Medical Device Cleanroom News
Get the latest Medical Device Cleanroom News and updates below. Cleanroom Connect brings you the latest Medical Device Cleanroom News from around the world, featuring current topics and news in the medical device industry.
With an aim to grow and further establish their international presence in pharmaceutical manufacturing, Wockhardt inaugurated a ‘state-of-the-art’ sterile dry powder injection cleanroom manufacturing facility for the production and packaging of sterile dry powder injection in Dubai. On approval of the new drug by US FDA, this manufacturing facility will be commissioned for commercial production.
Genomma Lab will be able to focus on lowering its production costs, and thus offering more affordable medicines and products across the region.”, said Mr Maximo Juda, CEO of the Company. “Both multi-lateral institutions will not only provide long-term financing but also key strategic advice given their extensive industry expertise in pharma and environmental matters”, added Mr. Antonio Zamora Galland, CFO of Genomma Lab
To streamline the oversight of manufacturers’ quality systems, and encourage improved product safety on a global scale, the International Medical Device Regulators Forum (IMDRF) has developed the Medical Device Single Audit Program (MDSAP) whereby recognized Auditing Organizations (AOs) conduct a single audit of a medical device manufacturer that satisfies the relevant requirements of various regulatory agencies.
The Atropine Autoinjector initially received Emergency Use Authorization from the FDA in April 2017. Atropine is one of the most commonly used drugs for the treatment of chemical nerve agent poisoning. With the approved Atropine Autoinjector, U.S. troops can rapidly inject atropine into the thigh muscle following nerve agent exposure.
Almac has manufactured multiple High Throughput batches of neoantigen derived peptides –branded by Almac as NeoPeptides™ – for compassionate use treatments, and for P-I clinical trials, from its Edinburgh facility. Over the course of the past ten months the facility has been upgraded and segregated to enable GMP supply.
Biosensors are devices that can detect biological molecules in air, water, or blood. They are widely used in drug development, medical diagnostics, and biological research. The growing need for continuous, real-time monitoring of biomarkers in diseases like diabetes is currently driving efforts to develop efficient and portable biosensor devices.
The Brock team’s latest technology builds on an earlier version of the microscopic robot — called the three-dimensional DNA nanomachine — they created in 2016 to detect diseases in a blood sample within 30 minutes.
Private equity firm Graham Partners has entered injection molded medical goods with an investment in Medbio LLC of Grand Rapids, Mich. Graham Partners acquired a majority interest in Medbio, effective July 18 for undisclosed terms, according to Graham managing principal Joe Heinmiller.
Scientists at the Mainz University Medical Center and the Max Planck Institute for Polymer Research (MPI-P) have developed a new method to enable miniature drug-filled nanocarriers to dock on to immune cells, which in turn attack tumors.
The dragonfly larva is the only insect that uses jet propulsion to move and the only arthropod known to use reciprocal jetting—inhaling and exhaling through the same orifice—for underwater breathing,” says Roh, the lead author of a paper on the larval jets that was published online by the journal Bioinspiration & Biomimeticson May 30.
the manufacturing facility was designed to achieve Leadership in Energy and Environmental Design (LEED) certification. Moderna is limiting energy use with advanced energy metering, LED lighting, and systems designed to reduce water usage by up to 25%.
Platforms for kidney exchanges such as the National Kidney Registry and the Alliance for Paired Donation provide a lifeline for people on the waiting list by expanding the pool of potential donors by matching potential recipients with living donors they’ve never met.
Medical Device Cleanroom News and Advancements
The Medical Device Cleanroom Industry supports the environmental cleanroom and controlled environmental systems for the Medical Device Cleanroom industry. The medical device industry is the study of medical apparatus, medical appliance, medical software, medical materials or other medical articles. Whether used in solidarity or in combination with technology or software. The Medical Device Cleanroom News curated on Cleanroom Connect specifically relates to new medical device trends, medical device products, medical device startups, and medical device innovations.
Medical Device Cleanroom News a key to Compliance
Common uses of medical devices are intended to be compliant by the specifications created by the original product manufacturer. These medical devices serve humans in the following circumstances:
- Disease Diagnosis, disease prevention, disease monitoring, or disease alleviation
- Injury diagnosis, injury treatment, injury monitoring, injury alleviation
- Physiological process monitoring, anatomy replacement or anatomy modification
- Technical administration of pharmaceutical agents, biologic agents, immunological agents
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