Intro
Title
Copyright
Contents
Chapter 1 Introduction
Chapter 2 Personnel
2.1 Management Responsibilities
2.2 Typical Roles
2.3 Personnel Responsibilities
2.4 Training
2.4.1 Training Evaluation
2.4.2 Training Records
2.5 Personnel Hygiene
2.6 Personnel Health
2.7 Visitors and Untrained Personnel
References
Chapter 3 Premises
3.1 Layout
3.2 Buildings
3.3 Health and Safety
3.3.1 Hazardous Materials
3.4 Finishes
3.4.1 Building Within a Building
3.4.2 General
3.4.3 Walls
3.4.4 Windows
3.4.5 Doors
3.4.6 Floors
3.4.7 Interface Between Floors and Walls
3.4.8 Mezzanine Platforms
3.4.9 Ceilings
3.4.10 Lighting
3.4.11 Drains
3.5 Heating, Cooling and Ventilation
3.5.1 Ventilation
3.5.2 Temperature Control
3.5.3 Humidity Control
3.5.4 Pressure Control
3.5.5 Heating and Cooling Systems
3.5.6 Local Exhaust Ventilation
3.6 Utilities
3.6.1 Electrical Supply
3.6.2 Water Systems
3.6.3 Compressed Air
3.6.4 Vacuum
3.6.5 Labelling Pipework
3.7 Cleaning
3.8 Pest Control
3.9 Fire Alarm Systems
3.10 Maintenance
3.11 Security
References
Chapter 4 Equipment
4.1 General
4.2 Microbiological Control Strategy
4.3 Materials of Construction
4.3.1 Stainless Steel
4.3.2 Steel
4.3.3 Plastics and Polymers
4.3.4 Polymer Gaskets and Seals
4.3.5 Polymer Pipework
4.3.6 Hoses
4.3.7 Glass
4.4 Cleaning and Sanitisation of Equipment
4.4.1 Equipment Drain-ability
4.4.2 Equipment Clean-ability
4.4.3 Process Pipework Connections
4.4.4 Valves
4.4.5 Product Recovery
4.4.6 Manual Cleaning
4.5 Clean in Place
4.6 Off-line Cleaning
4.7 Cleaning Validation
4.8 Eliminating Water from Process Equipment
4.9 Disposable Technology
4.10 Product Development Laboratory
4.10.1 Product Development Laboratory Design
4.10.2 Product Development Laboratory Basic Equipment
4.10.3 Overhead Stirrers
4.10.4 Hotplates and Magnetic Stirrers
4.10.5 High Shear Mixers (Dispersers)
4.10.6 pH Meter
4.10.7 Viscometer
4.10.8 Digital Thermometer
4.10.9 Pycnometer
4.10.10 Water Bath
4.10.11 Stability Testing Storage Chambers
4.10.12 Light Box or Lightbooth
4.10.13 Purified Water System
4.10.14 Parts Washer
4.11 Weighing Equipment
4.12 Instruments and Calibration
4.13 Mixing Systems
4.13.1 Mechanical Seals
4.13.2 Mixer Manways
4.13.3 Raw Material Addition Ports
4.13.4 High Shear Mixers
4.13.5 Mixers for Liquids, Creams and Semi-solids
4.13.6 Powder Mixers
4.13.7 Mixer Size
4.14 Storage Tanks
4.15 Transfer Pumps
4.15.1 Diaphragm Pumps
4.15.2 Rotary Lobe Pumps
4.15.3 Centrifugal Pump
4.15.4 Sine Pump
4.15.5 Peristaltic Pumps
4.15.6 Powder Pumps
4.16 Filtration of Batches
4.17 Filling
4.17.1 Manual Filling
4.17.2 Manual Filling Equipment