A method of preparing a prefilled syringe is disclosed that includes obtaining a syringe barrel and a needle adaptor cap assembled on the tip of the syringe barrel, wherein the needle adaptor cap has a rubber element tightly sealing the orifice of the tip of the syringe barrel and the syringe barrel together with the needle adaptor cap assembled on the tip of the syringe barrel is sterilized by a first sterilizing. Filling a drug substance into an interior of the syringe barrel and sealing the interior of the syringe barrel. Packaging the syringe barrel with a rubber stopper sealing the interior thereof and the needle adaptor cap assembled on the tip of the syringe barrel. Providing a second external surface sterilizing of the packaged syringe barrel with the rubber stopper sealing the interior thereof and the needle adaptor cap assembled on the tip of the syringe barrel.

Apparatus and a method are presented, including disinfecting a disinfection chamber that is defined between (i) a prefilled therapeutic substance reservoir and (ii) a sterile fluid path disposed within a therapeutic substance delivery device. The sterile fluid path includes a needle at an upstream end of the sterile fluid path and an injection assembly at a downstream end of the sterile fluid path. The disinfection occurs subsequently to the prefilled therapeutic substance reservoir being engaged with the therapeutic substance delivery device. Subsequently to disinfecting the disinfection chamber, the disinfection chamber and then the reservoir are penetrated with the needle. Other applications are also described.

A cap configured to disinfect a medical device or portion thereof, the cap comprising a power source that provides electric power, an electromagnetic radiation source that uses the electric power received from the power source to emit photons for disinfection and a switch that is configured to be operated by user action, wherein upon activation of the switch, the electric power from the power source is applied to the electromagnetic radiation source to radiate photons onto the medical device or portion thereof.

A medicant injection device includes a compressible body, a tip, and an outer luer body. The compressible body has a proximal end, a distal end, and a plurality of bellows, and defines an inner cavity for holding a liquid medicant. The tip is positioned at the proximal end of the compressible body. The outer luer body includes internal threads, and is positioned over and engaged with the tip to form a first fitting therewith. The first fitting is configured to be connected with a second fitting. A medicant injection device includes a compressible body having first and second arms, a receptacle interconnected with the compressible body and defining an inner cavity, and a first fitting configured to engage a second fitting. The compressible body is configured to be compressed by forcing the distal end of the first and second arm toward each other.

An assembly comprises a sealed drug reservoir unit, a subcutaneous flow conducting device in the form of a needle unit or an infusion set, and a flow communication unit. The flow communication unit comprises a proximal hollow needle adapted to penetrate a needle-penetrable septum of the reservoir, a first flow-way inflow communication with the proximal needle and comprising a pressure-controlled valve, a second flow-way in flow communication with the first flow-way, an amount of preservative arranged to react with a substance received by the second flow-way, and distal flow communication means adapted to provide flow communication between the second flow-way and the needle unit. A combined flow way can be established between the reservoir and the needle unit via the first and second flow-ways when the units are connected. The valve is controlled to open when the reservoir is pressurized, the preservative being provided to react with substances introduced to the second flow way via the needle unit.

According to embodiments, there is provided a medical apparatus including one or more sterile pre-filled syringe, one or more first protective container including the one or more sterile pre-filled syringe, wherein the first protective container may be completely or partially filled with an inert or non-inert gas, wherein the one or more first protective container is impermeable to moisture and/or sterilizing agents, and a second protective container including one or more medical components and the one or more first protective container, wherein the second protective container may be, but is not necessarily, completely or partially filled with an inert or non-inert gas. In some aspects, a package mostly impermeable to bacteria including the first and second protective containers is also completely or partially filled with an inert or non-inert gas.

A system for sterilizing a drug delivery device includes a drug delivery device having a first self-healing seal configured to seal a fluid reservoir disposed within the drug delivery device. A sealable container is configured to receive the drug delivery device therein. The sealable container has a base portion and a cover portion. The cover portion has a second self-healing seal positioned to align with the first self-healing seal when the drug delivery device is disposed within the sealable container. A fill port includes a fill path, the fill path being configured to pass through the first and second self-healing seals to fluidly couple the fill port to the reservoir of the drug delivery device. Other systems, methods, and devices of sterilization are also disclosed.

A protective cap having a first cap and a second cap that are removably coupled together for use in short-term and long-term antimicrobial treatment of needleless connectors and access ports of an infusion system. The instant invention further provides a protective cap having a first cap and a second cap that each coupled to a different surface of a component of an infusion system, such as a syringe. The instant invention further provides a strip containing a plurality of disposable protective caps.

The invention provides a syringe for use in an ophthalmic injection. The syringe comprises a body, a stopper and a plunger. The body comprises an outlet at an outlet end and the stopper is arranged within the body such that a front surface of the stopper and the body define a variable volume chamber from which a fluid can be expelled though the outlet. The plunger comprises a plunger contact surface at a first end and a rod extends between the plunger contact surface and a rear portion. The plunger contact surface is arranged to contact the stopper but not couple thereto, such that the plunger can be used to force the stopper towards the outlet end of the body, reducing the volume of the variable volume chamber, but not to move the stopper away from the outlet end.

A shielding member for use in sterilizing drug container assemblies includes a housing. The housing includes a first shielding portion and a second shielding portion. The first shielding portion includes a first and second surfaces and a plurality of first bore portions extending between. The second shielding portion having a first and second surfaces and a plurality of second bore portions corresponding to and aligned with the plurality of first bore portions. The first and second bore portions cooperate to form a plurality of receptacles including a plurality of openings in the first surface of the first shielding portion of the housing. The receptacles are sized and configured to receive drug container assemblies, each comprising a container with a container contact region and a seal member disposed adjacent the container contact region to seal the contents of the container at a sealing interface, such that each drug container assembly is exposed out of the housing through one of the openings.