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Environmental Management And Monitoring Articles & Analysis
27 articles found
Operational Taxonomic Units (OTUs) serve as fundamental units in the realm of numerical taxonomy, particularly in the study of microbial ecology. These units can represent various biological classifications, including individuals, species, genera, or even higher taxonomic levels. The term "operational taxonomic unit" was introduced to address the discrepancies between traditional taxonomic ...
Optical Rotatory Dispersion (ORD) and Circular Dichroism (CD) are two important techniques widely used in the study of biomolecules, particularly the structure of proteins and nucleic acids. These techniques are based on the interaction of molecules with light, specifically how the molecules affect plane-polarized light that passes through them.Optical Rotatory Dispersion1. FundamentalsORD is ...
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 ...
This requires trained personnel who understand the importance of temperature control, efficient management procedures that ensure timely deliveries, and a robust feedback system that can quickly identify and rectify issues. ...
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 ...
What is metatranscriptomic sequencing? 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 ...
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 ...
Airborne detection of COVID-19 can be used by medical centers, schools, and other locations to safely reopen. 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. Find out more about the BioFlash To see video, please ...
Soil Generic Assessment Criteria for Human Health Risk Assessment is a technique used to examine the dangers which result from the release of pollutants into the land. The risks are identified and the likely impact of damage determined. Generic Assessment Criteria (GAC) in the United Kingdom aims at supplementing the Soil Guideline Values (SGV) which were established by the Environment Agency of ...
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 ...
A determination must be made about how to manage the removable parts with respect to the following categories: Cleaning – Is clean in place enough, are they removable? ...
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. ...
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 ...
All starting materials should have minimal microbiological contamination. 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. Use the results as part of the final batch review. ...
The European Medicines Agency (EMA) implemented the post-approval change management protocol and the possibility to request a “scientific advice meeting” with experts. ...
Both Pharmaceutical Net and FacilityPro software provide data management from your particle counters, microbial monitors, and other sensors. ...
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. The upgrade is a streamlined process ...
Abstract A non-sterile nasal spray production process is presented and examined with the aim of eliminating the gamma terminal sterilization step. 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 ...
Good News for Cancer and Heart Disease Patients: US Nuclear Partner Achieves Critical Milestone Proving New Way to Fill Multi-Billion/Year Shortage of Radioisotopes for Diagnostics and Treatments The National Academies of Sciences, Engineering and Medicine warns about severe shortages of radioisotopes that are required to non-invasively diagnose heart disease, cancer, other health issues, and ...
