The Center for Professional Innovation & Education (CfPIE), Dublin, Ireland
Apr. 19 & 20, 2007
Who Should Attend Successful specification, design, installation, validation, management and control of a pharmaceutical water system depends on a coordinated, multi-disciplinary approach. The course will be valuable for those in pharmaceutical, biotechnology and medical device manufacturing who are responsible for or involved in: • Specification and engineering design
• Technical and validation support
• Regulatory compliance activities and auditing
• Risk assessment, troubleshooting and system improvement
• Water system operation, management and maintenance
• Quality assurance and validation management
• Quality control, sampling, microbiological and chemical analysis Learning Objectives Upon completion of this course you will: • Understand the water types, qualities, uses and applications in pharmaceuticals, biotechnology and medical device manufacture
• Be familiar with the applications and limitations of the range of treatment technologies and able to choose the most effective combination of techniques for your needs
• Appreciate the importance of a “common-sense” approach to the implementation of cost-effective design solutions
• Be aware of the GMP requirements and regulatory expectations relating to water systems and their validation requirements
• Have gained a practical understanding of systems via examples and discussions
• Have developed better knowledge and understanding between the different disciplines involved in the operation and management of water systems The course will also provide a discussion forum to exchange ideas and experience and to learn from each other. Course Description An interactive mix of lectures and discussions highlight basic principles and technologies, and how these are applied in practice to pharmaceutical water systems. The course is intended to raise practical understanding and awareness for water system owners, managers, QA managers, regulatory compliance staff, microbiologists, engineers, validation specialists and operators.
COURSE AGENDA
DAY ONE The Basic Chemistry and Microbiology of Water • The water molecule and hydrogen bonding
• Physical and chemical characteristics
• Types of contaminants found in water
• Microbiological concerns Overview of unit operations • Filtration
• Activated carbon
• Membrane technologies: micro-, ultra-, nano-filtration and reverse osmosis
• Softening
• Ion exchange
• Electrodeionisation
• Distillation
• UV Product Water Qualities • Potable Water
• Purified Water
• Water for Hemodialysis
• Highly Purified Water
• Water for Injection
• In-house qualities
• Contamination limits
• USP and European Regulatory Standards
• International standards and harmonization strategies
• Guidance from USP and EMEA Specification and Design • Design strategy
• Multidisciplinary approach
• Defining user requirements
• Design criteria: best practices
• Design for microbiological control
• “Deadlegs”, crevices, surface finish and biofilm Materials of Construction • Plastic materials
• “Utility” plastics: Polypropylene, PVC and, ABS
• Advanced polymers: PVDF and PFA
• Gaskets and seals: PTFE, silicone, EPDM, perfluoroelastomers
• Stainless steel – metallurgy, surface finish, welding, passivation and corrosion control
• Chemical and heat resistance
• Effects on water quality: extractables
• CFR permitted materials Feedwater Considerations and Pre-treatment Options • Groundwater vs. surface water
• Suspended solids and colloids
• Hardness
• Organic contamination
• Sanitant – chlorine or chloramines? Final Treatment and Polishing • Ion exchange vs. membrane technologies
• Multi-effect and vapor-compression stills
• Techniques for Purified Water and WFI
• Recent advances in technology
DAY TWO
Storage and Distribution • System Components and Architecture
• Hygienic Design and Construction
• Hydraulic design and flow control
• Storage temperature options and sanitization strategies
• Point-of-use design
• Installation and quality control
• Novel technologies Sampling and Testing • Sampling for chemical and microbiological analysis
• Conductivity
• Total organic carbon
• Nitrates and heavy metals
• Total viable count
• Objectionable organisms
• Endotoxin analysis - LAL
• Rapid microbiological assay technologies
• On-line monitoring and process control System Management and Maintenance • Operational parameters
• Standard operating procedures
• Sanitization methods
• Sampling and testing routines
• Data collection, trending and interpretation
• Action and alert limits
• How to manage OOS results
• Data review and summary
• Preventative and predictive maintenance
• Maintenance schedules and records
• Troubleshooting Pharmacopoeial, GMP and Compliance Issues • United States and European Pharmacopoeial Monographs and Guidelines
• US and European GMPs
• Current and emerging regulatory requirements
• Regulatory expectations and concerns
• Inspection strategies – FDA vs. EMEA
• Mutual Recognition Agreement
• Auditing to improve compliance Validation and Qualification • Regulatory requirements and guidelines
• Validation Master Plan
• DQ, IQ, OQ and PQ
• The validation envelope
• Protocol design
• Commissioning vs. OQ
• PQ schemes
• Change control and revalidation Regulations and Guidelines • CFR21 parts 210 and 211
• European GMPs
• Regulatory guidelines: FDA, USP, EMEA and ICH
• Industry guidelines: PDA, ISPE and ASME
• Suggestions for further reading… Discussion Forum
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