Powered by OpenAIRE graph
Found an issue? Give us feedback
image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/ ZENODOarrow_drop_down
image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
ZENODO
Other literature type . 2024
License: CC BY
Data sources: ZENODO
ZENODO
Other literature type . 2024
License: CC BY
Data sources: Datacite
ZENODO
Other literature type . 2024
License: CC BY
Data sources: Datacite
versions View all 2 versions
addClaim

Research Paper on API Pharma Clean Rooms

Authors: LBR Chakravarthy, Sidharth Singh;

Research Paper on API Pharma Clean Rooms

Abstract

The pharmaceutical industry necessitates strict regulation of manufacturing environments for Active Pharmaceutical Ingredients (APIs) to guarantee product stability and adherence to regulatory standards. This thesis examines the optimization and design of API pharma rooms with a focus on improving product stability and ensuring compliance with regulatory standards. The study begins by introducing the essential role of controlled environments in API production. It then provides a thorough examination of global regulatory standards and their implications for pharmaceutical manufacturing facilities. Key environmental parameters impacting API stability, such as temperature, humidity, air quality, and light exposure, are thoroughly investigated. Advanced HVAC systems, air filtration, and real-time monitoring technologies essential for maintaining optimal conditions are examined. The analysis extends to architectural and structural factors, including cleanroom classifications, building materials, and surface finishes, to ensure contamination control and facilitate maintenance. Case studies demonstrate the positive impact of precise environmental control on product stability. The study also explores risk assessment approaches, contingency planning, and the integration of automation technologies to enhance reliability and compliance. This thesis presents effective strategies and insights for optimizing API pharma rooms, aiming to guide future research and development in this crucial area, ultimately contributing to higher product stability, regulatory adherence, and operational excellence in the pharmaceutical sector.

  • BIP!
    Impact byBIP!
    selected citations
    These citations are derived from selected sources.
    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    0
    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Average
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Average
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Average
Powered by OpenAIRE graph
Found an issue? Give us feedback
selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average