Pharmaceutical & Healthcare
Ultra-pure water systems meeting stringent USP and regulatory requirements for pharmaceutical manufacturing. Complete solutions for PW, WFI, and clean utility systems.
Key Features & Benefits
USP Compliance
Systems designed and validated to meet USP, EP, and IP monograph standards for pharmaceutical water.
WFI Generation
Multiple-effect distillation and hot water sanitizable RO systems for Water for Injection production.
Validation Support
Complete IQ/OQ/PQ documentation and validation protocols for regulatory submissions.
Sanitization Systems
Automated thermal and chemical sanitization cycles maintaining microbiological control.
cGMP Compliance
Design and documentation meeting current Good Manufacturing Practice requirements.
21 CFR Part 11
Electronic records and signatures compliant with FDA regulations for pharmaceutical systems.
Pharmaceutical Water Systems Excellence
Ionic Engineering delivers comprehensive pharmaceutical water systems that meet the most stringent quality and regulatory standards. Our solutions encompass Purified Water (PW), Water for Injection (WFI), and Clean Steam generation systems designed specifically for pharmaceutical and healthcare applications.
Our pharmaceutical water treatment systems integrate advanced technologies with stringent quality controls:
- Multi-stage pre-treatment with multimedia filtration and activated carbon
- Two-pass RO systems with hot water sanitization capability
- Electrodeionization (EDI) for continuous high-purity water production
- Storage and distribution loops with UV disinfection and 0.2-micron filtration
Water for Injection (WFI) Systems
Our Water for Injection systems utilize both traditional multiple-effect distillation and modern hot water sanitizable membrane technologies. These systems produce pyrogen-free water meeting USP <1231> specifications with endotoxin levels below 0.25 EU/mL, essential for parenteral drug manufacturing and medical device processing.
We offer comprehensive WFI solutions including , hot water generation loops maintained at 80-85°C, and clean steam generators for sterilization applications.
Our WFI systems include:
- Multiple-effect vapor compression stills (2 to 6 columns)
- Hot water sanitizable RO-EDI systems (membrane-based WFI)
- WFI storage tanks with heat maintenance and CIP capability
- Distribution loops with controlled turbulent flow and sanitary fittings
Validation & Regulatory Compliance
All pharmaceutical water systems are delivered with comprehensive validation documentation including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. Our systems meet FDA, EMA, and WHO guidelines with full traceability and audit trail capabilities.
We provide ongoing validation support, change control procedures, annual product quality reviews, and assistance with regulatory inspections to ensure continuous compliance throughout the system lifecycle.
Clean-in-Place (CIP) Systems
Our automated CIP systems ensure consistent cleaning and sanitization of pharmaceutical water systems, process equipment, and distribution loops. These systems feature programmable cleaning cycles, chemical concentration monitoring, conductivity tracking, and complete batch records for regulatory compliance.
Pharmaceutical Project Gallery
Why Choose Ionic for Pharmaceutical Projects
Regulatory Expertise
Extensive experience with FDA, EMA, WHO, and global regulatory requirements ensuring systems meet current cGMP and validation standards.
Validated Systems
Complete validation packages with IQ/OQ/PQ protocols, SOPs, and documentation ready for regulatory submissions and inspections.
Quality Materials
316L stainless steel construction, sanitary fittings, and USP Class VI certified components ensuring product contact safety and durability.
Microbiological Control
Advanced sanitization protocols, UV disinfection, ozonation, and hot water loops maintaining microbiological specifications consistently.
Automation Excellence
21 CFR Part 11 compliant control systems with electronic signatures, audit trails, and comprehensive data logging for regulatory compliance.
Lifecycle Support
Ongoing technical support, preventive maintenance programs, revalidation services, and spare parts availability throughout system lifecycle.
Ready to Discuss Your Project?
Our experts are ready to help you find the perfect water treatment solution for your pharmaceutical & healthcare needs
Get in touch with our experts
Have a custom requirement? Book a free consultation with our engineering team or drop us a message.
Contact Information
Call Us
020-27475272/73
020-29525874
+91 82754 86263
Mon-Sat, 9:30 AM to 6:30 PM
Visit HQ
S. No. 1, 5, 11-13, B Wing,
Mahalaxmi Heights, Mumbai-Pune Rd,
Pimpri, Pune-18, MH, INDIA.