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21 CFR PART 11 COMPLIANT MONITORING
CUSTOMISED WFI SYSTEM DESIGNS
REAL-TIME QUALITY ASSURANCE ALERTS
WATER FOR INJECTION SYSTEMS
P E D L Services Ltd delivers Water For Injection (WFI) systems engineered for the pharmaceutical and healthcare industries. These systems are critical for producing sterile injectable drugs, large-volume parenterals, and biopharma processes. Our WFI solutions ensure the highest purity by focusing on pyrogen and endotoxin removal, fully complying with USP and EP standards. Integrated monitoring guarantees continuous validation, operational reliability, and regulatory compliance throughout the system’s lifecycle.
PRE-TREATMENT AND PRIMARY PURIFICATION
WFI production begins with comprehensive pre-treatment, including water softening, filtration, and carbon beds to reduce feed water variability and protect downstream systems. Primary purification employs high-efficiency Reverse Osmosis (RO) followed by Electrodeionization (EDI) to remove bulk ions and contaminants. These stages establish the initial water purity required for further refinement, ensuring that all downstream processes meet strict regulatory and quality standards for pharmaceutical applications.
FINAL TREATMENT AND ENDOTOXIN REMOVAL
The final stage of WFI production uses Multi-Effect Distillation (MED), the gold standard for separating water vapour from non-volatile impurities and endotoxins. Alternative validated membrane systems, such as ultrafiltration trains, may also be used to consistently achieve the required endotoxin reduction. These technologies ensure the water meets the stringent purity standards necessary for injectable drugs and other sensitive pharmaceutical processes. P E D L Services Ltd delivers these WFI solutions to the pharmaceutical and biotech sector as well as laboratories, supporting sterile drug production, biopharma applications, and high-precision laboratory water requirements with full compliance and reliability.
SANITIZED DISTRIBUTION LOOP
Maintaining WFI quality is as critical as producing it. P E D L Services Ltd designs sanitary distribution loops using 316L stainless steel with orbital welding, sloped for drainage, and engineered to eliminate dead legs to prevent biofilm formation. The water is continuously circulated, stored at high temperatures, or periodically sanitised with ozone, ensuring microbial growth is prevented, and the purity achieved during production is fully maintained.
DIGITAL MONITORING, VALIDATION, AND MAINTENANCE
P E D L Services Ltd integrates advanced digital monitoring and validation systems for WFI loops. Real-time monitoring tracks temperature, conductivity, pressure, and flow, with immediate alarms for deviations. Full IQ/OQ/PQ documentation supports regulatory compliance, while cloud-based predictive maintenance analyses usage trends to schedule proactive interventions. 21 CFR Part 11 compliance ensures all electronic records are secure, audit-ready, and tamper-proof, safeguarding system reliability and validated status.
ENSURE COMPLIANCE WITH EXPERT WATER FOR INJECTION SYSTEMS
Call to discuss your WFI system needs today!
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