Design of Purified Water and Water For Injection （纯化水和注射用水的设计）.pdfVIP

Design of Purified Water and Water For Injection Systems Hugh Hodkinson Engineers Ireland Chemical Process Division Introduction • My Background • What’s this lecture about • What should you get out of it - Learn basic design rules for PUW WFI - Understand where they came from - Know enough to query a design What are PUW and WFI • Compendial Waters as classified by national and international organisations such as: • United States Pharmacopoeia (USP) • European Pharmacopoeia (Ph. Eur) • Japanese Pharmacopoeia (JP) What are PUW and WFI used for • Product contact operations • Typical PUW uses: • Bulk API or BPC Preparation • Non parenteral dosage forms • Laboratory activities • Cleaning of the above and initial rinses for the below • Typical WFI uses: • Sterile Bulk API or BPC Preparation • Parenteral dosage forms • Final cleaning rinses for the above two applications Purified Water Parameter Unit USP Ph. Eur. (Bulk TOC ppb C 500 500 Conductivity µS/cm @ 20 °C - ≤ 4.3 Conductivity µS/cm @ 25 °C ≤ 1.3 - Nitrate (NO3) ppm - ≤ 0.2 Heavy Metals ppm as Pb - ≤ 0.1 Aerobic Bacteria CFU/ ml ≤ 100 ≤ 100 Water For Injection Parameter Unit USP Ph. Eur. (Bulk TOC ppb C ≤ 500 ≤ 500 Conductivity µS/cm @ 20 °C - ≤ 1.1 Conductivity µS/cm @ 25 °C ≤ 1.3 - Nitrate (NO3) ppm - ≤ 0.2 Aerobic Bacteria CFU/ 100 ml ≤ 10 ≤ 10 Bacterial EU/ ml ≤ 0.25