Pharmaceutical Purified Water Equipment

**Binrun Environmental Protection Company: Setting the Industry Benchmark for Biopharmaceutical Purified Water Equipment with ISO Certification and Innovative Technology**

In the biopharmaceutical field, the water quality of purified water equipment directly affects the safety and efficacy of vaccines, biologics, and gene therapy products. As a **3A-level integrity enterprise** based in Wuhan, Binrun Environmental Protection Company (hereinafter referred to as "Binrun") relies on the strict quality control of **ISO system certification**, the innovative strength of **patented technology**, and the outstanding reputation of **being a Grade A taxpayer for six consecutive years**. It specializes in providing high-precision, low-endotoxin purified water system solutions for the biopharmaceutical industry, helping companies pass international authoritative certifications such as FDA and EMA.

 **1. ISO System Certification: Global Compliance Assurance for Biopharmaceutical Water**
Binrun strictly adheres to the ISO 9001 quality management system and GMP standards, meeting the stringent requirements of the biopharmaceutical industry from design to operation and maintenance:
- **R&D and Design**: Modular, dead-space-free structural design with materials compliant with ASME BPE standards, eliminating the risk of biofilm formation and meeting the needs of processes such as cell culture and antibody purification.
- **Production Validation**: Core components use original imports (e.g., Swiss ABB sensors, German Siemens PLC). The system passes 3Q validation (DQ/IQ/OQ) and supports FDA audits and data integrity requirements (21 CFR Part 11).
- **Water Quality Assurance**: The produced water meets the ultrapure water standards of the *Chinese Pharmacopoeia* and *United States Pharmacopeia (USP)*, with endotoxin levels ≤0.001 EU/mL and resistivity ≥18.2 MΩ·cm.

 **2. Patented Technology: Addressing Core Challenges in Biopharmaceutical Purified Water**
Binrun's independently developed **Biopharmaceutical-Grade Purified Water Equipment (BR-Pro Series)** focuses on high-frequency industry needs, empowering industrial upgrades through technology:
1. **Multi-Stage Purification + Ultrafiltration System**: Integrates dual-stage RO reverse osmosis, EDI electrodeionization, and ultrafiltration processes to efficiently remove endotoxins, nucleases, and other biological contaminants, ensuring water quality meets the requirements for cell therapy and gene drug production.
2. **Fully Enclosed Circulation System**: Utilizes 316L stainless steel double-tube sheet welding technology, equipped with TOC online monitoring and ozone disinfection modules to prevent secondary contamination and ensure continuous stability of the water system.
3. **Digital Management Platform**: Real-time monitoring of water quality, energy consumption, and equipment status via the SCADA system, with cloud-stored traceable data, helping companies achieve intelligent and low-carbon production goals.

 **3. Integrity as the Foundation: 3A-Level Enterprise Safeguarding Biopharmaceutical Supply Chain Security**
As a **Grade A Taxpayer Credit Unit** and **3A-Level Integrity Enterprise**, Binrun has become a long-term trusted partner for biopharmaceutical companies through transparent services and full lifecycle commitments:
- **Compliance and Transparency**: Provides complete validation documents (FAT/SAT) from design to delivery, meeting NMPA and FDA submission requirements.
- **Rapid Response**: With headquarters in Wuhan Optics Valley and Shanghai Pudong, it serves nationwide. A 24-hour technical team provides support, with emergency fault responses within 4 hours, minimizing production interruption risks.
- **Long-Term Collaboration**: Offers customized maintenance services and regular system performance upgrades to match companies' expansion and process iteration needs.

 **4. Industry Empowerment: Focus on Biopharmaceutical Application Scenarios**
Binrun's purified water systems have been successfully applied in vaccine production, monoclonal antibody R&D, CGT (cell and gene therapy), and other fields:
- **Vaccine Production**: Provides ultrapure water systems for COVID-19 vaccine manufacturers, with water quality passing WHO pre-certification and supporting tens of millions of doses of production capacity.
- **Biologics**: Purified water systems are used for bulk drug substance preparation of antibody drugs, ensuring protein activity and batch consistency.
- **Green Recycling**: Equipped with WFI (Water for Injection) recovery devices, increasing water utilization to 85% and reducing the environmental pressure on biopharmaceutical companies.

 **Choose Binrun, Choose the Gold Standard for Biopharmaceutical Water**
Binrun Environmental Protection Company, rooted in **ISO international certification**, driven by **patented technology**, and connected through **integrity services**, continues to provide compliant, efficient, and intelligent purified water systems for biopharmaceutical companies. We sincerely invite industry partners to join hands in safeguarding the life and health industry with cutting-edge water technology!