A flexible, sterilizable pouch includes a first gas-impermeable web, a second gas-permeable web, and the third gas-impermeable web. The webs are arranged and sealed to form a cavity portion of the pouch and a header portion of the pouch. The header portion of the pouch is gas-permeable through the second gas-permeable web. The cavity portion of the pouch is configured to hold a medical device for sterilization and is configured to be sealed from the header portion after sterilization, thereby making the cavity portion gas-impermeable. The header is also configured to be removed from the pouch, leaving the cavity portion.

The invention discloses a sterile syringe (100) comprising a barrel (1) having internal surfaces (2), a plunger (3) movable within the barrel, a non-sliding seal (7) between the barrel and the plunger defining a sealed volume (8) and at least one filter (9) allowing only filtered gases to enter the sealed volume such that the syringe maintains its sterility even after several uses. The filters could be positioned on different locations on the syringe like on the non-sliding seal, the barrel, the barrel flange or the plunger handle.

A decontamination system, method, and sterilant kit for a device, such as a lumen device, is depicted. The decontamination system, in some embodiments, includes a device container, a wicking pad, and a sterilant fluid delivery device. The device container, such as a terminal package or a decontamination chamber, defines a device receiving area. The wicking pad is in fluid communication with the device receiving area. The sterilant fluid delivery device is in fluid communication with the wicking pad. The sterilant fluid delivery device is configured to wet the wicking pad with sterilant fluid. The wicking pad is configured to evaporate sterilant fluid into the device receiving area.

Syringe assemblies comprising a first cap and a second cap to ensure sterilization of the fluid path without the need for external packaging are described. Also described are methods of sterilizing the fluid path of a syringe assembly.

A gas sterilizable syringe includes an enclosure having walls that define a fluid chamber. A flowable material is disposed within the fluid chamber of the enclosure. A plunger is assembled with the enclosure and is moveable toward a distal end of the enclosure for dispensing the flowable material. One or more apertures are formed in at least one of the walls of the enclosure. A gas permeable barrier covers at least one of the apertures formed in at least one of the walls of the enclosure for enabling sterilization gases to pass through the at least one aperture covered by the gas permeable barrier while preventing the flowable material from passing through the at least one of aperture. The gas permeable barrier is permeable to the sterilization gases and impermeable to the flowable material disposed within the fluid chamber of the enclosure.

The present disclosure provides an ethylene oxide sterilization sensor and method of use. The sensor includes: at least one thermal indicator component independently selected from an electronic thermal sensor, an irreversible temperature indicator, and a heat-shrinkable film; an acid-functional porous sorbent or an acid-functional nonwoven fibrous substrate in thermal contact with the at least one thermal indicator component; and an acid having a boiling point above 120° C. and a pKa of no greater than 2.5. The acid is impregnated in or covalently attached to the porous sorbent or is covalently attached to the nonwoven fibrous substrate. The sensor includes at least one of the electronic thermal sensor, the irreversible temperature indicator, or the acid-functional nonwoven fibrous substrate.

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.

Seal integrity indicators for sterilization containers are provided. For example, a seal indicator may indicate whether the container is sufficiently sealed to prevent an ingress of contaminants into the container. If the container is sufficiently sealed, the seal indicator is visible, but if not, the seal indicator is not visible. Thus, the seal indicator undergoes a change in state when the sterilization container transitions from unsealed to sealed, or vice versa, such that a user may ascertain whether the container is properly sealed to maintain the container's sterility. An exemplary seal indicator includes an invertible projection formed with the container gasket that is not visible from outside the container until inverted, due to force applied by the lid, to extend through an opening in the container body. Closure mechanisms for sterilization containers also are provided.

A biological indicator (100) for use in a liquid-chemical decontamination system is disclosed. The biological indicator may include a housing (102) and a cap (106) coupled to the housing. The cap may comprise a liquid chamber and at least two ports. One of the ports may connect to a liquid passage in the cap such that liquids such as liquid-chemical decontaminants may be introduced and removed from the biological indicator via this port.

A processing system including at least one processor may obtain information regarding an exchange of an item, the exchange having a sterilization requirement for the exchange, and may identify a network-connected storage locker having at least one sterilization component that is capable of fulfilling the sterilization requirement and that is available for assignment to the exchange. The processing system may then transmit a first notification to the network-connected storage locker of a reservation of the network-connected storage locker for the exchange and transmit to a computing system associated with a source of the item a second notification of the reservation of the network-connected storage locker for the exchange.