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Safe Sharps Handling When Dispensing Investigational Products

Advarra

However, when preparing an investigational product (IP) in a drug room or pharmacy, you need to recap the syringe and transport it to the clinic for injection. All potentially infectious sharps must be disposed of in a biohazard sharps container immediately after use without recapping. Needles must not be bent or sheared.

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Thinking About the Box: Considerations for Transport of Investigational Products

Advarra

Ensuring the safe and secure transport of investigational products (IP) is a core part of biosafety. Requirements for Transport of Investigational Products Accidents can happen. And don’t forget to affix a biohazard sticker to the exterior for quick and clear identification.

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Clean Bench vs Biosafety Cabinet: What’s the Difference?

Advarra

Biosafety cabinets (BSCs) protect the product as well as the user and the environment. The hood also blows sterile (HEPA filtered air) from the top down towards the work surface to protect the product from contamination with non-sterile ambient room air. . What is a Biosafety Cabinet? They operate under negative air pressure (i.e.,

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?5 Things You Need to Know from Our Recent Gene Therapy Webinar

Worldwide Clinical Trials

This data is important for informing the safety of an investigational product and will only be found if we continue to increase the diversity of clinical trials. Institutional Biosafety Committees (IBC) assess the risk of gene therapies to public health or the environment.

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Amazon Gets Green Light from FDA to Sell COVID-19 Tests Directly to Consumers

XTalks

The test is indicated for use as a direct-to-consumer (DTC) product for testing anterior nasal swab specimens self-collected at home using the Amazon COVID-19 test collection kit DTC. The FDA authorization also allows for pooled sample testing with up to five individual nasal swab specimens allowable per sample pool.

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IBC vs. IRB: What’s the Difference?

Advarra

IBCs, however, seek to protect study personnel, the community, and the environment from exposure to engineered genetic material and other biohazardous agents. IRBs are tasked with protecting research subject’s rights and welfare. IBC membership must include involving two local community members who reside within 50 miles of the research site.

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Nanomilling: How the latest Dynamic Light Scattering (DLS) technology could revolutionise hydrophobic API production

Pharmaceutical Technology

However, stopping nucleation and growth is challenging and often involves the use of biohazardous substances. The second is the “top-down” approach during which an initial micrometre-sized product is processed to reduce its size down into the nano-range using bead milling. Further scaling-up is delicate and laborious.