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as of 2019 - 05 - 07
5 Pharmaceutical Water
5.A Water qualities
Summary
5.A.1 Overview
5.A.2 Drinking water as source water
5.A.2.1 Drinking water quality requirements
5.A.3 Purified water
5.A.3.1 Production and use
5.A.3.2 Quality requirements
5.A.3.3 Purified Water in containers
5.A.4 Highly Purified Water (HPW)
5.A.4.1 Production and use
5.A.4.2 Quality requirements
5.A.5 Water for Injections (WFI)
5.A.5.1 Production and use
5.A.5.2 Quality requirements
5.A.5.3 Sterilised Water for Injections
5.A.6 Clean steam
5.A.6.1 Production and use
5.A.6.2 Quality requirements
5.B Pharmaceutical Water Generation
Summary
5.B.1 Introduction
5.B.2 Important aspects of pharmaceutical water generation
5.B.3 Processes for generating different water qualities
5.B.3.1 Purified Water (PW)
5.B.3.2 Highly Purified Water (HPW)
5.B.3.3 Water for Injections (WFI)
5.B.4 Pre-treatment (conditioning) processes
5.B.4.1 Filtration
5.B.4.2 Chemical stabilisation
5.B.4.3 Removal of chlorine
5.B.4.4 UV irradiation
5.B.4.5 Softening using ion exchange
5.B.5 Total desalination using ion exchange
5.B.5.1 Design and function
5.B.5.2 Evaluating the process
5.B.6 Reverse osmosis (RO)
5.B.6.1 Functional principle
5.B.6.2 Membranes
5.B.6.3 Design of a reverse osmosis system
5.B.6.4 Operating a reverse osmosis system
5.B.6.5 Evaluating the process
5.B.7 Degassing
5.B.8 Electro-deionisation (EDI)
5.B.8.1 Functional principle
5.B.8.2 EDI system design
5.B.8.3 Evaluating the process
5.B.9 Ultrafiltration (UF)
5.B.9.1 Functional principle
5.B.9.2 Design and operation of an ultrafiltration system
5.B.9.3 Evaluating the process
5.B.9.4 Is ultrafiltration suitable for producing WFI?
5.B.10 Distillation
5.B.10.1 Functional principle
5.B.10.2 Design and operation of a distillation system
5.B.10.3 Distillation process
5.B.10.4 Single-stage distillation systems
5.B.10.5 Multi-stage distillation systems
5.B.10.6 Thermal compression systems
5.B.11 Manufacture of WFI using membrane technology
5.B.11.1 Rapid testing methods for monitoring the system
5.C Distribution and storage of pharmaceutical water
Summary
5.C.1 Types of storage
5.C.1.1 Cold storage
5.C.1.2 Hot storage
5.C.2 Distribution
5.C.2.1 Branch-line system
5.C.2.2 Closed loop system
5.C.2.3 Parallel pipeline systems
5.C.2.4 Central distribution loops
5.C.2.5 Systems with hot storage
5.C.3 Planning and design
5.C.3.1 Engineering
5.C.3.2 Hydraulic design
5.C.4 Technical equipment
5.C.4.1 Pharmaceutical design
5.C.4.2 Containers
5.C.4.3 Pumps
5.C.4.4 Heat exchangers
5.C.4.5 Ozone generators
5.C.4.6 UV radiators
5.C.4.7 Valves
5.C.4.8 Pipe connections
5.C.4.9 Pipes and pipe fittings
5.C.4.10 Standards
5.C.5 Systems made of PVDF
5.C.5.1 Principles
5.C.5.2 Welding of PVDF
5.C.6 Measurement equipment
5.C.6.1 Fill level measurement
5.C.6.2 Flow measurement
5.C.6.3 Conductivity measurement
5.C.6.4 Pressure measurement
5.C.6.5 Temperature measurement
5.C.6.6 Ozone measurement (online)
5.C.6.7 TOC measurement (online)
5.D Qualification of water supply systems
Summary:
5.D.1 Introduction
5.D.2 Official requirements
5.D.2.1 Europe
5.D.2.2 USA
5.D.2.3 International
5.D.3 Design qualification
5.D.3.1 User requirements specification
5.D.3.2 Functional specification
5.D.3.3 Risk analysis of an pharmaceutical water system
5.D.3.4 DQ plan and report
5.D.4 Installation qualification (IQ)
5.D.4.1 Technical documentation
5.D.4.2 Standard operating procedures (SOPs)
5.D.4.3 IQ plan and report
5.D.5 Operational qualification (OQ)
5.D.5.1 Operator training
5.D.5.2 OQ plan and report
5.D.5.3 Handover to the operator
5.D.6 Performance qualification (PQ)
5.D.6.1 Phase I
5.D.6.2 Phase II
5.D.6.3 Phase III
5.D.6.4 Microbiological testing of pharmaceutical water
5.D.6.5 Action and warning limits
5.D.6.6 PQ plan and report
5.D.7 Sample documents
5.D.7.1 User requirements specification
5.D.7.2 Functional specification
5.D.7.3 Risk analysis (extract)
5.D.7.4 Design qualification: Plan
5.D.7.5 Design qualification: test record
5.D.7.6 Design qualification: Report
5.D.7.7 Installation qualification: Plan
5.D.7.8 Installation qualification: Report
5.D.7.9 Training
5.D.7.10 Operational qualification: Plan
5.D.7.11 Operational qualification: Report
5.D.7.12 Handover
5.D.7.13 Performance qualification: Plan
5.D.7.14 Performance qualification: Intermediate report
5.D.7.15 Performance qualification: Final report
5.E Operation and maintenance of water systems
Summary
5.E.1 Introduction
5.E.2 Regulatory requirements for the operation of a water system
5.E.3 Documents required for the operation of a water system
5.E.4 Handling faults
5.E.5 Rouging
5.E.5.1 What is rouging?
5.E.5.2 How does rouging impact the water quality?
5.E.5.3 How can rouging be addressed?
5.E.5.4 How can rouging be detected?
5.E.5.5 How can rouging be removed?
5.E.6 Biofilm
5.E.6.1 What is biofilm?
5.E.6.2 How does biofilm form?
5.E.6.3 How can biofilm be detected?
5.E.6.4 How can the formation of biofilm be prevented?
5.E.7 Process for reducing the microbial count
5.E.7.1 Sanitisation
5.E.7.2 Sterilisation process
5.E.7.3 Disinfection
5.E.8 Maintenance
5.E.9 Calibration
5.E.10 Change control
5.E.10.1 Critical and non-critical changes
5.E.11 Requalification
5.E.12 Decommissioning
5.F Pure steam systems
Summary
5.F.1 Basic physical principles
5.F.2 Quality requirements for pure steam
5.F.2.1 DIN EN 285
5.F.2.2 DIN 58950 Part 7
5.F.3 Pure steam generation
5.F.3.1 Degassing
5.F.3.2 Natural circulation method
5.F.3.3 Falling film method
5.F.3.4 Pure steam generator with an external heat exchanger
5.F.3.5 Separation systems
5.F.3.6 Quality-related measuring points (system parameters)
5.F.4 Pure steam distribution systems
5.F.4.1 Planning and design
5.F.4.2 Condensate drainage
5.F.4.3 Insulation
5.F.4.4 Pressure-reducing valves
5.F.4.5 Safety valves
5.F.4.6 Pipe connections
5.F.4.7 Sampling cooler
5.F.5 Qualification of a pure steam distribution system
5.F.5.1 Installation qualification
5.F.5.2 Operational qualification
5.G Monitoring Pharmaceutical Water
Summary:
5.G.1 How is the quality of pharmaceutical water monitored?
5.G.2 Physical monitoring of pharmaceutical water
5.G.2.1 Scope of monitoring
5.G.2.2 Failure of measuring devices
5.G.2.3 Warning and action limits
5.G.3 Microbiological monitoring of pharmaceutical water
5.G.3.1 Legal requirements
5.G.3.2 Monitoring plan
5.G.3.3 Sampling for the microbiological testing of water
5.G.3.4 Storage of samples between sampling and testing
5.G.3.5 Determining the total microbial count
5.G.3.6 Testing for specific types of microorganisms
5.G.3.7 Testing for coliform bacteria
5.G.3.8 Testing for endotoxins
5.H References
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