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| About the Author | |
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| Preface | |
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| Acknowledgements | |
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| Introduction | |
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| What is a Cleanroom? | |
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| The Need for Cleanrooms | |
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| Types of Cleanrooms | |
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| What is Cleanroom Technology? | |
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| The History of Cleanrooms | |
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| The Earliest Years | |
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| Ventilated Operating Rooms | |
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| Early Industrial Cleanrooms | |
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| Unidirectional Airflow Cleanrooms | |
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| Cleanroom Classification Standards | |
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| The History of Standards | |
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| The Basis of Cleanroom Standards | |
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| Federal Standard 209 | |
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| ISO Standard 14644-1:1999 | |
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| Pharmaceutical Cleanroom Classification | |
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| Classification of Cleanrooms with Airborne Chemical Contamination | |
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| Classification of Cleanrooms with Surface Contamination | |
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| Information Sources | |
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| The International Confederation of Contamination Control Societies (ICCCS) | |
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| The ICEB | |
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| International Cleanroom Standards | |
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| Cleanroom Books | |
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| Recommended Practices and Guides of the Institute of Environmental Sciences and Technology (IEST) | |
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| Cleanroom Journals and Magazines | |
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| Sources of Pharmaceutical Cleanroom Documents | |
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| Training Videos/DVDs | |
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| Non-unidirectional Airflow and Ancillary Cleanrooms | |
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| Non-unidirectional Airflow Cleanrooms | |
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| Ancillary Cleanrooms | |
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| Unidirectional Airflow Cleanrooms | |
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| Types of Unidirectional Cleanrooms | |
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| Vertical Unidirectional Airflow Cleanrooms | |
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| Horizontal Unidirectional Airflow Rooms | |
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| The Application of Unidirectional Airflow | |
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| Separative Clean Air Devices and Containment Zones | |
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| Unidirectional Airflow Devices | |
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| Mini-environments, Isolators and RABS | |
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| Containment Zones | |
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| Construction and Clean-build | |
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| Constructional Materials and Methods | |
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| Outgassing and Electrostatic Properties | |
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| Clean-build | |
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| High Efficiency Air Filtration | |
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| Air Filters Used in Cleanrooms | |
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| The Construction of High Efficiency Filters | |
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| Particle Removal Mechanisms | |
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| Testing of High Efficiency Filters | |
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| Scan Testing of High Efficiency Filters | |
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| Filter Housings for High Efficiency Filters | |
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| Removal of Airborne Chemical Contamination | |
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| Cleanroom Testing and Monitoring | |
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| Principles of Cleanroom Testing | |
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| Cleanroom Tests | |
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| Testing in Relation to Room Type and Occupation State | |
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| Re-testing to Demonstrate Compliance | |
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| Monitoring of Cleanrooms | |
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| Measurement of Air Quantities and Pressure Differences | |
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| Air Quantities | |
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| Differential Pressure Tests | |
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| Air Movement Control: Containment, Visualization and Recovery | |
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| Cleanroom Containment Leak Testing | |
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| Air Movement Control within a Cleanroom | |
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| Recovery Test Methods | |
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| Recovery Rate Requirement in the EU GGMP | |
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| Filter Installation Leak Testing | |
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| The Use of Aerosol Test Challenges | |
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| Artificial Aerosol Test Challenges | |
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| Apparatus for Measuring Aerosol Penetration | |
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| Methods of Testing Filters and Filter Housings | |
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| Repair of Leaks | |
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| Airborne Particle Counts | |
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| Airborne Particle Counters | |
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| Continuous Monitoring Apparatus for Airborne Particles | |
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| Particle Counting in Different Occupancy States | |
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| Measurement of Particle Concentrations | |
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| Worked Example of ISO 14644-1 Test Method | |
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| Microbial Sampling | |
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| Microbial Sampling of the Air | |
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| Microbial Deposition onto Surfaces | |
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| Microbial Surface Sampling | |
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| Personnel Sampling | |
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| Operating a Cleanroom: Managing the Risk from Contamination | |
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| Step 1: Identification of Sources and Routes of Contamination | |
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| Step 2: Risk Assessment and the Control of Sources of Contamination | |
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| Step 3: Establish an Effective Monitoring Programme | |
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| Step 4: Verification and Reappraisal of the System | |
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| Step 5: Documentation | |
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| Step 6: Staff Training | |
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| Cleanroom Disciplines | |
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| People Allowed into Cleanrooms | |
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| Personal Items Not Allowed into the Cleanroom | |
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| Disciplines within the Cleanroom | |
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| Maintenance and Service Personnel | |
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| Entry and Exit of Personnel | |
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| Prior to Arriving at the Cleanroom | |
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| Changing into Cleanroom Garments | |
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| Exit Changing Procedures | |
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| Materials, Equipment and Machinery | |
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| Choice of Materials for use in a Cleanroom | |
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| Items Supplied from Outside Manufacturing Sources | |
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| Wrapping and Transportation of Materials | |
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| Transfer of Items and Small Pieces of Equipment through a Materials Transfer Airlock | |
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| Entry of Heavy Machinery and Bulky Items | |
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| Transfer of Materials through Hatches and Sterilisers | |
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| Cleanroom Clothing | |
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| Sources and Routes of Inert Airborne Particle Dispersion | |
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| Sources and Routes of Airborne Microbial Dispersion | |
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| Types of Cleanroom Clothing | |
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| Processing of Cleanroom Garments and Change Frequency | |
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| The Effect of Laundering and Wear | |
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| Testing of Cleanroom Clothing | |
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| Static Dissipative Properties of Clothing | |
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| Cleanroom Masks and Gloves | |
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| Cleanroom Masks | |
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| Cleanroom Gloves | |
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| Cleaning a Cleanroom | |
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| Why a Cleanroom must be Cleaned | |
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| Cleaning Methods and the Physics of Cleaning Surfaces | |
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| Implements Used to Clean Cleanrooms | |
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| Liquids Used in Cleaning Cleanrooms | |
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| How Should a Cleanroom be Cleaned? | |
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| Cleaning Programme | |
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| Test Methods | |
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| Index | |