Stainless Steel RO Water Treatment for Pharma

Product Overview

Stainless Steel RO Water Treatment for Pharma is a high-purity water purification system tailored to meet the stringent requirements of pharmaceutical manufacturing. Built with 316L stainless steel (the gold standard for sanitary pharmaceutical equipment), this system utilizes Reverse Osmosis (RO) technology to remove impurities, microorganisms, and dissolved solids from feedwater, producing water that complies with USP Purified Water (PW) and EP Grade 2 Water standards. The core RO membrane (typically Dow BW30-4040 or Hydranautics ESPA2) achieves a salt rejection rate of 99.5% and a total organic carbon (TOC) removal rate of >98%, ensuring the final water meets the low conductivity requirement of <5 μS/cm (at 25°C). Integrated with pre-treatment (sand filtration, activated carbon) and post-treatment (UV disinfection, ultrafiltration) modules, this system provides a continuous, reliable supply of high-purity water for critical pharmaceutical processes.

Product Features

• GMP-Compliant Sanitary Design: All wetted parts are polished to a Ra < 0.8 μm surface finish, with seamless welding (per ASME BPE standards) to eliminate dead zones and prevent microbial growth. Quick-disconnect fittings also facilitate easy disassembly for cleaning.

• High-Efficiency RO Membrane System: The dual-stage RO configuration (primary + secondary) boosts water recovery rate to 75–85% (vs. 50–60% for single-stage systems), reducing water waste and operational costs. Membrane life is extended to 2–3 years via an automatic flushing cycle (triggered after 2 hours of inactivity).

• Intelligent Automation Control: Equipped with a PLC (Programmable Logic Controller) and HMI (Human-Machine Interface), the system enables real-time monitoring of key parameters (conductivity, pressure, flow rate) and automatic adjustment of operating conditions. Remote access via SCADA is also available for centralized management.

• CIP (Clean-in-Place) Functionality: A built-in CIP module uses 0.5–1% sodium hydroxide or citric acid solution to clean the RO membrane and pipelines, with programmable cycles (30–60 minutes) that eliminate manual cleaning and reduce cross-contamination risks.

• Robust Material Durability: The frame is made of 304 stainless steel (powder-coated for rust resistance), and all valves (ball valves, check valves) are constructed from 316L stainless steel with EPDM (ethylene propylene diene monomer) seals, ensuring compatibility with pharmaceutical cleaning agents.

Applications

• Injectable Drug Production: Provides USP Water for Injection (WFI) pre-treatment, removing particulates and dissolved salts before final distillation, critical for ensuring the safety of intravenous (IV) medications.

• Oral Solid Dosage (OSD) Manufacturing: Supplies purified water for granulation, coating, and tablet washing processes, preventing impurities from affecting drug stability or bioavailability.

• Biopharmaceutical Processes: Used in cell culture media preparation and bioreactor feeding, with ultrafiltration post-treatment to remove endotoxins (<0.25 EU/mL) and ensure compliance with bioprocessing standards.

• Aseptic Packaging: Delivers high-purity water for cleaning and rinsing of ampoules, vials, and blister packs, reducing microbial counts to <1 CFU/mL (per FDA guidelines) before product filling.

FAQ

Q1: Can the system adjust to fluctuating feedwater quality (e.g., high hardness)?

A1: Yes. The pre-treatment module includes a water softener (with ion exchange resin) to reduce hardness (<50 mg/L as CaCO₃) and a scale inhibitor dosing pump (dosing rate: 1–5 ppm), preventing membrane scaling even with variable feedwater conditions.

Q2: What is the maximum water production capacity of the system?

A2: Standard models range from 1 m³/h to 100 m³/h, with modular designs allowing parallel installation of multiple systems for capacities exceeding 100 m³/h (e.g., for large-scale API manufacturing plants).

Q3: How is the system validated for pharmaceutical use?

A3: We provide a comprehensive Validation Package, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, along with documentation of membrane performance and water quality test reports (per USP <645> and <643>).

Q4: Does the system require specialized operator training?

A4: Basic training (2–4 hours) is sufficient for routine operation, as the HMI features intuitive controls and alarm prompts. We also offer on-site training and 24/7 technical support for complex troubleshooting.