Environmental Monitoring for Cleanrooms and Controlled Environments provides comprehensive information about environmental monitoring, including monitoring of viable and non-viable air, surfaces, water, alert and action levels, trending, procedures for responding to excursions, certification/requalification, and the application of new ISO standards.

Because the interpretation of results is vital in controlling contamination, several chapters discuss the presentation of data, trending, and investigations, and how they are valuable in reducing risk to the product, process, and patient.

Providing must-have information on the entire subject of environmental monitoring, Environmental Monitoring for Cleanrooms and Controlled Environments:

• presents background information on the performance of aerosols in cleanrooms or controlled environments
• provides sections on particle, viable air, and surface monitoring, which include considerations for optimal equipment selection, operation, maintenance, data generation and analysis, and management
• discusses aseptic processing simulations in clear and concise terms to ensure acceptability of the process

Contents

1. The Behavior of Particles in Cleanrooms
2. The Application of the New ISO Cleanroom Standards
3. Cleanroom Certification and Particulate Testing
4. Air Viable Monitoring
5. Microbial Surface Sampling
6. Endotoxin
7. Water Monitoring
8. Process Simulations (Media Fills)
9. Sterility Testing

Index

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