Environmental Monitoring of Clean Rooms in （洁净室环境监测的）.pdf

Environmental Monitoring of Clean Rooms in Vaccine Manufacturing Facilities Points to consider for manufacturers of human vaccines November 2012 Vaccine Quality and Regulations (VQR), Quality, Safety, and Standards (QSS) Essential Medicines and Health Products (EMP) Department World Health Organization (WHO), Geneva, Switzerland Page 1 of 37 Table of Contents 1. INTRODUCTION3 2. RISK ASSESSMENT APPLIED TO CLEAN ROOM GRADE RECOMMENDATIONS FOR VACCINE PRODUCTION ACTIVITIES 4 2.1. Recommended clean room grades for operations during the manufacture of prequalified vaccines 6 3. CLASSIFICATION AND ENVIRONMENTAL MONITORING (EM) OF CLEAN ROOMS AND LAMINAR FLOW WORKSTATIONS 16 3.1. Clean room classification schemes 16 3.2. Clean room classification based on airborne particulates 17 3.2.1. WHO requirements 17 3.2.2. Use of other standards for prequalification purposes 17 3.2.3 Particulate sampling methods 18 3.2.4. Clean room classification 18 3.2.5. Routine monitoring for particulates 19 3.2.6. Sampling frequencies for routine monitoring of particulates 21 3.2.7. Particulate routine monitoring data analysis 22 3.3. Environmental monitoring of microorganisms 23 3.3.1. WHO requirements 23 3.3.2. Monitoring of microorganisms 23 3.3.4. Growth promotion testing 24 3.3.5. Volumetric air sampling for microorganisms 25 3.3.6. Surface sampling for microorganisms 27 3.3.7. Microbiological classification of clean rooms 28