainless steel, equipped with automatic water replenishment, liquid level control, over-temperature alarm, fault shutdown, and other protection functions to ensure stable operation.
Sterilization and distribution system: Equipped with a pure steam generator (adapting to the sterilization needs of the distilled water system) to realize online sterilization (SIP, 121℃, 30 minutes) of the distilled water machine, water for injection storage tank, and distribution pipeline; the distribution pipeline adopts a closed-loop design to maintain the water flow rate in the pipeline ≥1m/s, avoiding the growth of microorganisms in stagnant water, and at the same time setting terminal precision filtration (0.2μm) and online monitoring points (conductivity, TOC, temperature, pressure)
Project achievements
Zero risk of compliance and qualification: The produced water quality is continuously stable. Key indicators such as conductivity, TOC, microorganisms, and endotoxins all meet the requirements of the “Chinese Pharmacopoeia” and GMP. The qualified rate of third-party testing is 100%. The data traceability system has passed the inspection of the drug regulatory authority, helping the enterprise successfully pass the GMP re-certification.
Optimization of energy consumption and costs: The multi-effect distillation process significantly reduces energy consumption. The system has a high degree of automation and only requires one manual inspection per day. The operation and maintenance personnel can operate independently after simple training, and the annual operation and maintenance cost is reduced by 40%.
Efficient and stable capacity adaptation: The water production capacity can fully cover the peak water demand of the production line. The system operates continuously without water supply interruption, effectively ensuring production continuity.
Guaranteed pollution prevention and control: The online sterilization system and closed-loop pipeline design completely eliminate secondary pollution. After commissioning, the risk of microbial contamination in the injection production line is reduced to zero, and the product quality stability is significantly improved, laying a solid foundation for the enterprise’s subsequent product market expansion