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Page 1 of 37 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 2 of 37 Table of Contents 1. INTRODUCTION ..3 2. RISK ASSESSMENT APPLIED TO Clean room GRADE RECOMMENDATIONS FOR VACCINE PRODUCTION ACTIVITIES ..4 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 Clean room classification schemes .. 16 Clean room classification based on airborne particulates .. 17 WHO requirements.
Page 1 of 37 Environmental Monitoring of Clean Rooms in Vaccine Manufacturing Facilities Points to consider for manufacturers of human vaccines
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