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Environmental Monitoring Articles & Analysis
28 articles found
The ongoing exploration of OTUs not only enriches our knowledge of microbial ecology but also has significant implications for public health, environmental monitoring, and biotechnology. ...
ApplicationsORD is commonly used to determine the absolute and relative configurations of compounds, monitor changes in chiral centers during chemical or biological processes (such as enzymatic reactions), and assess the purity and concentration of chiral drugs.3. ...
Overview Cleanrooms are essential in the pharmaceutical industry, providing controlled environments for the aseptic production of sterile products. Recently, big data analytics has emerged as a transformative tool, offering new ways to enhance cleanroom performance beyond traditional ...
Real-life examples brought to the fore the myriad of challenges faced during vaccine shipments: from unexpected delays to fluctuating environmental conditions, the journey of a vaccine from the manufacturer to the end recipient is filled with potential pitfalls. This is where the importance of data loggers comes into play. These devices, which monitor ...
Harnessing the power of cell biology, scientists across the globe are perpetually invested in the pursuit of understanding the complexities of cellular mechanisms and their adaptability. One such venture is the creation of Inducible Expression Stable Cell Line (IESCL) development. IESCL signifies a consolidated methodology designed to explore the potentialities of modulated gene expression. This ...
Metatranscriptomic sequencing provides direct access to culturable and non-culturable microbial transcriptome information by large-scale, high-throughput sequencing of transcripts from all microbial communities in specific environmental samples. Metatranscriptomic sequencing offers an opportunity to randomly sequence mRNAs as a unit for understanding the regulation of complex ...
Part of Particle Measuring Systems’ role in making the world make the world cleaner, healthier & more productive As part of the Spectris PLC family of businesses, we aim to deliver value to society by providing solutions that make the world cleaner, healthier, and more productive. As part of Spectris, Particle Measuring Systems (PMS) supports this purpose in a variety of ways. One of ...
Click here to learn how BioFlash, our portable environmental monitoring solution, can help ensure indoor environments are free of infectious virus particles or detect the presence of airborne COVID-19 to stop the spread. ...
For more information on CL:AIR GAC and soil guideline values, you can use the fantastic resource available on the environmental standards page of the esdat.net website to search and use environmental standards and guidelines. Environmental Standards are available for air, water and soil for the United States, Canada, Australia, New Zealand, ...
System failures or human carelessness can cause circumstances leading to temperature excursions. The most significant environmental condition having the capacity to affect the nature of the pharmaceutical product is temperature. If the temperature excursions are not taken care of efficiently, there will be an adverse impact on product quality. There is a developing need to ...
ByAKCP
The primary topics we explored are: Regulatory, Surround Areas, Cleaning, Process Interventions and Environmental Monitoring. Here we will talk about when these actions should take place, who should perform them, and what documentation and other activities may be necessary to ensure that you enjoy the quality and contamination control benefits of a well-designed ...
In the next blog in this series we will examine what Environmental Monitoring on a new fill line looks like with and without QbD implemented at the design phase. ...
International experts met to share their knowledge and expertise of regulatory requirements and practical applications pertaining to contamination monitoring and control systems for aseptic processes and clean environments. The three-day course focused on designing an effective monitoring strategy for aseptic/sterile products and processes. Pharma Industry ...
Maybe you’re wondering if all automated monitoring methods are equally acceptable to Regulatory Authorities? Regulatory bodies do not indicate which architecture is preferred in an environmental monitoring system, but they do ask for users to be compliant with the applicable governing bodies (21CFR11, EU GMP Annex 11, etc.), to have ...
Your contamination control strategy should document the quality of the materials in terms of microbiological monitoring or other requirements. The bioburden assay should be performed for each batch for both aseptically-filled products and terminally-sterilized products. ...
The updated document sets a milestone for adjustments needed within European agencies overseeing regulatory applications of drug products, and environmental monitoring in sterile manufacturing. Some of the top-level changes include: After the patchwork of changes made to the 2008 version, the organization of the content has improved to be more accessible and ...
Both Pharmaceutical Net and FacilityPro software provide data management from your particle counters, microbial monitors, and other sensors. The primary reasons you should upgrade to the FacilityPro Environmental Monitoring System: Data Integrity – Ensures accurate, unaltered data collection records Design Simplicity – Organizes ...
Abstract Now is the time to improve older automated industrial architecture and meet regulatory guidelines with the FacilityPro Environmental Monitoring System. Beneficial impact encompasses QA/QC, production, IT and operator functions, with expansion to microbial collection integration, report and audit trail capability, and the option for system redundancy. ...
Several key points, including but not limited to process design, bioburden control, and environmental monitoring (EM) are considered alongside this endeavor. By implementing the best practices dependent on these factors, sterile filtration prior to filling can be ...
US Nuclear has enjoyed a long-standing financial history of stable sales and modest profitability, but in 2017 the perfect storm or new and sustained growth spawned a sales increase of 50% with several new very large opportunities blossoming in the large and underserved radioisotope market, and the environmental monitoring market that is forecast to hit $20 ...