Water for Injection Equipment for Biologics

Water for Injection Equipment for Biologics

1. Equipment Composition
- Pretreatment Unit
- Raw Water Tank: Stores raw water, typically made of food-grade stainless steel to prevent microbial growth and contamination. Its capacity depends on the production scale.
- Raw Water Pump: Provides the necessary pressure to ensure a stable flow of water to subsequent treatment equipment. It generates appropriate pressure and flow to maintain system operation.
- Multi-Media Filter: Contains various filtration media such as quartz sand and activated carbon. Quartz sand removes larger suspended particles, silt, and sediment; activated carbon adsorbs organic matter, residual chlorine, and some heavy metals, and also eliminates odors.
- Softener (Optional): If the raw water has high hardness, the softener uses ion exchange resin to remove calcium, magnesium, and other ions, preventing scale formation in downstream equipment.
- Reverse Osmosis Unit (Often part of the pretreatment)
- High-Pressure Pump: Provides sufficient pressure (typically 1 - 10 MPa) to force water through the reverse osmosis membrane. The required pressure depends on the membrane type and specific process requirements.
- Reverse Osmembrane Module: The core component, utilizing a semi-permeable membrane to retain most salts, organic matter, microorganisms, and other impurities. The desalination rate can reach 98% - 99% or higher, significantly improving water purity.
- Distillation Unit
- Multi-Effect Distillation Water Still: A key device for producing water for injection in biologics. For example, a triple-effect distillation still uses external steam to heat the feed water in the first effect, generating steam that serves as the heat source for the second effect. The steam from the second effect then heats the third effect. Through multiple evaporation-condensation cycles, impurities, microorganisms, and endotoxins are effectively removed, ensuring high water purity.
- Condenser: Condenses the steam from the final effect into liquid water. It comes in various structures, such as shell-and-tube or plate-type, and uses a cooling medium (e.g., cooling water) to remove heat from the steam for liquefaction.
- Storage and Distribution Unit
- Water for Injection Storage Tank: Made of 316L stainless steel with an electropolished and passivated inner surface to minimize metal ion leaching. The tank is well-sealed and equipped with insulation or heating to maintain stable water temperature and prevent microbial growth. It also includes a 0.2 μm hydrophobic vent filter to balance internal and external pressure while preventing airborne contaminants.
- Transfer Pump: Typically made of 316L stainless steel, it delivers water for injection to various points of use in biologics production. The pump ensures stable flow, appropriate pressure, and is leak-free and contamination-free.
- Piping System: Primarily constructed from 316L stainless steel with electropolished interiors, using welded or sanitary fittings. Diaphragm valves are commonly used for their excellent sealing, ease of cleaning and sterilization, and effectiveness in preventing microbial growth and contamination.
2. Quality Control and Monitoring Equipment
- Water Quality Monitoring Instruments: Equipped with a conductivity meter to monitor ion content (water for injection in biologics typically requires low conductivity); a Total Organic Carbon (TOC) analyzer to detect the total organic carbon in water; a bacterial endotoxin tester to ensure endotoxin levels meet strict standards (generally less than 0.25 EU/mL); and a pH meter, among others, for real-time water quality monitoring.
- Disinfection Devices: Include ultraviolet (UV) sterilizers and pure steam generators. UV sterilizers use ultraviolet light to destroy microbial DNA for sterilization; pure steam generators produce pure steam for sterilizing equipment and piping systems, maintaining an aseptic state.
3. Equipment Maintenance Key Points
- Regular Cleaning and Disinfection: Perform periodic cleaning of filters in the pretreatment unit, distillation unit, storage and distribution unit, etc., to remove dirt and biofilms. Use methods such as pure steam sterilization and chemical disinfectants to ensure equipment sterility.
- Component Inspection and Replacement: Regularly inspect components like reverse osmosis membranes, ion exchange resins, filter cartridges, and valve seals. Replace them based on service life and operational conditions to ensure proper equipment function and consistent water quality.