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FDA/EU GMP Compliant | RO+EDI & Multi-Effect Distillation | Fully Automated CIP/SIP | Global Validation Support
Yangzhou PARAGON Pharmaceutical Equipment Co., Ltd., established in 2024, is a high-tech enterprise specializing in the R&D, production, and sales of pharmaceutical water systems.
Headquartered in Yangzhou, Jiangsu Province, we provide high-quality water treatment equipment and integrated solutions for the pharmaceutical, biotech, food, and chemical industries.
Our core products include Purified Water (PW) generation systems, Water for Injection (WFI) systems, pure steam generators, sanitary vessels, solution mixing systems, CIP workstations, and heat exchangers. All products comply with FDA cGMP, EU GMP, WHO GMP, and are validated under GAMP5.
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Why PARAGON is trusted by pharmaceutical manufacturers worldwide
Compliant with FDA/EU/WHO GMP standards and validated under GAMP5, ensuring global regulatory acceptance and audit readiness.
Flexible 3D modular systems optimize space utilization, reduce footprint, and enable rapid installation, maintenance, and scalability.
Full validation (RA/DQ/IQ/OQ/PQ) ensures system stability, traceability, and long-term reliability for critical pharmaceutical operations.
GMP-Compliant Pharmaceutical Water Treatment Solutions
Advanced RO+EDI technology systems meeting Chinese, EU, and US pharmacopeias. Features UV disinfection, conductivity monitoring, and fully automated control for consistent PW quality.
Prevents cross-contamination between shell and tube sides. Ideal for WFI and pure steam systems requiring high hygiene and thermal efficiency.
316L stainless steel construction with polished interior. Designed for easy CIP/SIP, ideal for storage and mixing in pharmaceutical, food, and cosmetic applications.
Closed-loop recirculating system with sanitary pumps, heat exchangers, and conductivity/TOC monitoring. Ensures consistent water quality at point of use.
Fully automated cleaning-in-place systems with Siemens PLC control. Multiple cleaning programs, temperature monitoring, and validation-ready documentation.
Efficient WFI production with multiple distillation stages and high heat recovery. Produces low conductivity, pyrogen-free water compliant with pharmacopeial standards.
EN285 compliant, 316L stainless steel construction. Delivers sterile, endotoxin-free steam for sterilization of bioreactors, filters, and process equipment.
Automated batching and mixing system with precise dosing, agitation control, and CIP capability. Ideal for media, buffer, and reagent preparation.
All PARAGON systems comply with FDA cGMP, EU GMP, WHO GMP, and relevant pharmacopeial standards (USP, EP, CP). Systems are designed and validated under GAMP5 guidelines.
Yes, we provide full validation support including Risk Assessment (RA), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and summary reports.
All wetted parts are constructed from 316L stainless steel with electropolished surfaces (Ra ≤ 0.4 μm). Diaphragm valves and seals are EPDM or PTFE as required.
Absolutely. Our modular design approach allows customization of flow rates, automation level, instrumentation, and footprint to meet specific facility and process needs.
Contact PARAGON for technical inquiries, quotations, or validation support.
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