GMP-Compliant Purified Water Equipment for Pharmaceutical Industry

The water quality meets the requirements of the 2000 edition of the Chinese Pharmacopoeia and all provisions of GMP. The equipment operates fully automatically and includes conditionally fully automated treatment procedures (such as backwashing, regeneration, acid washing, and disinfection). Individual units and piping meet GMP requirements (e.g., downstream treatment equipment such as sterilizers, membrane filters, terminal water tanks, and piping all use 316L stainless steel; pretreatment equipment piping uses UPVC pipes).

Purified Water Quality Standards:

Resistivity: ≥0.5 MΩ·cm, Conductivity: ≤2 μS

Ammonia ≤0.3 μg/ml

Nitrate ≤0.06 μg/ml

Heavy Metals ≤0.5 μg/ml

Typical Pharmaceutical Pure Water Preparation Process Flow:

Raw water – Raw water booster pump – Multi-media filter – Activated carbon filter – Water softener – Precision filter – First-stage reverse osmosis – pH adjustment – Intermediate water tank – Second-stage reverse osmosis (reverse osmosis membrane surface is positively charged) – Purified water tank – Pure water pump – Ultraviolet sterilizer – Microfiltration filter – Point of use Recommended new process

Raw water – Raw water booster pump – Multi-media filter – Activated carbon filter – Water softener – Precision filter – First-stage reverse osmosis equipment – Intermediate water tank – Intermediate water pump – Ion exchanger – Purified water tank – Pure water pump – Ultraviolet sterilizer – Microfiltration filter – Point of use Traditional process

Raw water – Raw water booster pump – Multi-media filter – Activated carbon filter – Water softener – Precision filter – First-stage reverse osmosis unit – Intermediate water tank – Intermediate water pump – EDI system – Purified water tank – Pure water pump – Ultraviolet sterilizer – Microfiltration filter – Point of use New process