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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. Controlled Environment and IP Containment The potential for a release, and the risk associated with a genetically engineered IP, are part of the IBC’s assessment purview under National Institutes of Health (NIH) Guidelines.

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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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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. The IBC’s review is intended to ensure a thorough risk assessment is performed regarding the risks associated with the genetically modified materials.