Pharmaceutical Water Treatment Solution

A full-process water safety barrier for pharmaceuticals: Molewater uses technology to lay a pure foundation for drug production.

In Pharmaceutical, water treatment faces strict and complex requirements, complying with GMP, ChP, USP, and other pharmacopoeial standards with tight controls on microorganisms, endotoxins, TOC, and conductivity. Water quality varies across API, sterile preparations, and biopharmaceutical production, demanding flexible, multi‑adaptable systems.Frequent regulatory audits also require full data traceability and automated compliance, while manual recording raises significant compliance risks.

Stable, reliable operation is essential, as any water quality deviation can cause batch losses and production downtime. Systems must feature redundancy and emergency switching capabilities. Traditional systems suffer low water recovery, high energy use and heavy maintenance costs. Meanwhile, biofilms in pipelines remain hard to control, and weak disinfection creates microbial and endotoxin risks that directly threaten drug safety and continuous production.

Every drop of water filtered is crucial to drug safety; through double-stage reverse osmosis + EDI process and online TOC monitoring, Molewater ensures the produced water strictly meets pharmaceutical standards.

Ensuring Compliance and Excellence in Pharmaceutical Water Systems

Molewater advanced water purification solutions are designed to meet strict pharmaceutical requirements, combining sustainable technology and intelligent management to ensure safe drug production and high operational efficiency.

  • Water Quality Compliance and Safety Stability: Our systems produce purified water meeting pharmacopoeial standards to ensure drug production safety and consistent quality.
  • Low Energy & Maintenance Costs: Facilities focus on high water recovery, low energy use, and smart monitoring to reduce operating expenses. Remote O&M and auto-alarm functions help minimize manual intervention.
  • Intelligent monitoring and smart management: A PLC+HMI platform enables real-time multi-parameter monitoring, remote fault warning, and streamlined O&M, improving efficiency and risk control.
  • Compliance and data traceability: Automated data logging, audit trails, and MES integration support electronic signatures and tamper-proof data for regulatory compliance and audits.
  • Full-process validation and service support: End-to-end services including DQ/IQ/OQ/PQ validation documentation and compliance training ensure long-term stable, regulatory-compliant operation.

Relevant Technologies

The system adopts a combined filtration process of multi-media filtration + activated carbon adsorption + softening + precision filtration, effectively protecting the service life of downstream RO membranes and EDI modules.

As the core purification process of the system, it optimizes pressure distribution through multi-stage membrane modules, effectively removing over 99% of dissolved salts, heavy metals, microorganisms, and endotoxins from water.

Combining electrodialysis and ion exchange, this technology achieves resin regeneration under a DC electric field without acid-base regeneration, avoiding residual chemical substances and ensuring the produced water resistivity is stably maintained at 16 – 18.2 MΩ·cm. It is a core green process for preparing “purified water”.

Equipped with 254nm UV sterilization and 0.22μm terminal sterile filtration, the microorganism removal rate is ≥99.99%, and endotoxin ≤0.25EU/ml to meet GMP sterility requirements.

Adopting Siemens’ control system and logic editor, it can realize real-time online monitoring of conductivity, TOC, flow rate, pressure, etc., with functions such as one-key start-stop, automatic water production, and system automatic alarm, avoiding failures of expensive biochemical analyzers caused by water quality fluctuations.
 

Achievements We Deliver for Pharmaceutical Water Treatment

Water quality compliance guarantee: The produced water stably meets ChP/USP/EP pharmacopoeial and GMP standards, with endotoxin ≤0.25EU/ml, eliminating drug quality risks from the source.

Stable system operation: Double-stage RO + EDI process enables continuous and stable water production, with a system recovery rate of 75%–85%, significantly reducing downtime and ensuring efficient operation of the production line.

Cost reduction and efficiency improvement: EDI requires no acid-base regeneration, reducing operation and maintenance costs by 50%; intelligent automatic operation saves labor and energy consumption, resulting in lower life-cycle costs.

Convenient compliance: Online monitoring + 10-year data traceability facilitates smooth passage of GMP/FDA audits, meeting high-demand scenarios such as sterile preparations and biopharmaceuticals.

Pharmaceutical Water Treatment Solutions

Pharmaceutical Water Systems
  • API production water solution
  • Injection/oral preparation raw material production water solution
  • Biopharmaceutical/vaccine production water solution
  • Traditional Chinese medicine product production water solution
  • Multi-effect distilled water for injection solution
  • Pure steam solution for water for injection

Applications

Our pharmaceutical water treatment solutions serve key industry scenarios with reliable, compliant performance.

Oral preparation and injection raw material production

In oral preparation and injection production factories, the pharmaceutical purified water system is the core guarantee for drug production. The high-purity water it provides serves as a key raw material, which can completely remove ions, organic substances, and microorganisms, directly ensuring drug safety and effectiveness. Stable water quality can ensure uniform mixing of drug ingredients, avoid production process fluctuations, and is also a mandatory prerequisite for enterprises to meet regulatory requirements such as GMP and obtain production qualification certification.

API production

In the API synthesis scenario, the pharmaceutical purified water system is the core guarantee for supporting product purity and production efficiency: In chemical API synthesis, it serves as a solvent or quenching agent to reduce side reactions and improve product yield, and can effectively remove impurities in the purification link to ensure API purity meets pharmacopoeial standards; In biological API preparation, it is used to prepare culture media and buffers, avoiding contamination by miscellaneous bacteria and endotoxins to ensure normal cell growth, and serves as a chromatography medium equilibration solution, which is a key support for maintaining downstream separation and purification effects and ensuring the activity and purity of biopharmaceuticals.

Traditional Chinese medicine product production

In the traditional Chinese medicine preparation production scenario, the pharmaceutical purified water system is an important support for promoting the standardization of traditional Chinese medicine quality: In the extraction and purification links, it serves as an extraction solvent to maximize the retention of active ingredients in medicinal materials, avoid impurity interference, and reduce impurity residues by adjusting the concentration of medicinal liquid, ensuring the purity and batch stability of extracts; In the preparation forming stage, it is used for granulation and formulation, and the stable water quality reduces differences between preparation batches, helping traditional Chinese medicine products achieve quality standardization, which is a key guarantee for the modernization and internationalization of traditional Chinese medicine.

Multi-effect distilled water system for injection

The multi-effect distilled water system is the core process equipment for producing water for injection (WFI) in the pharmaceutical industry. Through multi-stage evaporation and condensation, it can completely remove ions, organic substances, microorganisms, and pyrogens from water, stably meeting the requirements of USP, EP, BP, and pharmacopoeias of various countries for key indicators such as endotoxins (≤0.25 EU/mL). It is the only compliant water source for the production of sterile injections, vaccines, and other drugs; It is not only an essential facility for enterprises to pass GMP certification and meet drug regulatory requirements, but also achieves high efficiency and energy saving through multi-stage heat recovery, reducing long-term operating costs. Meanwhile, the closed structure and automatic control ensure stable water production and avoid secondary pollution, safeguarding drug quality and patient medication safety from the source, and playing an irreplaceable key role in pharmaceutical production.

Pure steam system

The pure steam system is a key supporting facility for ensuring sterile production in the pharmaceutical water treatment system. It produces clean steam without pyrogens and condensates through a pure steam generator, which can perform online sterilization (SIP) on purified water/WFI pipelines, storage tanks, filters, and production equipment, effectively killing microorganisms and destroying endotoxins, meeting the sterilization requirements of GMP and pharmacopoeias of various countries for sterile preparation production; Its stable and clean steam supply can avoid secondary pollution caused by traditional industrial steam, ensuring the sterile state of the entire water treatment and production system, and is an indispensable core link for ensuring drug safety and realizing compliant production.

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