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5 Pharmaceutical Water
5.A Water types
5.A.1 Potable water

5.A.2 Purified water

5.A.3 Water for injection

5.A.4 Highly purified water

5.B Generation of pharmaceutical water

5.B.1 Purified water (PW)
5.B.1.1 Airbreak

5.B.1.2 Softener

5.B.1.3 Removal of chlorine

5.B.1.4 Reverse osmosis

5.B.1.5 Electrodeionisation (EDI, CDI)

5.B.1.6 Ultra filtration

5.B.1.7 Ion exchanger

5.B.1.8 Purification plants

5.B.2 Water for injection (WFI)

5.B.2.1 Distillation technology

5.B.3 Purification of pharmaceutical water treatment

systems

5.C Distribution and storage of pharmaceutical

water
5.C.1 Loop
5.C.1.1 Flow rate and turbulent flow

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5.C.1.2 Pipes

5.C.1.3 Requirements of welds

5.C.1.4 Dead end piping

5.C.1.5 Use of plastics (PVDF)

5.C.2 Fixtures
5.C.2.1 Valves

5.C.2.2 Sensors

5.C.2.3 Sterile filter

5.C.2.4 Sampling points

5.C.3 Measuring technique

5.C.3.1 Level measurement

5.C.3.2 Flow measurement

5.C.3.3 Conductivity measurement

5.C.3.4 Pressure measurement

5.C.3.5 Temperature measurement

5.C.3.6 Ozone measurement (online)

5.C.3.7 TOC measurement (online)

5.C.4 Formation of biofilms

5.C.5 Rouging
5.C.5.1 What is rouging?

5.C.5.2 Impact on the water quality

5.C.5.3 Handling rouging

5.C.5.4 How can you detect rouging?

5.C.5.5 Measures against rouging

5.C.6 Buffering of ultra pure water

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5.C.7 Loop with subloops

5.C.7.1 Cleanability of the loop for purified water

5.C.7.2 Valve groupings

5.D Qualification of water supplies

5.D.1 Introduction

5.D.2 Risk analysis

5.D.3 Design qualification

5.D.3.1 User requirements

5.D.3.2 Technical specification

5.D.3.3 Test protocol

5.D.3.4 Test record

5.D.4 Installation qualification

5.D.4.1 Facility documentation

5.D.4.2 Test protocol

5.D.4.3 IQ test record

5.D.5 Operational qualification (OQ)

5.D.5.1 Test protocol (OQ)

5.D.5.2 OQ test record

5.D.6 Handover to the user

5.D.6.1 Handover report

5.D.7 Process validation/performance qualification (PQ)

5.D.7.1 Microbiological tests for pharmaceutical water

5.D.7.2 Determination of alert and action limits

5.D.7.3 Sampling

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5.D.8 Qualification report

5.E Operation of water supplies

5.E.1 Procedure to reduce microbial counts
5.E.1.1 Sanitisation

5.E.1.2 Sterilisation procedure

5.E.1.3 Disinfection

5.E.2 Maintenance of a water supply

5.E.2.1 Quality-relevant maintenance

5.E.2.2 Safety-relevant maintenance

5.E.2.3 Value-maintaining maintenance

5.E.3 Calibration of measuring systems

5.E.4 Change control

5.E.4.1 Major and minor changes

5.E.5 Requalification
5.E.5.1 After major changes

5.E.5.2 After defined interval

5.E.6 Decommissioning/uninstalling
5.E.6.1 Shutting down the water supply

5.E.6.2 Disassembly work on the facility

5.F Pure steam systems

5.F.1 Physical principles

5.F.2 Quality requirements for pure steam

5.F.2.1 DIN EN 285 (1997-2)

5.F.2.2 DIN 58950 part 7 (April 2003)

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5.F.3 Pure steam generation

5.F.3.1 Degassing

5.F.3.2 Natural circulation procedure

5.F.3.3 Downdraft procedure

5.F.3.4 Pure steam generator with external heat exchanger

5.F.3.5 Separation systems

5.F.3.6 Quality-relevant measuring points

5.F.4 Pure steam distribution system

5.F.4.1 Planning and layout

5.F.4.2 Condensate drain

5.F.4.3 Insulation

5.F.4.4 Pressure reducing valve

5.F.4.5 Safety valve

5.F.4.6 Pipe connections

5.F.4.7 Sampling cooler

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