Water for injection generation and storage system

Water for injection generation and storage system

 

Micmedicalmachine LDS series Multi effect water distiller is a kind of water for injection generation equipment using purified water as raw water, and heated by industrial steam.

 

The water for injection produced by LDS series Multi effect water distiller meets the requirements of WFI in Chinese Pharmacopoeia (Cp2020), United States Pharmacopoeia (USP43) and European Pharmacopoeia (EP10).

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Principle Qualified raw water is pressurized by a multi-stage pump and then enters the condenser, and then enters each effect preheater in turn (the raw water is heated by secondary steam and distilled water in the condenser, and after entering each effect preheater is heated by condensed water of secondary steam, which will be heated by industrial steam condensed water in the first-effect preheater). Then it enters the first-effect evaporator and sprayed on the inner wall of the heating tube through the material water distributor, so that the material water flows in a film status on the tube wall, and is heated and vaporized by the industrial steam. The generated secondary steam with water droplets enters the raw-water separator from the lower end of the evaporation chamber. The separated pure steam enters the next effect as heating steam, and the unevaporated steam-water enters the next effect, and the above process is repeated. The pure steam generated by the final effect enters the condenser and is cooled by condensing water from each effect except the first effect. After removing the non-condensable gas (depending on the model, the evaporator may also be equipped with such a continuous discharge device of non-condensable gas). Condensed gas becomes water for injection. The outlet generally undergoes online conductivity testing, qualified distilled water is output as water for injection, and unqualified distilled water will be discharged.

1. Water for injection generation and storage system ensures safe, compliant water production and supply.
2. Its structure features double-tube-sheet design for the external preheater, condenser, and first-effect evaporator (inner sheet expanded and welded externally to prevent cross-contamination).
3. A three-stage separation device (falling film evaporation + gravity + spiral flow) refines the process.
4. All raw water, product water, and secondary-steam contact parts use SS316L.
5. The evaporator, preheater, and condenser rely on aluminum silicate needle-punched blankets for thermal insulation (good extensibility, light weight, etc.).
6. Electrochemical polishing smooths internal and external surfaces.
7. Energy-saving multi-effect distillation reuses secondary steam step-by-step, cutting industrial steam use and cooling water (five-effect needs little, six-effect none).
8. Piping uses stainless-steel elbows (minimizing welding); welded parts get argon-protected automatic welding (single-side welding, double-side forming) plus post-weld electrochemical polishing.
9. Verification materials (endoscopy photos, etc.) prove quality.
10. The HMI+PLC control system enables full automation, simple operation, multi-communication modes, and at least three authority levels.
11. Online monitoring tracks conductivity, temperature, and flow (paperless/paper recorders optional).
12. Optional electronic signatures/records create audit trails, meeting GAMP 5 and 21 CFR PART 11.
13. Ideal for wholesale water for injection generation and storage system business, it guarantees reliable water for injection generation and storage system supply.

System advantage

1. Strong Compliance: It adopts SS316L contact material, double tube plate structure, and argon arc welding process. The produced water meets the standards of Chinese Pharmacopoeia (CP2020), United States Pharmacopoeia (USP43), and European Pharmacopoeia (EP10), satisfying GAMP 5 and 21 CFR PART 11 compliance requirements, thus adapting to the strict regulatory needs of the pharmaceutical industry.
2. High Water Purity: Through three-stage separation technology of falling film evaporation + gravity + cyclone, combined with electrochemical polishing surface treatment, it avoids cross-contamination and microbial growth, ensuring the high purity of injection water.
3. Energy-Saving and Efficient: Multi-effect distillation recovers secondary steam step by step. The more evaporators there are, the more significant the energy-saving effect (six-effect distillation does not require cooling water), greatly reducing industrial steam and cooling water consumption, and lowering operating costs.
4. High Automation and Safety: HMI + PLC full automation control supports three-level permission management, online monitoring of conductivity / temperature / flow, and electronic signature audit trail, making operation convenient and data traceable.
5. Stable and Durable: The aluminum silicate needle-punched blanket insulation layer has both heat insulation and stability. The pipeline adopts a design with fewer welds + argon arc protected welding, extending the equipment service life and adapting to long-term continuous operation scenarios.

Applications

1. Pharmaceutical Industry: Used for mixing, dissolving, cleaning, and sterilization in the production processes of injectables, biologics, vaccines, etc. It is a core equipment for GMP-compliant production in pharmaceutical enterprises and a major application scenario for the generation and storage system of water for injection.
2. Healthcare Industry: Suitable for medical instrument sterilization water in hospital operating rooms and disinfection supply centers, as well as scenarios such as clinical intravenous infusion and drug dilution, ensuring medical water safety and supporting the healthcare-end demand for the water for injection generation and storage system supply.
3. Biotechnology Field: Meets the strict requirements for sterile high-purity water in bioreactor cultivation and cell product manufacturing, providing stable water quality assurance for biotechnology enterprises.
4. High-End Laboratories: Serves precise experiments such as drug R&D and clinical testing, providing standard-compliant laboratory water to ensure the accuracy of experimental results.
5. Chemical and Electronic Industries: Used in scenarios such as high-purity chemical raw material synthesis and electronic component cleaning, adapting to industrial production links with high requirements for water purity.