Water for Injection Equipment

Water for Injection (WFI) equipment is specialized machinery used to produce water that meets the requirements for pharmaceutical preparations.

I. Main Equipment Types

- Multi-effect Distillation Unit: This is one of the core pieces of equipment. As mentioned earlier, it utilizes the principle of multi-effect evaporation, making multiple uses of steam to produce high-purity distilled water. Taking a triple-effect distillation unit as an example, the first-effect evaporator uses external steam to heat the feed water and generate steam, which then serves as the heat source for the second-effect evaporator. The steam produced by the second-effect is used in the third-effect, ultimately yielding high-purity distilled water that effectively removes impurities, microorganisms, and endotoxins from the water.
- Pure Steam Generator: Used to produce pure steam for sterilizing and disinfecting WFI equipment and pipeline systems. It uses deionized water or distilled water as the feed, heating the water to produce steam. During steam generation, it removes any residual impurities in the water, ensuring the purity of the steam.
- Reverse Osmosis (RO) System: Plays a critical role in the pretreatment stage. Using the principle of semi-permeable membranes, it forces water through the membrane under pressure while retaining impurities. This process removes most salts, organic matter, microorganisms, and other contaminants, providing better-quality feed water for subsequent deep treatment.

II. System Components

- Pretreatment System:
- Includes a raw water tank for storing raw water; a raw water pump to provide the power for water delivery; as well as sand filters and activated carbon filters. Sand filters remove larger particulate impurities such as suspended solids and sediment from the water, while activated carbon filters adsorb organic matter, residual chlorine, etc., improving the odor and taste of the raw water and providing a better water quality foundation for subsequent treatments like reverse osmosis.
- Reverse Osmosis System:
- Primarily consists of RO membrane modules, which are the core components. Composed of multiple layers of RO membranes, they remove ions, small organic molecules, and other impurities with high precision. Also included is a high-pressure pump, which provides sufficient pressure for the reverse osmosis process to allow water to pass through the RO membrane effectively.
- Ion Exchange System (Optional):
- Used in some cases when further improvement in water quality is needed after reverse osmosis. It employs ion exchange resins to remove remaining ions from the water, further reducing its conductivity and achieving higher purity.
- Terminal Treatment System:
- Includes equipment such as ultraviolet (UV) sterilizers, which use UV radiation to destroy the DNA structure of microorganisms, killing residual bacteria and viruses in the water. Also, 0.22μm precision filters are used to trap tiny particles and microorganisms, ensuring that the particulate matter in the water for injection meets standards.

III. Quality Control

- Water Quality Monitoring: The equipment is equipped with various water quality monitoring instruments, such as conductivity meters and Total Organic Carbon (TOC) analyzers. Conductivity meters monitor the ion content in the water in real-time, as water for injection requires very low conductivity. TOC analyzers are used to detect the total amount of organic carbon in the water, ensuring that the organic content meets standards, such as the Chinese Pharmacopoeia requirement that TOC in water for injection should not exceed 0.5 mg/L.
- Equipment Cleaning and Sterilization: To prevent microbial growth and contamination, the equipment requires regular cleaning and sterilization. Pure steam sterilization is a commonly used method to sterilize pipelines, containers, and other parts of the equipment, eliminating any potential microorganisms. Additionally, specialized cleaning procedures are in place for components like RO membranes. Depending on the level of membrane fouling, appropriate cleaning agents are used, such as acidic cleaners to remove metal oxides and alkaline cleaners to remove organic matter.