PSG (Pure Steam Generator) System Product Description

Product Introduction

PSG (Pure Steam Generator) system is specifically designed for high-demand applications in the biotechnology, pharmaceutical, and food industries. It provides ultra-pure sterile steam to ensure compliance with the stringent regulations of cGMP, FDA, and USP.

This system is equipped with an advanced steam generation mechanism, guaranteeing stability and reliability for sterilization, pipeline cleaning (CIP/SIP), and other aseptic operations. It is adaptable to the specific requirements of various industries, ensuring long-term stable and high-performance operation.

Product Features

• Ultra-High Purity Steam Output
  This system ensures the generation of sterile, particle-free, and chemically uncontaminated steam, strictly adhering to USP and cGMP regulations. It is suitable for production environments with stringent microbial control requirements, delivering exceptional sterilization performance.
• Compliance with USP Steam Purity Standards
  In accordance with USP <1231> standards, pure steam must be free of measurable non-condensable gases, sterile, and endotoxin-free. It should not contain condensable droplets or residues, ensuring the highest level of purity.
• Fully Automated Intelligent Control
  Equipped with an advanced PLC control system, the PSG system operates in a fully automated mode, supporting remote monitoring and data recording. This ensures stable system operation and real-time monitoring while minimizing human error.
• Optimized Heat Exchange Efficiency
  Designed with high-efficiency heat exchange technology, the system maximizes energy utilization, significantly reducing energy consumption. It enhances steam production efficiency and ensures stable operation even under high-load conditions.
• Premium Material Selection
  Key contact surfaces are made of 316L stainless steel, with internal surfaces polished to Ra ≤ 0.4µm, minimizing microbial adhesion risk. All piping components comply with ASME BPE standards, further reducing contamination risks and extending equipment lifespan.
• Modular Design & Flexible Configuration
  The system offers various capacities and configurations tailored to customer needs, ensuring optimal adaptability for different scales and application scenarios. It also supports multiple units in series or parallel operation to enhance total production capacity.
• Low Maintenance Requirements
  With an innovative design, the system minimizes maintenance frequency and operational costs, enhancing equipment lifespan and reliability.

Model & Technical Specifications

Actual specifications and pricing may vary based on customer requirements, equipment configuration, and market conditions. Please contact our technical team for the latest information.

Main Application Areas

• Pharmaceutical Industry: Extensively used in sterilization and aseptic processes within Water for Injection (WFI) systems, ensuring drug quality and production environment safety.
• Biotechnology Industry: Applied in cell culture, fermentation, and other biotechnological processes, ensuring product purity and production stability.
• Food & Beverage Industry: Suitable for sterilization, aseptic filling, and other applications requiring high-level aseptic environments.
• Cosmetics & Personal Care Manufacturing: Ensures production processes meet hygiene standards, reducing microbial contamination risks and enhancing product quality.

 Product Certifications & Compliance Standards

• 100% compliant with cGMP, FDA, USP, and EU GMP standards
• All contact materials and surface treatments comply with ASME BPE regulations
• Valves and piping systems certified according to FDA and USP Class VI standards
•   DQ/IQ/OQ documentation provided, with assistance for PQ validation to support regulatory compliance

Optional Accessories & Customization

• HMI Touchscreen Interface: Provides an intuitive and user-friendly operation and monitoring experience
• Remote Monitoring & Data Logging: Supports cloud-based monitoring and historical data analysis, improving system management efficiency
• High-Performance Heat Exchange Module: Enhances energy conversion efficiency, further reducing operational costs
• Dual Safety Valves & Pressure Monitoring Mechanism: Strengthens system safety and minimizes operational risks

For more information or customized solutions, please contact our technical team.