- Datum:
-
- Webinar
Pharmaceutical Water - Live Online Training
- Veranstaltungsort:
- online
- Veranstalter:
- CONCEPT HEIDELBERG GmbH
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, 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.
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.
- Overview of different water treatment technologies and their suitability for pharmaceutical applications
- PW and HPW generation with membrane processes (RO/EDI)
- WFI generation with and without 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
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
Technical Specialities during the Qualification of Water Systems
- 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
- The three qualification phases
- 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
- Handling of deviations and changes (examples)
- Operating data, periodic review and revalidation
- Maintenance and calibration
- GMP-compliant log book handling
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Deutschland
Telefon: +49 6221 844415
Telefax: +49 6221 844464
eMail: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
