A method of using a sterilization wrap system including a permeable material having barrier properties and having a first surface and a second opposing surface, the exterior panel being substantially opaque or having a first level of translucence, and an interior panel including a permeable material having barrier properties and having a first surface and a second opposing surface, the interior panel having a level of translucence that is higher than the translucence of the exterior panel, the panels being joined together over at least a portion of their surfaces. Also disclosed is inspection of the sterilization wrap system for exterior panel breaches by looking for light passing through a panel facing the viewer.

The present disclosure in one aspect provides a sterile packaging container comprising a container body with a cross-sectional shape that is constant along the majority of the longitudinal axis, a cover and a closure assembly that inhibits the passage of microbial contaminants. The container is configured such that the interior of the container can be sterilized. The sterile packaging container described herein allows one to manufacture a sterile packaging tube exercising the smallest possible volume.

The invention provides a sterilizable pouch having at least one wall formed of a flexible film and including an opening formed therein for providing communication to an interior space of the package. A breathable material is disposed on an outer surface of the wall covering the opening. The breathable material is joined to the outer surface of the wall with a continuous heat seal. The flexible film forming the wall comprises a multilayer film having a peel feature that permits the breathable material to be peelably removed from the surface of the pouch.

The present invention provides a platform, system and devices for testing or screening individuals for symptoms of disease, exposure to chemicals or biohazards. The device may be configured similar to the appearance of familiar airport screening devices, but may be configured for use in a people moving device or a walkway. The present device assays volatile compounds, especially volatile organic compounds (VOCs) emitting from a subject person, group or item. Different VOCs are produced dependent on metabolic changes in response to pathogenic, chemical, or biological stresses. Nanosensor elements within the device provide assessments of multiple VOCs to the platform with its integrated analysis capacities that rapidly compare instant data to a developed database. Each chamber may participate in an interconnected system sharing data for continuous improvement of assay procedures and comparison results.

A packaging comprising a tray having an opening, a cavity including at least three cavity portions, a plurality of sidewalls, and a base; and a sterile syringe contained within the cavity, wherein the sterile syringe is pre-filled with a medicament or other fluid; wherein a first cavity portion comprises a plunger rod of the sterile syringe, a second cavity portion comprises a barrel of the sterile syringe, and a third cavity portion comprises a needle attachment portion of the sterile syringe, wherein the at least three cavity portions are connected to one another by intermediate narrowed portions, and wherein each of the narrowed portions includes a first sidewall, a second sidewall, a base, and a plurality of geometric features projecting into the narrowed portions to position the sterile syringe away from the plurality of sidewalls.

There is provided a method and apparatus for operating a sterilization chamber such that one version of Programmable Logic Controller (PLC) software is compatible with any number of hardware configurations of the sterilization chamber. The PLC software is divided into a core module for operations which are the same across all hardware configurations, and a template module for hardware specific operations. Configuration data, state data, and live data are segregated from each other.

The system of the invention involves a gloveless aseptic processing system. The automated system is for filling nested pharmaceutical containers with a pharmaceutical fluid substance. A closed sterilizable gloveless isolator chamber is capable of maintaining an aseptic condition, having a sterilization system. The container filling system has a dispensing head for filling the containers, and a container closing system disposed within the gloveless isolator chamber with rams for pushing closures into openings of the nested containers. The container manipulation mechanism is disposed within the gloveless isolator chamber and is capable of positioning the nested pharmaceutical containers within the gloveless isolator chamber including operably disposing the nested pharmaceutical containers with the container filling system and the container closing system. Container tubs sealed by removable covers and contain a container nest bearing a plurality of pre-sterilized pharmaceutical containers.

The present disclosure relates to sterilization monitoring devices, as well as and methods and kits for evaluating sterilization processes using sterilization monitoring devices.

Aspects of the disclosure relate to “wet” transcatheter prosthetic heart valve or other implant packaging and assemblies in which a prosthetic heart valve or other implant is loaded into a first portion of a delivery device and positioned within a container in which sterilizing fluid is retained to sterilize inside of the container as well as provide moisture to prevent the implant from drying out. The disclosure also relates to methods of sterilizing the disclosed assemblies. Some disclosed methods include at least two sterilizing steps and adjustment of a shaft seal or formation of multiple seals maintaining sterilizing fluid within the container so that areas underneath the shaft seal(s) can also be sterilized.

The present invention comprises a sterilizing wrap system comprising a base having a support surface and a first sealing surface spaced from the support surface, the support surface supports at least one object requiring sterilization. A wrap is sized to engage the first sealing surface of the base to define a volume encompassing the support surface and the spaced first sealing surface of the base. A first seal maintains a sealed interface between the wrap and the first sealing surface.