Moniky Rufino dos Santos Andreoli*
Biologist - Specialist in Clinical Analysis, Brazil
*Corresponding Author: Moniky Rufino dos Santos Andreoli, Biologist - Specialist in Clinical Analysis, Brazil.
Received: December 31, 2021; Published: January 21, 2022
The aseptic area or clean room in pharmaceutical industries is where sterile products are produced. Where the final sterile product is not subjected to terminal sterilization. For this sterile product to meet the requirements of sterility and absence of pyrogenics, the environment must be controlled, meet cleaning standards and undergo qualification. For this, Normative Instruction Number 35 of August 21, 2019 and ISO 14644-1 must be followed. In this case, for a safe production with regard to contamination by microorganisms, it is necessary to carry out environmental monitoring. These areas are called Clean Rooms and are classified into classes 5, 6, 7 and 8. Each degree has a need for environmental monitoring in addition to having control of air flow, pressure, temperature, humidity, noise, vibration and lighting.
Keywords:Clean Room; Steriles; Microorganisms; Environmental Monitoring
Citation: Moniky Rufino dos Santos Andreoli. “Importance of Environmental Monitoring in Clean Room". Acta Scientific Microbiology 5.2 (2022): 43-47.
Copyright: © 2022 Moniky Rufino dos Santos Andreoli. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.