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Quality issues in medical devices often point to underlying weaknesses in the system, and ISO 13485-compliant CAPA is essential for correctly identifying cause and preventing the problem from recurring. Here’s an overview of CAPA requirements in ISO 13485 for medical device ...
In modern biopharmaceutical manufacturing, downstream processing development has become one of the most critical and resource-intensive stages. While upstream cell culture or fermentation focuses on producing the target biomolecule, downstream steps transform crude harvests into highly purified and stable therapeutic products. For biologics such as monoclonal antibodies, recombinant proteins, and ...
Whether it is medical research or drug manufacturing, tablet press is a vital link. Let's see how to choose the one that suits you best.Grand pack.The field of drug delivery is constantly evolving, driven by the core goal of improving therapeutic outcomes—enhancing efficacy, reducing toxicity, boosting patient compliance, and even enabling entirely new medical treatments. The global drug delivery ...
A nurse works late, spending hours manually logging incident reports instead of caring for patients. A hospital administrator wrestling with scattered spreadsheets, trying to prepare for an audit that’s days away. Sound familiar? These time traps can be difficult to avoid in private healthcare. However, every minute lost to administrative inefficiencies is valuable time lost for ...
Dubai, a global hub for innovation and technology, is rapidly adopting RFID (Radio Frequency Identification) solutions across various industries. From asset management to retail, healthcare, and logistics, businesses in Dubai are leveraging RFID technology to streamline operations, enhance security, and improve efficiency. This blog explores how RFID solutions are transforming businesses in Dubai ...
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 ...
The pharmaceutical industry has always been at the forefront of innovation, and automation has played a vital role in driving the industry forward. With an increasing demand for pharmaceutical products, there has been a need for faster and more efficient packaging solutions on a commercial scale. Pharmacy packaging automation is an effective solution to meet this demand. Read on to explore ...
Ion chromatography and sample filtration go hand-in-hand since this pretreatment step is advised for the majority of sample matrices. It is essential to avoid injecting particles, algae, or bacteria into the IC system, as these can jeopardize both the instrument and the separation column. Samples are often prepared manually, for example by using filtration or centrifugation to remove contaminants ...
ByB&W Tek
Come and see an automated biologics processing unit in operation at a one-day Symposium “Integrated Process Strategies For Regional Biopharmaceutical Supply” on March 28, 2023, Sedgefield, UK. Looking back down the race circuit, the horses don’t seem to be moving quickly – until they come thundering past you, covering twice my height in one effortless stride. We can ...
Creating good quality annotated case report forms (CRFs) takes time and attention to detail. While it can feel overwhelming, it shouldn’t stop you. Annotated CRFs (aCRFs) are a mandatory requirement of the Food and Drug Administration (FDA), and therefore a key submission deliverable for any clinical trial. So, it’s important to understand what regulatory and industry guidelines ...
ByFormedix
Biliary disease is a term used to describe diseases that affect the biliary system, which can result in inflammation, fibrosis, bile duct destruction, and eventually liver failure. It also frequently leads to secondary infections and chronic irritation, such as bile duct stones, which can lead to malignant tumors. There is currently no cure for biliary tract diseases other than liver ...
Summary OTraces in collaboration with the Gertsen Institute in Moscow performed a blinded validation study on OTraces breast cancer detection products, the CDx Chemistry System for processing automated tests for detection of cancer; BC Sera Dx Immunochemistry test kit for the measurements of proteins that are predictive as a group of the presence on breast cancer in women; and the OTraces Cancer ...
Situation When the Covid-19 pandemic began, businesses large and small had to move quickly to protect their workforce. By April 2020, widespread government mandates and regulations were put in place for companies to remain operational. The first hurdle for businesses was the sudden need for logging employee temperatures, symptoms, travel to hotspots, Covid-19 exposure, and communicating mask ...
ByRedlist
Automation now eases manual processes in so many aspects of society, from smart home switches to manufacturing lines. It’s also helping those working in molecular biology, biotech and pharmaceuticals to find new efficiencies and cost savings. So why consider an upgrade from manual pipetting in your lab? ...
The pressure on clinical laboratories has increased significantly in recent years and the need for fast, accurate and thorough data is reaching unprecedented levels. COVID-19 has put an intense spotlight on automated liquid handling systems in particular, and with worldwide reliance and investment in PCR testing capabilities, this insatiable demand for rapid testing is unlikely to dissipate soon. ...
Since baby elephants are still in the growing process, it's impossible to estimate the impact of eating a particular fruit on their trunk's length. ...
The demand for research and MEDICAL DIAGNOSTIC products grows annually. Because medical diagnostic devices are used in the testing, treatment, prevention, monitoring, studying, and diagnosis of diseases and other biological human conditions, companies that develop and manufacture such diagnostic products are well positioned to serve an important and vital role in health and healthcare, the ...
Close to 200 machine learning-powered startups applied to the ML Elevate programme, hosted by YourStory and AWS in association with Intel and Nexus Venture Partners, when it was first launched in October 2020. Early-stage startups on the lookout for a combination of tools, resources and insights necessary to build,grow and scale their startup to new heights formed the majority of applicants to ...
As Covid-19 counts continue to rise in North America, Europe and throughout the world, the potential for a vaccine comes at a critical time as scientists seek to prevent transmission of the virus by individuals already infected. On November 9, 2020, Pfizer and BioNTech announced that their trial of a Covid-19 vaccine showed a 90% efficacy rate and very promising results in participants who ...
Sepsis accounts for over 20% of deaths worldwide (WHO) and 85% of cases occur in low-resource settings.But this isn’t a problem mostly owned by third-world countries with inadequate equipment and detection technology. In the U.S., less than 50% of patients are correctly treated for sepsis, mostly due to clinicians missing the timeline for treatment. The problem is so widespread that ...