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Institutional biosafety committees (IBCs) frequently receive questions about the proper methodology for preparing a syringe for transport from a drug room or pharmacy to the clinic where the injection will be administered. Healthcare workers are frequently taught never to recap syringes after use. Needles must not be bent or sheared.
IBCs, however, seek to protect study personnel, the community, and the environment from exposure to engineered genetic material and other biohazardous agents. Food and Drug Administration (FDA ) and Office for Human Research Protections (OHRP) regulations require IRB review for research involving human subjects.
They provide sterile air to prevent environmental contamination of the investigational product and sterilize the exhaust air to prevent occupational exposure and environmental release of the drug. Work surfaces, such as the horizontal surface inside the BSCs, must be disinfected following work or spills involving biohazardous materials.
With its burgeoning list of Prime Day deals, Amazon has now received emergency use authorization from the US Food and Drug Administration (FDA) to add its COVID-19 test to its Prime offerings. Yes, that’s right, Amazon has developed its own COVID-19 test that consumers can now add to their shopping carts.
However, stopping nucleation and growth is challenging and often involves the use of biohazardous substances. Overcoming the process limitations of wet nanomilling for pharmaceutical drug substances. Further scaling-up is delicate and laborious. Free Whitepaper.
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