A sterile packaging unit includes a disposable bioprocessing component (20) and a packaging (30). The disposable bioprocessing component (20) has a component wall that encloses a processing space and on which is secured a sensor system (40) with at least one sensor head (T, P, I, L, D) and with attached sensor electronics (42) that include a memory unit (44). The packaging (30) hermetically encloses the disposable bioprocessing component (20) and has a flexible packaging wall. The disposable bioprocessing component (20) and the packaging (30). are sterilized by being jointly irradiated with ionizing radiation. The sensor electronics (42) are connected electrically to a contact unit (34) extending through the packaging wall.

A barrier layer and corresponding method of making provide anti-inflammatory, non-inflammatory, and anti-adhesion functionality for a medical device implantable in a patient. The barrier layer can be combined with a medical device structure to provide anti-adhesion characteristics, in addition to improved healing, non-inflammatory, and anti-inflammatory response. The barrier layer is generally formed of a naturally occurring oil, or an oil composition formed in part of a naturally occurring oil, that is at least partially cured forming a cross-linked gel. In addition, the oil composition can include a therapeutic agent component, such as a drug or other bioactive agent.

A cellulose-containing article for treating an area of skin, wherein the article comprises BNC in an amount of at least 1% by weight and at most 15% by weight, comprises fluid in an amount of at least 85% by weight and at most 99% by weight, has an average thickness of at least 0.5 mm and at most 8 mm, wherein the BNC is of microbial origin.

The present invention relates to a method and system for aseptically filling of flexible packages containing dry cloth. Such a method may include a first stage that is performed in a non-sterile environment. The first stage may include cutting a first substantially dry cloth to a predetermined size; inserting the first cloth into a flexible package; sealing a first end of the flexible package; and sterilizing the flexible package. The method may also include a second stage performed in a sterile environment. The second stage may include filling the flexible package with a medical solution such that the substantially dry cloth absorbs at least a portion of the medical solution; and sealing the open end of the flexible package.

A method for validating a method for sterilizing an item, making it possible to validate the sterility assurance level achieved with this sterilization method. The method includes carrying out a first step of contaminating a container receiving the item with more than 10.sup.5 living microorganism cells, then carrying out a first sterilization cycle with the chosen method, then opening the container in order to contaminate it again with more than 10.sup.5 living microorganism cells, then carrying out a second sterilization cycle with the same method, and finally checking the sterility of the container after the first sterilization cycle and after the second sterilization cycle. The method is applicable in particular for products and devices intended for health use.

Provided herein is a pre-Caesarean method for collecting amniotic fluid from a patient. A needle is inserted into the incision site for the future C-section, which may be under ultrasound guidance, through which the amniotic fluid is drawn under a low level suction and, optionally, gravity to a sterile collection container. The method encompasses filtering and/or irradiating the amniotic fluid to collect biomolecules of interest such as growth factors and/or stem cells. Also provided is the sterile amniotic fluid or filtrates thereof collected by the method described herein.

Apparatus and methods for delivering medicament to a patient. The apparatus may include elements with different capacities to attenuate or absorb sterilizing radiation. The apparatus may include a medicament delivery assembly with interactive elements for dose-setting, priming and medicament ejection. The assembly may include a chamber housing a radiation-sensitive medicament present in the apparatus during sterilization by electron beam. The assembly may include an actuator chassis, a drive mechanism, a needle-priming mechanism and a fluid-displacement mechanism including a fluid-displacement member. The chassis may be fixed, relative to an outlet, to the chamber. The member may be slidingly and/or threadingly engaged with the chassis, and may be configured to move relative to the outlet to deliver the medicament through the outlet. Assembly elements may be nested coaxially and/or stacked axially. The assembly may include at least one hollow region. The hollow region may reduce beam attenuation or reduce radiation absorption.

A surgical instrument is disclosed including a transducer configured to provide vibrations along a longitudinal axis, an end effector operably coupled to the transducer, and a stationary lower jaw extending parallel to the end effector. The end effector extends along the longitudinal axis. The end effector comprises a blade. The stationary lower jaw comprises a clamp face positioned distal to the blade. The end effector is movable relative to the stationary lower jaw to drive the blade distally towards the clamp face. The end effector comprises a hollow lumen. The end effector further comprises at least one member extended across a portion of the hollow lumen.

An apparatus includes a radiation source configured to emit a radiation along an irradiation volume, and a conveyor configured to drive goods loaded in two or more transport units through the irradiation volume so as to expose a first portion of the goods to the radiation. The transport units may be loaded in totes of a tote height, and the conveyor may be configured to drive the totes. The totes may be arranged on top of one another, and each transport unit may be held in place in a tote by one or more support elements such that a total height of the totes is between 40% and 100% of the tote height, the transport units are loaded in a tote span over at least 70% of the total height, and the total height is centered relative to the tote height within about 20%.

An on-body injector system includes a drug container assembly including a container, a seal member, and a sealing interface between the seal member and the container. The container includes an opening and the seal member at least partially covers the opening in the container. A fluid pathway assembly is coupled to the drug container assembly and includes a needle that is movable between a storage position, in which a point of the needle is spaced from the seal member, and a delivery position, in which the point of the needle is disposed at least partially through the seal member. A radiation generator is configured to emit rays of radiation to sterilize and/or disinfect the sealing interface. A barrier is disposed adjacent to the sealing interface and has an opening. At least a portion of the drug container assembly is positioned adjacent to the opening in the barrier.