Pharmaceutical

USP defines Purified Water for non-sterile applications with conductivity below 1.3 microsiemens per centimeter at 25 degrees C, Water for Injection with the same conductivity limit plus endotoxin below 0.25 EU/mL for parenteral use, and Highly Purified Water as a European Pharmacopoeia category between the two. The appropriate category depends on the application: oral dosage forms use Purified Water, while sterile injectables require WFI. AMPAC USA builds systems for all USP water types with appropriate documentation for regulatory submission.

USP Chapter 1231 recognizes distillation and membrane-based methods including reverse osmosis combined with ultrafiltration as acceptable for WFI production. The membrane route requires multistage RO, electrodeionization, and 10,000 MWCO ultrafiltration to achieve consistent endotoxin levels below 0.25 EU/mL with bacterial counts below 10 CFU/100mL. Our WFI systems are designed with the continuous recirculation loops, hot sanitization capability, and sample ports required for cGMP-compliant operation.

We provide design qualification documents, material certifications with USP Class VI or ISO 10993 biocompatibility data for wetted components, weld logs and boroscope records for orbital welds in stainless distribution systems, and factory acceptance test data for all system parameters. Site qualification support is available including IQ protocol execution, OQ test execution with witnessed data, and PQ support for extended performance demonstration periods. Our technical file is formatted for both US Drug Master File submissions and EU Technical Documentation.

Electrodeionization is a continuous ion removal process using ion exchange resin beds regenerated electrically rather than chemically, eliminating the need for acid and caustic regeneration chemicals in the polishing stage. EDI following RO consistently achieves resistivity above 18 megohm-cm and TOC below 50 ppb without the batch regeneration downtime of traditional mixed-bed DI. For pharmaceutical operations under cGMP, the elimination of regeneration chemical handling also reduces safety risk and chemical documentation burden.

A standard Purified Water system includes multimedia filtration, a water softener, 5-micron cartridge filtration, double-pass RO, EDI, and a 0.2-micron final filter before the distribution loop. The storage and distribution loop recirculates continuously through a UV unit at 40,000 microwatt-seconds per square centimeter with use-point drop pipes terminated in self-draining valves. AMPAC USA integrates PLC controls with 21 CFR Part 11 compliant data acquisition for all critical process parameters, alarm history, and sanitization cycle documentation.