Drug delivery systems with sealed and sterile fluid paths and methods of providing the same
The present disclosure relates generally to the field of drug delivery. In particular, the present disclosure relates to a drug delivery system that includes a sealed and sterile fluid path attached to a drug-loaded container. The disclosure further relates to methods for sterilizing a portion of the drug delivery system without exposing the drug-loaded container to harmful sterilization parameters.
1. A method, comprising:
positioning a shield between an energy source and a drug delivery system, the drug delivery system comprising a container, a fluid path, and a cover, the container holding a liquid drug, a first end of the fluid path within the container, and a second end of the fluid path within the cover;
emitting energy from the energy source;
exposing the fluid path to the energy emitted by the energy source to sterilize the fluid path; and
blocking exposure of the liquid drug to a substantial portion of the energy emitted by the energy source.
2. The method of claim 1 , further comprising positioning the first end of the fluid path within the container.
3. The method of claim 1 , further comprising positioning the second end of the fluid path within the cover.
4. The method of claim 1 , wherein positioning the shield comprises positioning an aluminum shield having a thickness of at least 30 mm between the drug delivery system and the energy source.
5. The method of claim 1 , further comprising sterilizing the liquid drug prior to sterilizing the fluid path.
6. The method of claim 1 , further comprising piercing a cap sealing the container with the first end of the fluid path to couple the liquid drug to the fluid path upon activation by a user.
7. The method of claim 6 , further comprising piercing a septum sealing the container with the first end of the fluid path to couple the liquid drug to the fluid path upon activation by a user.
8. The method of claim 1 , further comprising piercing a plunger sealing the container with the first end of the fluid path to couple the liquid drug to the fluid path upon activation by a user.
9. The method of claim 1 , wherein positioning the shield comprises placing the fluid path and the container within a first shield component having an exposure window and coupling a second shield component to the first shield component.
10. The method of claim 1 , wherein emitting energy comprises emitting x-ray energy from the energy source.
11. The method of claim 1 , wherein emitting energy comprises emitting γ-ray energy from the energy source.
12. The method of claim 1 , wherein emitting energy comprises emitting electrical-beam energy from the energy source.