as of 2019 - 03 - 18
10 Hygiene
10.A Industrial Hygiene
Summary
10.A.1 Definitions
10.A.2 Organisational principles
10.A.2.1 Definition of personnel and material flow
10.A.2.2 Definition of processes
10.A.2.3 Premises and installed facilities
10.A.3 Responsibilities
10.A.4 Sources of contamination
10.A.5 Monitoring
10.B Personnel Hygiene
Summary
10.B.1 Clothing
10.B.1.1 Clothing requirements
10.B.1.2 Technical requirements
10.B.1.3 Clothing elements
10.B.1.4 The selection of clothing
10.B.1.5 Laundering clothing (decontamination)
10.B.2 Hygienic behaviour
10.B.2.1 Personal hygiene
10.B.2.2 General personnel hygiene requirements
10.B.2.3 Clean room requirements
10.B.2.4 Hand hygiene
10.B.3 Behaviour during processing
10.B.4 Health status
10.B.4.1 Reasons for health surveillance
10.B.4.2 Responsibilities
10.B.4.3 Health surveillance system
10.B.5 Hygiene training
10.B.5.1 Content of hygiene training courses
10.B.5.2 Criteria for a successful implementation
10.B.5.3 Success control
10.B.5.4 Application of training course content
10.B.5.5 Qualification of clean room personnel
10.B.6 Sample personnel hygiene SOPs
10.B.6.1 Sample gowning instruction SOP
10.B.6.2 Sample hand disinfection SOP
10.B.6.3 Sample health surveillance SOP
10.B.6.4 Sample gowning procedure qualification SOP
10.C Production hygiene
Summary
10.C.1 Sources of contamination
10.C.1.1 Premises and facilities
10.C.1.2 Starting materials
10.C.1.3 Packaging materials
10.C.1.4 Cleaning and disinfecting agents
10.C.1.5 Aids
10.C.1.6 Gases
10.C.1.7 Ambient air
10.C.1.8 Processes
10.C.2 Cleaning
10.C.2.1 Cleaning agents
10.C.2.2 Cleaning process and aids
10.C.2.3 Procedure for cleaning production rooms
10.C.3 Disinfection
10.C.3.1 Disinfecting agents
10.C.3.2 Disinfection process and aids
10.C.3.3 Deviations
10.C.3.4 Training
10.C.4 Sample cleaning and disinfection SOP
10.D Hygiene plan
Summary
10.D.1 Organisation of room cleaning
10.D.1.1 Hygiene zones
10.D.1.2 General room cleaning
10.D.1.3 Cleaning and disinfecting agents
10.D.1.4 Cleaning process and aids
10.D.2 Documentation
10.D.3 Periodic evaluation
10.E Microbiological monitoring
Summary
10.E.1 Introduction
10.E.2 Sources of contamination
10.E.2.1 Air
10.E.2.2 Surfaces
10.E.2.3 Personnel
10.E.3 Levels (limit values)
10.E.3.1 Alert and action levels
10.E.3.2 Microbiological quality of air
10.E.3.3 Microbiological quality of surfaces
10.E.3.4 Microbiological requirements for personnel
10.E.3.5 Rates of deviation in accordance with the USP
10.E.4 Materials and methods
10.E.4.1 Culture media
10.E.4.2 Incubation
10.E.4.3 Method validation
10.E.5 Sampling
10.E.5.1 Testing frequencies
10.E.5.2 Sampling points
10.E.6 Growth controls
10.E.6.1 Evaluation
10.E.6.2 What is the significance of growth controls?
10.E.7 In-house isolates
10.E.7.1 Creation of isolate libraries
10.E.8 Microbiological testing of air
10.E.8.1 Qualitative methods
10.E.8.2 Quantitative methods
10.E.9 Microbiological monitoring of surfaces and personnel
10.E.9.1 Swab method
10.E.9.2 Contact method with solid culture media
10.E.9.3 Hand-washing method
10.E.10 Actions when levels are exceeded
10.E.10.1 Investigation plan
10.E.10.2 Investigation report
10.E.11 Identification of microorganisms
10.F References
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