Acta Scientific Microbiology (ISSN: 2581-3226)

Review Article Volume 5 Issue 2

Importance of Environmental Monitoring in Clean Room

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. 2nd, (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, 6th ed., Brasília, (2019): 685.
  6. National Health Surveillance Agency. Brazilian Pharmacopoeia, 6th 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.




Metrics

Acceptance rate30%
Acceptance to publication20-30 days

Indexed In






News and Events


  • Certification for Review
    Acta Scientific certifies the Editors/reviewers for their review done towards the assigned articles of the respective journals.
  • Submission Timeline for Upcoming Issue
    The last date for submission of articles for regular Issues is December 15, 2022.
  • Publication Certificate
    Authors will be issued a "Publication Certificate" as a mark of appreciation for publishing their work.
  • Best Article of the Issue
    The Editors will elect one Best Article after each issue release. The authors of this article will be provided with a certificate of “Best Article of the Issue”.
  • Welcoming Article Submission
    Acta Scientific delightfully welcomes active researchers for submission of articles towards the upcoming issue of respective journals.
  • Contact US