Tabla de Contenidos: “…Andersen and Kathy R. Berenson; 12. Ideal standards in close relationships / Garth J. O. Fletcher and Jeffry A. …”

Tabla de Contenidos: “…2.3.5 Product Quality Review -- 3 Organization and Personnel -- 3.1 Responsibilities of Various Departments -- 3.1.1 Production Department -- 3.1.2 QC Department -- 3.1.3 Shared Responsibilities Between the QC Head and Production Department Head -- 3.1.4 Personal Responsibilities of Employees in Manufacturing Premises -- 4 Building and Facilities -- 4.1 Storage Area -- 4.2 QC Area -- 4.3 Production Area -- 4.4 Ancillary Area -- 4.5 Lighting -- 5 Heating, Ventilation, and Air Conditioning (HVAC) System -- 5.1 Importance of HVAC -- 5.2 HVAC System -- 5.3 Cleanroom Classification -- 5.4 Cleanroom Separation/Segregation -- 5.5 Personnel Training -- 5.6 Sanitation and Personal Hygiene -- 5.7 Gowning/Change Room Control and Configuration -- 6 Validation of HVAC System -- 6.1 Airflow Pattern -- 6.2 Airflow Velocity and Changes per Hour -- 6.3 Filter Leak Test -- 6.4 Particle Count Test -- 6.5 Viable Monitoring -- 6.5.1 Active Air Sampling -- 6.5.2 Passive Air Sampling -- 6.5.3 Surface Monitoring -- Contact plate method -- Swabbing method -- 6.6 Filter Integrity Test (DOP/PAO Test) -- 6.7 Pressure Difference -- 6.8 Recovery Test -- 6.9 Temperature and Humidity Uniformity Test -- 6.10 Fresh Air Determination -- 6.11 Acceptance Criteria for HVAC System -- 7 Summary -- References -- 4 The Role of Standards in Cleaning and Contamination Control -- 1 Scope -- 2 Why There Are Standards? -- 2.1 Ideal Standards-and Real Standards -- 2.2 Chronic Emergency Standards -- 2.3 Perfection Versus Reality -- 2.4 Language -- 2.5 Agendas -- 2.6 Political Influences -- 2.6.1 Regulatory Organizations -- 2.6.2 Intentionally Ambiguous Wording -- 2.7 Process -- 2.8 Emergencies -- 3 Examples of Groups, Industry Standards, and Specifications -- 3.1 American Society for Testing and Materials -- 3.1.1 ASTM Standards -- 3.1.2 Specific Standards -- 3.1.3 How Does ASTM Develop Standards?…”