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Pharmaceutical

Pharmaceutical manufacturing uses water as both a raw ingredient and a critical cleaning agent. USP Purified Water and Water for Injection (WFI) standards exist because water quality directly affects drug safety and efficacy — trace endotoxins, dissolved ions, or microbial contamination in process water can compromise an entire production batch and trigger regulatory action. The standard is not advisory; it is a compliance requirement enforced through FDA, EMA, and WHO inspection programs.

USP Purified Water requires a total organic carbon (TOC) level below 500 ppb, conductivity below 1.3 µS/cm at 25°C, and a microbial limit of 100 CFU per milliliter. Water for Injection — used in parenteral formulations and in equipment cleaning that contacts injectable products — holds a tighter microbial limit of 10 CFU per 100 milliliters, with endotoxin below 0.25 EU/mL. Meeting these specifications consistently requires a validated treatment system with documented process control, regular testing, and periodic re-validation after any system modification.

AMPAC USA designs and manufactures ultrapure water systems for pharmaceutical and biotechnology manufacturing. Treatment sequences are engineered to the specific product type and production volume, typically incorporating softening, activated carbon filtration, two-pass RO, electrodeionization, and ultrafilter polishing. Systems are designed with FDA 21 CFR Part 11 compatibility where electronic records and audit trails are required. Documentation packages include instrument calibration records, factory acceptance testing data, and installation qualification support.

For facilities seeking to add or upgrade water purification capacity ahead of an FDA inspection or product launch, AMPAC provides accelerated procurement and delivery timelines. AMPAC also supplies replacement membranes, EDI modules, and cartridge elements for existing systems to maintain continuous compliance.

Contact AMPAC USA at (909) 548-4900 to discuss USP water system design, validation documentation, or equipment sourcing for your manufacturing operation.