Thinking About the Box: Considerations for Transport of Investigational Products

Ensuring the safe and secure transport of investigational products (IP) is a core part of biosafety. This critical task requires meticulous planning and rigorous procedures to avoid any hazards potentially arising during the journey of an IP from the controlled environment of a pharmacy or preparation room to its destination.

Think about the familiar paths we traverse every day of our lives. I’m a runner, and there are sections of my neighborhood I’ve crossed numerous times. But a distracting thought (or a speeding squirrel) can change that familiar territory without warning, causing me to trip and fall.

It’s the same with the transport of an IP. Even if the environment is familiar, with or without hazards, the unknown or unlikely is a biosafety consideration.

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.

When the IP leaves the controlled environment of a pharmacy or preparation room, IP’s containment effectively becomes the controlled environment in itself. The containment must then prevent spills or leaks if the IP is dropped. This is a matter of protecting not just the IP’s integrity, but also the safety of employees, the community, and the environment from any adverse effects (AEs) potentially resulting from an accidental release.

Therefore, using the appropriate transport container is essential to prevent spills or releases. Even if you’re just traveling a familiar path across the hall, the unknown can still trip things up.

Requirements for Transport of Investigational Products

Accidents can happen. So, how do we ensure the transport container for an IP is up to this crucial task? Here are some fundamental guidelines:

• The transport container should be sealed and leak-proof. Glass can easily shatter – plastic containers are the preferred choice. They’re sturdy, less likely to break, and can be easily decontaminated and cleaned after use.
  

• A sealed container prevents leaks of any liquids or aerosols, so look for an O-ring or a sealing component in the lid. A secure latch is crucial to create a tight seal; it ensures the lid stays put and the contents remain safely inside, even if the container takes a tumble.
  
• Size matters. Choose a container appropriately sized for its contents. And don’t forget to affix a biohazard sticker to the exterior for quick and clear identification.
• Some institutions require additional specific paperwork, so be sure to review internal policies prior to transport of the investigational products.
• If your IP is headed to a satellite location in a vehicle, you’ll need to follow the Department of Transportation (DOT) Hazardous Materials Regulation 49 CFR Parts 171-180, which allows for “in commerce” transport of materials or under the Materials of Trade (49 CFR 173.6)

Transport in a vehicle requires additional considerations such as:

• Preventing the transport container from shifting enroute by securing an external container within the vehicle.
• Maintaining the correct temperature for the IP, which may include using dry ice, wet ice, or heating packs.
• Preparing for unforeseeable release with a small spill kit.
• Maintaining the appropriate paperwork and labeling to identify the material’s hazards.

In conclusion, whether you’ve been conducting clinical trials involving recombinant nucleic acids for years or are just beginning to navigate the NIH Guidelines, your site should always assess transport procedures.

Using an appropriately sized, sealed, leak-proof container is best practice for transport from across the hall, within a building, or across a short distance to a satellite clinic. This is also the minimum requirement for transport under NIH Guidelines.

Safely and securely transporting an IP is a shared responsibility, requiring constant vigilance and a commitment to ongoing learning and adaptation.

Moving IP from a controlled environment means taking it to an area with increased risk of release and exposure. Remember, we’re not merely moving materials from point A to point B—we’re playing an essential role in the advancement of human health. Let’s ensure we do so safely and responsibly.

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