
- Pharmaceutical Technology-05-15-2018
- Volume 2018 eBook
- Issue 1
Lies That Environmental Monitoring Systems Tell
Environmental monitoring, which operates below the limit of detection, is little more than a rote exercise that provides limited real value. So why does it figure so prominently in current regulatory requirements for aseptic manufacturing?
In this extended op-ed, aseptic processing consultants James Agalloco, Russell Madsen, and James Akers discuss the current regulatory emphasis on environmental monitoring requirements. Based on the mistaken belief that monitoring is an exact measurement of reality, many current requirements emphasize monitoring when the real focus should be on minimizing operator contact with the process, they write.
Article Details
Pharmaceutical Technology
eBook: Biologics and Sterile Drug Manufacturing 2018
Vol. 42
May 2018
Pages: 4–7
Citation
When referring to this article, please cite it as J. Agalloco, R. Madsen, and J. Akers," Lies That Environmental Monitoring Systems Tell," Pharmaceutical Technology Biologics and Sterile Drug Manufacturing 2018 eBook (May 2018).
Articles in this issue
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Characterizing a Bioprocess with Advanced Data Analyticsabout 8 years ago
Can Standards Help Pharma Modernize Lyophilization?about 8 years ago
Residual Moisture Testing Methods for Lyophilized Drug Productsabout 8 years ago
Albumin Attachment Can Make Better Biobettersabout 8 years ago
Understanding Validation and Technical Transferabout 8 years ago
New Technologies Streamline Fill/Finish Manufacturing



