Are you ready for Pharma 4.0? Tips for Preparing your Water System for Real-Time Testing
GMP manufacturing and Process Analytical Technology (PAT) are the industry standards for ensuring water meets pharmaceutical grade requirements and regulations. Total organic carbon (TOC) and conductivity monitoring are two methods that ensure purified water system quality and control. The data they provide allow manufacturers to reduce waste and increase efficiency in processes from cleaning to batch processing. Pharma 4.0 is the newest operating model that combines digitalization and automation with data integrity and process control, making pharmaceutical manufacturing faster, more efficient, and safer than ever before.
In this webinar, we'll explain how to optimize purified water system quality and control with tools such as online monitoring, real-time release testing (RTRT), TOC, conductivity and Pharma 4.0; how real-time data can improve manufacturing productivity; how to confirm that your data meets regulatory requirements; and how to ensure your water remains pharmaceutical grade throughout the manufacturing process.
Learning Objectives / Topics
USP <643>, EP 2.2.44, TOC, and RTT regulations
Introduction to Pharma 4.0 for water systems
First steps and foundational components: IQ, OQ, PQ
The power of validated data for troubleshooting and diagnostics
Data integrity best practices
Lead Applications Specialist
Rohit Chakravorty is a Lead Applications Specialist with SUEZ – Water Technologies and Solutions, responsible for providing application support in India, SAARC and ASEAN region for the Sievers product line. He is responsible for helping the pharmaceutical industry become familiar with Total Organic Carbon (TOC) applications, notably in cleaning validation and Real-Time-Release-Testing (RTRT) of pharmaceutical water, and in guiding customers through successful transitions from HPLC to TOC for cleaning validation.
Prior to joining SUEZ, Rohit was an Application Specialist for India and SAARC with Sysmex, and a Research Assistant at Sun Pharmaceutical in India handling various types of scientific instrumentation.
Rohit holds a Masters in Biotechnology (Gold Medalist) from Padmashree Dr. D.Y.Patil University in India.