Water for GMP Preparations
Pharmaceutical water generally includes several types: drinking water, purified water, water for injection, and sterile water for injection;
Drinking water, also known as raw water, is usually tap water. According to the 2020 Chinese Pharmacopoeia, drinking water cannot be directly used as water for the preparation of formulations or experimental use;
Purified water is water obtained through a special process and does not contain any additives. Purified water can be used as a solvent for the preparation of ordinary drug formulations or experimental water, but it is not allowed for the preparation of injectables.
Water for injection is obtained from purified water as the raw water, through a distillation device, and can be used as a solvent for the preparation of injectables.
Process Flow Example
Purified Water and Water for Injection Preparation Process Flow Description
(1) Raw Water Pre-treatment Stage
After raw water enters the system, it is first temporarily stored in the raw water tank, then passes through a sand filter (to remove suspended solids) and an activated carbon tank (to adsorb organic matter/ residual chlorine), while anti-scaling agents are added to inhibit the crystallization and precipitation of inorganic salts, preventing scaling and blockage on the RO membrane surface. It then enters the security filter (precision filtration) to further intercept tiny particles and protect the subsequent reverse osmosis membrane.
(2) Reverse Osmosis Desalination Stage
The primary high-pressure pump pressurizes the pre-treated water and sends it into the primary reverse osmosis device to remove most ions and organic substances. The concentrated water from the primary stage enters the secondary high-pressure pump and secondary reverse osmosis for further desalination, ensuring the water quality meets the purified water standard.
(3) EDI (Electrodeionization) Refining Stage
The secondary RO product water is stored in the EDI water tank, then enters the EDI module through the EDI booster pump, using an electric field and ion exchange resin to continuously remove residual ions, producing high-purity water.
(4) Water for Injection Preparation Stage
Part of the purified water enters the multi-effect distillation water machine, and after high-temperature distillation, it is stored in the distillation water tank, ultimately producing water for injection that meets pharmacopoeia standards.
Core Advantages
(1) Full industry chain autonomy ensures high system reliability
Multi-effect distillation water machine independently developed and produced: The company has the independent production capacity for multi-effect distillation water machines (MED), with core components (such as evaporators, condensers, control systems) designed and manufactured independently, ensuring that the high-temperature water for injection (WFI) system complies with international standards such as the Chinese Pharmacopoeia (ChP), USP, EP.
Purified water equipment modular assembly: Customizable assembly of purified water systems with RO (reverse osmosis) + EDI (electrodeionization) or mixed bed processes to meet the water quality requirements of different industries (pharmaceuticals, biologics, medical devices), shortening delivery cycles and reducing maintenance costs.
(2) Compliance design in line with international certification
Strictly follows GMP/ISPE/FDA/EMA guidelines:
Material: 316L stainless steel electropolished piping, Ra ≤ 0.6μm, meeting ASME BPE standards.
Intelligent control system: Integrated SCADA + PLC to achieve remote monitoring, data traceability, alarm management, and compliance with data integrity requirements.
(3) Energy-efficient technology to reduce customer operating costs
Heat recovery technology: Multi-effect distillation water machines use multi-stage waste heat utilization, saving more than 50% energy compared to traditional single-effect distillation.
Green process design: EDI technology replaces traditional mixed beds, reducing acid and alkali consumption and wastewater discharge.
(4) Full life cycle service to ensure long-term stable system operation
One-stop service from design to operation and maintenance:
Provides full-process support for water quality analysis, process design, equipment manufacturing, installation and commissioning.
