Transcription of Clean Rooms – Environmental Monitoring
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Clean Rooms – Environmental Monitoring
Pharmaceutical Facility Design Spring 20091 PhEn-602 Notes # 4 J. ManfrediPharmaceutical Facility Design Spring 20092 Clean Rooms and Controlled EnvironmentsBasic definitions Clean room :A room in which the concentration of airborne particles is controlled and contains one or more Clean zones Clean Zone:A defined space in which the concentration of airborne particles is controlled to meet a specified airborne particulate class. Pharmaceutical Facility Design Spring 20093 Clean Rooms and Controlled Environments Federal Standard 209E (FS-209E) provides Clean room Classes Rooms classified based on number of particles > micron per cubic foot Class descriptions still in use today. FS 209E is concerned about the following particle sizes, in , , , , Facility Design Spring 20094 Clean Rooms and Controlled Environments Types of Contaminants Viable Particulates Non-Viable ParticulatesPharmaceutical Facility Design Spring 20095 Controlled Environments -Types of Contaminants Non-viable Particulates Metal specks, fiber from clothing Obtained from: Equipment, people, tools Viable (micro-organisms) Bacteria Yeast, molds Obtained from: People, outside air, water, equipment, tools, excipients, active ingredientsPharmaceutical Facility Design Spring 20096 Clean Rooms and Controlled EnvironmentsSources of particulate generation Internal: Personnel Normally the highest source of contam
Clean Rooms and Controlled Environments Basic definitions Clean Room: A room in which the concentration of airborne particles is controlled and contains one or more clean
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