Pharmaceutical Water for Injection Equipment

Pharmaceutical water for injection equipment is a critical device used in the drug manufacturing process to produce high-purity, sterile water for injection. It mainly consists of the following parts:

1. Pretreatment Equipment:
- Raw Water Tank: Used to store raw water before initial treatment, typically made of food-grade stainless steel to prevent contamination. Its capacity depends on production requirements.
- Raw Water Pump: Provides the driving force for transporting raw water from the raw water tank to subsequent treatment equipment. It requires stable performance and appropriate flow and pressure.
- Multi-Media Filter: Usually filled with filtration media such as quartz sand and anthracite coal, it removes larger particulate impurities like suspended solids, sediment, and colloids from raw water, providing preliminary purification.
- Activated Carbon Filter: Utilizes the adsorption capacity of activated carbon to remove organic matter, residual chlorine, odors, and some heavy metals from raw water, improving its chemical stability and sensory properties.
- Softener (Optional): If the raw water has high hardness, the softener uses ion exchange resin to remove hardness ions such as calcium and magnesium, preventing scale formation in subsequent processes that could affect equipment operation and water quality.
2. Reverse Osmosis Equipment (Optional but Commonly Used):
- High-Pressure Pump: Provides sufficient pressure for the reverse osmosis process, forcing water through the reverse osmosis membrane. The pressure typically ranges from 1-10 MPa, depending on the membrane model and requirements.
- Reverse Osmosis Membrane Module: The core component of the reverse osmosis system, consisting of multiple layers of reverse osmosis membranes. It removes the vast majority of salts, organic matter, microorganisms, and other impurities from water, significantly reducing the conductivity of the produced water, with a desalination rate of 98%-99% or higher.
3. Distillation Equipment:
- Multi-Effect Distillation Unit: A key device for producing water for injection. It generally includes triple-effect, quadruple-effect, or more evaporators. Taking a triple-effect distillation unit as an example, the first-effect evaporator uses external steam to heat the feed water to generate steam, which then serves as the heat source for the second-effect evaporator. The steam from the second effect acts as the heat source for the third-effect evaporator. Through multiple evaporation-condensation cycles, impurities, microorganisms, and endotoxins are effectively removed, resulting in high-purity water for injection.
- Condenser: Primarily used to condense the steam generated by the last-effect evaporator into liquid water. Condensers come in various structural forms, such as shell-and-tube or plate types, and use a cooling medium (e.g., cooling water) to remove heat from the steam, causing it to liquefy.
4. Storage and Distribution Equipment:
- Water for Injection Storage Tank: Made of 316L stainless steel with an electropolished and passivated inner surface to minimize metal ion leaching. The tank should have excellent sealing to prevent external contamination, along with insulation or heating devices to maintain the water temperature within a suitable range and avoid microbial growth. It is also equipped with a breather, typically a 0.2μm hydrophobic filter, to balance internal and external pressure while preventing airborne microorganisms and impurities from entering.
- Transfer Pump: Usually made of 316L stainless steel, it is used to deliver water for injection from the storage tank to various points of use, such as formulation tanks and bottle washers in the production area. The pump should provide stable flow and appropriate pressure while ensuring leak-free and contamination-free operation.
- Piping System: Pipes are primarily made of 316L stainless steel with electropolished inner surfaces. Welding processes must be stringent to ensure smooth and even internal surfaces. Valves are generally diaphragm valves, known for their excellent sealing, ease of cleaning and sterilization, and effectiveness in preventing microbial growth and impurity ingress.
5. Auxiliary Equipment:
- Water Quality Monitoring Instruments: Include conductivity meters, total organic carbon (TOC) analyzers, bacterial endotoxin testing instruments, pH meters, etc., to monitor water quality in real time and ensure the produced water for injection meets relevant pharmaceutical standards.
- Disinfection Devices: Such as ultraviolet sterilizers and ozone generators, used for periodic disinfection of pretreatment equipment, storage tanks, and pipelines to maintain the system's sterile condition.