Water For Injection (WFI) Solution

LDS Multi-Effect Distiller is a core equipment in the pharmaceutical industry for producing Water for Injection (WFI) that complies with the highest pharmacopoeia standards (such as ChP, USP, EP, JP, etc.). Based on the principle of thermal distillation, it efficiently utilizes thermal energy by connecting multiple evaporation “effects” in series. Purified water is heated to boiling to generate steam, which is then condensed to obtain high-purity WFI. This process effectively removes all non-volatile substances (ions, particles, colloids, organic matter) as well as microorganisms and their metabolic products (endotoxins) from the water.

Characteristics of Water for Injection

It exhibits extremely low conductivity, Total Organic Carbon (TOC), and endotoxin levels, fully meeting the stringent requirements for WFI as specified in various pharmacopoeias.

Technology of Multi-effect Water Distilling Treatment

Modular components of Water Distilling Treatment

1. Feedwater Pump System

Feedwater pump optional insalled enhances the feedwater pressure

2. System Components

Preheaters
Evaporators
Condensors
Steam Seperators
Controls

3. Post-Treatment and Distribution

WFI Storage Tank
WFI level transmitter
WFI pump
Sanitary heat exchanger
Conductivity analyzer
TOC analyzer
Flow & pressure instriuments
SIP equipment

The primary applications of Water for Injection (WFI) are concentrated in pharmaceutical production where the strictest control of sterility and pyrogens is required:

As a solvent for preparing injectable formulations: This is the most critical use of WFI. Many drugs administered via injection (such as intravenous, intramuscular, or subcutaneous routes) are in powder or concentrated liquid form and must be dissolved or diluted with WFI immediately before clinical use. Since these products enter directly into human blood or tissues, the solvent itself must be sterile and pyrogen-free.

Final rinse of primary packaging components: This is the most critical use of WFI. Many drugs administered via injection (such as intravenous, intramuscular, or subcutaneous routes) are in powder or concentrated liquid form and must be dissolved or diluted with WFI immediately before clinical use. Since these products enter directly into human blood or tissues, the solvent itself must be sterile and pyrogen-free.

Production of sterile active pharmaceutical ingredients (APIs): WFI is required in the final purification steps of sterile APIs, such as crystallization and washing.

Preparation of other high-purity formulations: Examples include eye drops, inhalation solutions, and certain diagnostic reagents that demand water of the highest purity.

In summary, WFI is an essential raw material and process water in the production of all parenteral (i.e., non-oral) drug products and other sterile preparations where water of the utmost purity is required.

Reference Standards for Water for Injection (WFI) in Major Global Pharmacopoeias

Parameter

United States Pharmacopeia (USP)

European Pharmacopoeia (Ph. Eur.)

Japanese Pharmacopoeia (JP)

Chinese Pharmacopoeia (ChP)

Conductivity

≤ 1.3 µS/cm @ 25°C (Stage 1)

≤1.3 μS/cm @ 25°C

≤ 1.3 µS/cm @ 25°C

≤ 1.3 µS/cm @ 25°C (Online)

TOC

≤ 500 ppb

≤ 0.50 mg/L

Microorganisms

≤ 10 CFU / 100 mL

Endotoxins

≤ 0.25 EU / mL

< 0.25 IU / mL

< 0.25 EU / mL

Nitrates

Not specified

≤ 0.2 ppm

Not specified

≤ 0.2 ppm

Heavy Metals

Not specified

≤ 0.1 ppm

Not specified

≤ 0.3 ppm

Ammonia

Not specified

≤ 0.2 ppm

Conductivity :

≤1.3 μS/cm @ 25°C

TOC :

≤500 ppb (μg/L)

Microbial Limits :

≤100 CFU/mL

Nitrates :

≤0.2 ppm

Heavy Metals :

≤0.1 ppm (as Pb)