Pharmaceutical Water - Manufacture, Monitoring & Compliance
Im Auftrag der ECA Academy

Programm

Overview of Global Pharmacopoeial Requirements and Recent Changes for Pharmaceutical Waters

• Current GMP trends and Pharmacopoeial
• requirements for pharmaceutical waters
• Requirements for Bulk Pharmaceutical Waters -
• Purified water, Highly Purified Water, WFI and
• Pure Steam
• Requirements for Sterile and packaged
• Pharmaceutical Waters
• Harmonisation and future requirements of the
• U.S., European, and Japanese Pharmacopoeias

State-of-the-art Pharmaceutical Water Generation
During the planning of a pharmaceutical water generation plant the influence of the feed water is often underestimated. A reliable and economically feasible system is only obtainable under consideration of the unique feed water chemistry. The engineering phase of the project serves to make the important decisions regarding choice of technology, such as double pass RO vs. RO combined with electrodeionization. Another question for pharmaceutical manufacturers arises from the EMEA: is the use of Highly Purified Water or treatment with Reverse Osmosis for generation of WFI-quality acceptable?

• Overview of different water treatment technologies and their suitability for pharmaceutical applications
• PW and HPW generation with membrane processes (RO/EDI)
• WFI generation with distillation
• Pure Steam Generation

Water Storage and Distribution

• Engineering details
• Water storage
• Water distribution
• Conception of Loops
• Quality attributes to measure in the loop
• Sampling issues

Modern Sanitisation Concepts

• Sanitisation with heat
• Sanitisation with chemicals (incl. Ozone)
• Combination of different methods
• Sanitisation cycles
• Sanitisation after breakdown and deviations

Required measurements in a pharmaceutical water system

• Instrumentation and monitoring for modern pharmaceutical water systems: Purpose and implementation of non-critical measurements for real-time process control, Critical measurements such as temperature, TOC, Conductivity, pressure, flow, ozone
• Current requirements in global Pharmacopoeias
• Evaluation of on-line vs. off-line measurement technologies for high purity water process control
• What you need to know: Stainless Steel: Piping and Equipment
• Composition and properties of stainless steels for water and steam systems
• Surfaces of stainless steels and their treatment
• GMP-compliant welding of piping systems
• Rouging of stainless steels: current understanding
• and strategies to deal with
• Connections, heat exchangers, valves & pumps
• Documentation and material certificates

Commissioning & Qualification of water systems (DQ-PQ)

• Risk based approach to validation of a pharmaceutical water system
• Critical components and parameters
• Modern qualification and commissioning
• Package Unit approach
• Critical timelines

Microbiological control of water systems

• Common microbial inhabitants of Pharmaceutical water systems
• Definition of “objectionable organisms” as pseudomonas
• Sources of contamination and Biofilms
• Microbiological aspects of pharmaceutical water system validation
• Routine microbiological monitoring (sampling frequency and Locations)
• Review, interpretation and reporting of microbiological data
• Handling OOS results in Pharmaceutical water systems

GMP-compliant operation of a pharmaceutical water system

• From qualification to routine operation
• Handling of deviations and changes
• Review of operating data
• Maintenance and Calibration
• Calibration cycles
• GMP-compliant log book handling
• The Water system in the Product Quality Review (PQR

)