All Environmental Monitoring articles – Page 3
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ArticleUnder the microscope: Using recombinant reagents for BET
Veronika Wills, Associate Director, Global Technical Services at Associates of Cape Cod, Inc (ACC), discusses in-depth, motivations and strategies surrounding the use of recombinant reagents for bacterial endotoxin testing.
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Whitepaper
Application note: Isokinetic microbial air sampling on MAS-100 instruments
Microbial air sampling in controlled environments should be performed isokinetically. The following text explains the isokinetic sampling process using MAS-100 instruments with a flow rate of 100 L/min and compares it with sampling at a lower flow rate of 25 L/min.
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ArticleEuropean Pharmaceutical Review Issue 2 2024
European Pharmaceutical Review Issue 2 includes articles on cell and gene therapy, from supply chain and manufacturing to microbial testing.
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Webinar
Testing of rapid microbiological methods (RMMs) - demonstrating equivalence to existing methods in alignment with USP <1223>
Watch this on demand webinar to hear about the latest RMM technology and how it aligns with USP testing criteria. This webinar will cover testing strategy, and data will be presented to effectively demonstrate suitability of the Soleil for its intended use and correlation to plate counts.
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NewsMicrobe-carrying particle recovery efficacy with manual surface sampling
Three different contact plate methods were tested to determine a convenient manual surface sampling technique for microbial contamination recovery, the paper explained.
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NewsStudy monitors particles and falling bacteria in biosafety cabinets
The type of clothing worn in aseptic manufacturing areas may impact the number of particle and airborne bacteria detected in biosafety cabinets.
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NewsWidening adoption of animal-free reagents for endotoxin testing
If the proposed USP Chapter on using non-animal derived reagents is approved, it will be published for early adoption in November 2024, USP states.
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NewsEP monographs allow rFC for water testing
As of 1 April, two European Pharmacopoeia monographs allow the use of rFC to test for bacterial endotoxins in pharmaceutical waters.
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ArticleEndotoxin testing: the international regulatory landscape
In this extract from EPR’s Pharma Horizon’s report, Evelyn Der, Lindsey Silva and Carmen Marín Delgado de Robles from Roche Group discuss the regulatory guidelines for bacterial endotoxin testing and the move towards adoption of recombinant methods.
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NewsPharmaceutical environmental monitoring market to value $38.1b by 2030
Technological solutions such as real-time monitoring could help expand the pharmaceutical environmental monitoring market up to the next decade, research says.
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Webinar
Comprehensive evaluation of Growth Direct® Rapid Sterility for microorganism detection
Discover the extensive panel testing done to evaluate the new, innovative sterility testing platform, Growth Direct® Rapid Sterility.
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ReportPharma Horizons: Environmental Monitoring
This report is dedicated to exploring some of the latest advances in pharmaceutical environmental monitoring, covering topics from contamination control and cleanroom validation through to emerging technologies for bacterial endotoxin testing.
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Whitepaper
Solution brief: Environmental monitoring software
Monitoring microbial contamination levels at various stages requires focused, independent software with extended controls over microbial management. Digital monitoring of contaminants and their sources helps understand microbial behavior and trends. Thus, a reinforced, data- driven environmental monitoring mechanism is the key to maintaining controlled lab spaces for microbial trend analysis. ...
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NewsPreventing fungal contamination in pharmaceuticals
While fungal contamination detection in pharmaceutical manufacturing remains a challenge, preventive practices and policies must be followed, research states.
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Webinar
Are outdated microbial identification methods risking your product safety and operational efficiency?
Watch this webinar to unravel the complexities of microbial identification technologies and their pivotal role in fortifying contamination control strategies within the pharmaceutical industry.
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ReportPharma Horizons: Artificial Intelligence
EPR’s inaugural Pharma Horizons report explores the latest advances in artificial intelligence (AI) and machine learning (ML) for drug development, pharmaceutical manufacturing and quality control.
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Webinar
Applying ISO/TR 14644-21 - Airborne particle sampling techniques
Watch this webinar as GMP expert Mark Hallworth discusses the difference between cleanroom classification and monitoring of the new ISO 14644 Technical Report 21 focuses in section 4.0 and 5.2.
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VideoVideo: Unveiling the science behind NGS
Virtual seminar presented by Christine Farrance, PhD, Senior Global Scientific Affairs Liaison of Microbial Solutions at Charles River designed to improve your understanding of how to leverage NGS to analyze the entire genome and mixed samples in a single, efficient test to identify, classify, and understand microbes in mixed and ...
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ArticleYear in review: EPR’s top stories of 2023
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
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Whitepaper
Whitepaper: The value and benefits of rapid mold detection in the pharmaceutical industry
Address the importance of accurate microbial identifications and proper contamination control for effective mold remediation.