by Dr. Yashashwini Reddy | Sep 15, 2025
Guide to Inspections of High Purity Water Systems 1. Introduction High Purity Water (HPW) systems, including Purified Water (PW), Water for Injection (WFI), and Highly Purified Water (HPW), are critical utilities in pharmaceutical manufacturing. Regulatory agencies...
by Dr. Yashashwini Reddy | Sep 13, 2025
1. System Design & Validation Water system (Purified Water, WFI, Potable Water) designed to meet pharmacopeial requirements (USP/EP/IP/JP). System qualification performed (DQ, IQ, OQ, PQ) with proper documentation. Risk assessment performed for potential...
by Dr. Yashashwini Reddy | Aug 27, 2025
Biofilm Removal and Chemical Sanitization of RO Systems 1. Introduction RO membranes in pharmaceutical water systems (Purified Water / WFI) are prone to biofilm formation due to microbial contamination and nutrient accumulation. Biofilm is a slimy matrix of...
by Dr. Yashashwini Reddy | Aug 27, 2025
Activated Carbon Filter in Water System 1. Introduction Activated Carbon (AC) filters are widely used in Purified Water (PW) and Water for Injection (WFI) pre-treatment systems.They are installed after multimedia filters and before softeners/RO systems. Main function:...
by Dr. Yashashwini Reddy | Aug 27, 2025
Purified Water Storage and Distribution System in Pharmaceuticals Purified water is a critical utility in pharmaceutical manufacturing, widely used in formulations, cleaning, rinsing, and as a raw material. A robust storage and distribution system ensures that water...
