Abstract

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Title Environmental Monitoring and Risk Assessment of Cleanrooms within Pharmaceutical Industry
Authors Azam Mehdi, Muhammad Danish Mehmood*, Muhammad Usman Ghani, Muhammad Ismail, Faisal Ameen, Saud-ul-Hassan
Description

Environmental monitoring is a scrutinizing program for microbial and particulate contamination of clean rooms and associated clean zones for aseptic processing. The current study was therefore, designed to evaluate the quality of clean rooms environment of local vaccine manufacturing unit in compliance with the international cleanroom standards proposed by the World Health Organization (WHO) for the production of quality biological products. The classified areas were divided into 60 gridlines where 30 sampling sites were randomly identified in which 20 critical and 10 non-critical sites were allocated and 700 liters/m3 air was aspirated through air sampler. Furthermore, particles size of 0.5 um and 5.0 um were also detected for 1 minute from all critical and non-critical sites. It was revealed that viable count obtained from sampling sites designated as class A of Production Section I and II was less than ≤ 1 CFU/m3 . Whereas, the number of non-viable particles having size of ≤ 0.5 μm in class A at rest were ≤ 3,520 CFU/m3 as compare to 20/m3 of particle size ≥ 0.5 from each sampling sites in both the sections. Moreover, Finger DAB testing confirmed the hygienic status of personnel and proper use of antiseptics and sterile garments (˂1 CFU/gloves). Manometer readings in three airlocks in production section were recorded as 0.05, 0.10 and 0.15 inch of water gauge respectively. Consequently, it is concluded that all sections of vaccine manufacturing unit are comply with WHO cleanroom standards. In each sampling site of all clean zones shows viable and non-viable counts within the limits set by local authorities and international cleanroom standards.

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