An example sterilization indicator (102) includes a cover (122), an indicator (102), and a seal (142). The cover (122) defines at least a portion of a cavity (138). The indicator (102) is disposed within the cavity (138). The indicator (102) is configured to fluidly couple with an internal cavity (110) of a sterilization package (package) and indicate an exposure to a sterilant. The seal (142) is configured to form a microorganism barrier between an exterior of the cover (122) and an internal cavity (110) of a sterilization package (100).

A reusable respirator including a mask adapted for covering and conforming to the face around the nose and a mouth of a user, a strap configured to secure the mask to a face of the user, and a filter component. All components of the respirator are capable of being cleaned, disinfected and sterilized at temperatures in excess of 50° C. An outer surface of the mask is substantially smooth and wettable for easily disinfecting and is shaped with a pair of outer shield portions for housing particulate air filters. The outer shield portions each include a closeable vent through the outer surface that is adapted to provide a user seal check and direct air flow through the outer surface for filtering by the respective particulate air filter, which is adapted to filter at least 95% of airborne particles.

A device for production and use of a disinfectant. The device may be used to disinfect materials or objects exposed to viruses and/or bacteria. In particular, the device is capable of converting at least one first reagent such as an alcohol and at least one second reagent including an oxidant into an active disinfectant agent. A catalytic system is incorporated into the reaction vessel to produce the active disinfectant as needed for the disinfection process.

A sterile Intracervical Insemination (ICI) fertility kit, method of sterilization, and method of use for performing self-insemination. Each sterile kit comprises: up to three sets of individually wrapped sterile, disposable, syringes and semen collection jars; printed instructions; and a QR code. The collection jar comprises a snap-on lid, and an inner surface with seamless edges to prevent semen residue. The syringes and jars are sealed in plastic wraps permeable to air and gas, and impermeable to pathogens; and are sterilized via gamma radiation or ethylene oxide. Fresh or frozen, unwashed or washed, semen is deposited into the jar, pulled into the syringe, and administered cervically during a user's maximum monthly level of luteinizing hormone. The syringe distal end is designed to push all semen out of the syringe then plug the end closed, while preventing semen residue from collecting within the syringe. Large circular syringe handles facilitate stable handling.

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

The present invention concerns a tissue-engineered medical device, as well as a method for the production said medical device, comprising the following steps: providing a polymer scaffold comprising a mesh comprising polyglycolic acid, and a coating comprising poly-4-hydroxybutyrate; application of a cell suspension containing preferably human cells to the polymer scaffold; placement of the seeded polymer scaffold in a bioreactor and mechanical stimulation by exposure to a pulsatile flux of incremental intensity, thereby forming an extracellular matrix; mounting of the graft on a conduit stabilizer and incubation in cell culture medium; decellularisation of the graft in a washing solution; nuclease treatment of the graft; and rinsing of graft. The invention further comprises and various steps of quality control of the tissue-engineered medical device.

Systems and methods for providing a magnetic fluid (MF) seal suitable for a fluid environment may provide a shaft and a magnet that is cylindrical or ring-shaped. A magnetic fluid may be present between the magnet and shaft. Additionally, pole pieces may also be provided, which are also cylindrical or ring-shaped. These pole pieces are positioned on the shaft so the magnet is sandwiched between the pole pieces. The magnet, pole pieces, and shaft, if magnetic, may attract and retain the magnetic fluid in an annular gap or region between the shaft and the magnet and/or the pole pieces. The magnetic fluid in the annular gap serves as a seal or barrier that prevents fluid from passing through when pressure is below a predetermined level.

A method of sterilizing a prefilled syringe comprises assembling a syringe assembly and performing at least one ethylene oxide (EtO) sterilization procedure cycle. The assembling step includes inserting a tip cap at a first end of a plunger, filling a non-glass barrel with sterilization sensitive material at a second end of the barrel, and inserting the plunger into the barrel at a second end to seal the sterilization sensitive material within the barrel. The EtO sterilization procedure cycle comprises undergoing a preprocessing stage, a wash and conditioning stage, an EtO sterilization stage and a wash and post exposure stage. Upon completing the EtO sterilization procedure cycle, a resultant pH of the sterilization-sensitive material does not exceed an acceptable pH range as defined by the United States Pharmacopeia. The disclosure also discusses inserting an assembled prefilled syringe into a procedure tray prior to performing the EtO sterilization procedure cycle.

A decontamination system for a device, such as a lumen device, is provided. The decontamination system includes a terminal package defining a device receiving area. The terminal package includes a fluid inlet through which sterilant fluid can be delivered to the device receiving area. An accumulator apparatus is provided that is configured to switch between trapping sterilant fluid delivered into the device receiving area and delivering sterilant fluid to the device receiving area based on pressure changes in the device receiving area.

Drug delivery devices, sealing members for containers housed within such drug delivery devices, and related methods of assembly are disclosed. The drug delivery device may include a housing, a container disposed in the housing and having an interior volume, a drug disposed in the interior volume, and a septum. The container may have an opening formed in an end surface and which communicates with the interior volume. The septum may include a proximal end inserted through the opening into the interior volume of the container. Additionally, the septum may include a distal end having a flange disposed outwardly of the proximal end and contacting the end surface of the container. At least an end portion of the flange may be made of a material that is permeable to a gaseous sterilizing agent.