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

Abstract

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

References

1. Association of technical standards. NBR ISO 14644-1: Clean rooms and associated controlled environments: Part 1: Classification of air cleanliness by particle concentration, Rio de Janeiro. 2^nd, (2019).
2. American Pharmacopeia, 1116 Microbiological control and monitoring of aseptic processing environments.
3. National Health Surveillance Agency. Normative Instruction No. 35, of August 21, 2019, Provides for Good Manufacturing Practices complementary to sterile drugs. ANVISA (2019).
4. National Health Surveillance Agency. Pharmacopoeia Brasileira, 6th ed., Brasília, chapter 8: General information 1 (2019).
5. National Health Surveillance Agency. Brazilian Pharmacopoeia, 6^th ed., Brasília, (2019): 685.
6. National Health Surveillance Agency. Brazilian Pharmacopoeia, 6^th ed., Brasília, (2019): 703.
7. Workshop aseptic processing, 2019, São Paulo. Anais. São Paulo: PDA (2019).

Citation

Citation: Moniky Rufino dos Santos Andreoli. “Importance of Environmental Monitoring in Clean Room". Acta Scientific Microbiology 5.2 (2022): 43-47.

Copyright

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.