Water Filtration System for raw materials, solvents, and wastewater

The pharmaceutical industry relies heavily on advanced filtration technologies for the purification and separation of raw materials, solvents, and wastewater. Filtration ensures product quality, safety, and regulatory compliance. Below are key filtration applications across various pharmaceutical processes, along with detailed filtration steps and products involved.

1. Active Pharmaceutical Ingredient (API) Production

Application: Purification and separation of active pharmaceutical ingredients (APIs) such as antibiotics and hormones.

Filtration Goals: Removal of particles (≤0.2 µm), microorganisms (e.g., bacteria, viruses), and pyrogens (endotoxins).

Technical Solution:

· Depth Filter: Pre-filters(bag/cartridges filters) large particles (1–10 µm) to protect downstream equipment.

· Microfiltration Membranes (MF): Pore size 0.1–0.2 µm, for removing microorganisms and pyrogens.

· Ultrafiltration Membranes (UF): Retain molecules in the range of 10–100 kDa, separating proteins and polysaccharides.

Case Study: A pharmaceutical company used a combination of depth filtration and ultrafiltration to improve the purity of their APIs from 95% to 99.9%.

Filtration Process:

1. API solution → Depth filter(bag/cartridges filters) → Microfiltration → Ultrafiltration → Final API.

2. Water for Injection (WFI) Preparation

Application: Production of high-purity water for injections and infusions, meeting USP, EP, and JP standards.

Filtration Goals: Achieve TOC ≤500 ppb, conductivity ≤1.3 µS/cm, and endotoxins ≤0.25 EU/mL.

Technical Solution:

· Reverse Osmosis (RO): Desalination rate ≥99%, removes ions and organic substances.

· Ultrafiltration (UF): Removes bacteria and pyrogens.

· Ultraviolet (UV) Sterilization: Wavelength 254 nm, inactivates microorganisms.

Equipment: Multi-effect distillation (MED) units, Electro-deionization (EDI) systems.

Filtration Process:

1. Water → Reverse Osmosis → Ultrafiltration → UV Sterilization → Water for Injection.

3. Biopharmaceuticals and Vaccine Production

Application: Filtration and concentration of monoclonal antibodies, vaccines, and cell culture liquids.

Filtration Goals: Removal of cell debris (0.1–10 µm), viruses (20–200 nm), and impurities.

Technical Solution:

· Tangential Flow Filtration (TFF): Concentrates proteins, with a recovery rate ≥95%.

· Virus Filters: Pore size 20–50 nm, ensuring a virus removal rate ≥99.99%.

· Sterile Filters: Pore size 0.2 µm, ensuring sterile filling.

Industry Standards: Compliance with FDA 21 CFR Part 211 and EMA GMP guidelines.

Filtration Process:

1. Cell culture liquid → Tangential flow filtration → Virus filtration → Sterile filtration → Final product.

4. Oral Liquid and Syrup Filtration

Application: Filtration of oral liquids, syrups, and suspensions for clarification and sterilization.

Filtration Goals: Removal of particles (≤0.45 µm), microorganisms, and precipitates.

Technical Solution:

· Bag Filters: Pre-filtration(bag/cartridges filters) of large particles (10–50 µm).

· Microfiltration Membranes (MF): Pore size 0.2–0.45 µm for product clarity.

· Activated Carbon Filters: Adsorption of colorants and odors.

Case Study: A pharmaceutical company extended the shelf life of its oral liquids to 24 months using a combination of bag filters and microfiltration.

Filtration Process:

1. Oral liquid → Bag filter → Microfiltration → Activated carbon filtration → Final product.

5. Solvent and Cleaning Liquid Filtration

Application: Filtration of solvents for pharmaceutical equipment cleaning and solvent recovery.

Filtration Goals: Removal of particles (≤1 µm), microorganisms, and organic contaminants.

Technical Solution:

· Stainless Steel Sintered Filter Cartridges: Corrosion-resistant, pore sizes of 1–10 µm.

· Molecular Sieve Dehydration Systems: Dehydrates solvents to achieve a dew point of ≤-40°C, ensuring effective cleaning.

· Self-Cleaning Filters: Automates cleaning, reducing downtime.

Filtration Process:

1. Solvent or cleaning liquid → Stainless steel filter → Molecular sieve system → Cleaned solvent.

6. Wastewater Treatment and Reuse

Application: Treatment and reuse of pharmaceutical wastewater containing antibiotics, hormones, and organic solvents.

Filtration Goals: COD ≤100 mg/L, Suspended solids ≤10 mg/L, Heavy metals ≤0.1 ppm.

Technical Solution:

· Membrane Bioreactor (MBR): Removes organic matter and suspended solids, with a flux rate ≥20 LMH.

· Reverse Osmosis (RO): Desalination rate ≥98%, enabling wastewater reuse.

· Activated Carbon Adsorption: Removes residual pharmaceuticals and organic contaminants.

Compliance: Meets China’s Pharmaceutical Industry Water Pollution Discharge Standards (GB 21904-2008).

Filtration Process:

1. Pharmaceutical wastewater → Membrane bioreactor → Reverse osmosis → Activated carbon adsorption → Reused water.

Other Pharmaceutical Filtration Applications:

· Sterile Filtration: Ensures sterility in injectable products using 0.2 µm sterile filters.

· Protein Purification: Using affinity chromatography filters to purify monoclonal antibodies and proteins.

· Gas Filtration: Removes particulates and microorganisms from process gases in manufacturing lines using high-efficiency gas filters.