1 Quality Management Systems
1 Quality Management Systems
2 Personnel
2 Personnel
3 Premises
3 Premises
4 Facilities and Equipment
4 Facilities and Equipment
4.A Facility Planning
4.A Facility Planning
4.B Materials
4.B Materials
4.C Hygienic design in solids handling
4.C Hygienic design in solids handling
4.D System controllers and process control systems
4.D System controllers and process control systems
4.E Technical documentation
4.E Technical documentation
4.F Calibration
4.F Calibration
4.G Maintenance
4.G Maintenance
4.H Cleaning of facilities
4.H Cleaning of facilities
4.H.1 Cleaning technology
4.H.1 Cleaning technology
4.H.2 Cleaning process
4.H.2 Cleaning process
4.H.3 CIP systems
4.H.3 CIP systems
4.H.4 GMP-compliant design of CIP systems
4.H.4 GMP-compliant design of CIP systems
4.H.5 Nozzle heads for tank cleaning
4.H.5 Nozzle heads for tank cleaning
4.H.6 Measurement technology
4.H.6 Measurement technology
Summary
Summary
4.I Containment (personnel protection) in solids handling
4.I Containment (personnel protection) in solids handling
4.J References
4.J References
5 Pharmaceutical Water
5 Pharmaceutical Water
6 Qualification
6 Qualification
7 Process Validation
7 Process Validation
8 Cleaning Validation
8 Cleaning Validation
9 Computer System Validation
9 Computer System Validation
10 Hygiene
10 Hygiene
11 Production
11 Production
12 Sterile Production
12 Sterile Production
13 Packaging
13 Packaging
14 Laboratory Controls
14 Laboratory Controls
15 Documentation
15 Documentation
16 Research and Development
16 Research and Development
17 Contractors and Suppliers
17 Contractors and Suppliers
18 Inspections
18 Inspections
19 Quality Risk Management
19 Quality Risk Management
20 Continual Improvement
20 Continual Improvement
21 Active Pharmaceutical Ingredients
21 Active Pharmaceutical Ingredients
22 Excipients
22 Excipients
23 Medical Devices
23 Medical Devices
24 Storage and Transportation
24 Storage and Transportation
as of 2019 - 01 - 24

4.H Cleaning of facilities

4.H Cleaning of facilities
Here you will find answers to the following questions:
●

What are automatic, semi-automatic and manual cleaning methods?
●

What are the advantages and disadvantages of the three methods?
●

How do I choose the correct method?
●

What requirements do the components of CIP systems (piping, seals, pumps, valves, nozzle heads) have to meet?
●

What parameters are recorded continuously and for qualification?
4.H Cleaning of facilities
Summary
4.H.1 Cleaning technology
4.H.2 Cleaning process
4.H.2.1 Automatic, semi-automatic and manual processes
4.H.2.2 Comparison of cleaning methods
4.H.2.3 Special technologies
4.H.2.4 Developing a cleaning process
4.H.3 CIP systems
4.H.3.1 Single pass WIP/CIP
4.H.3.2 Single use WIP/CIP
4.H.3.3 Solution recovery WIP/CIP
4.H.3.4 Selecting the appropriate technology
4.H.4 GMP-compliant design of CIP systems
4.H.4.1 Surface influences
4.H.4.2 Flow-optimised design
4.H.4.3 Tanks
4.H.4.4 Connecting elements and seals
4.H.4.5 Pumps
4.H.4.6 Valves
4.H.4.7 Heat exchangers
4.H.5 Nozzle heads for tank cleaning
4.H.6 Measurement technology
4.H.6.1 Requirements for measuring points
4.H.6.2 Measurement of the flow rate
4.H.6.3 Pressure measurement
4.H.6.4 Temperature measurement
4.H.6.5 Conductivity measurement
4.H.6.6 Measurement of the filling level
4.H.6.7 Flow measurement

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