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 package comprises: a sterile barrier packaging film; self-sterilizing components comprising: a plurality of chlorite ions and water, wherein the self-sterilizing components are substantially free of an energy-activated catalyst and of an acid-releasing compound; a package interior formed by hermetically sealing the sterile barrier packaging film; and a headspace within the package interior comprising carbon dioxide present in an amount of greater than or equal to 5% by volume of the headspace. When the package is exposed to ultraviolet (UV) light having a wavelength of 254 nm, the chlorite ions react with the water to generate chlorine dioxide (ClO.sub.2), which is released into the headspace. In the absence of any UV light, there is not chlorine dioxide (ClO.sub.2) generation.

Novel, lubricious coatings for medical devices are disclosed. The coatings provide improved lubricity and durability and are readily applied in coating processes a low temperatures that do not deform the device. The present invention is also directed to a novel platinum catalyst for use in such coatings. The catalyst provides for rapid curing, while inhibiting cross-linking at ambient temperatures, thereby improving the production pot life of the coatings.

A cleanroom autoclave system including a reusable autoclave breather bag and a reusable fill line hopper cover. The autoclave bag is formed from a launderable abrasion resistant inner fabric layer and a launderable polyester outer fabric layer, and has a zipper closure. The hopper cover is formed from a circular bonnet and an open tubular skirt formed from a launderable polyester fabric, and includes an elastic portion and snaps to secure the hopper cover.

Provided is a storage device including a storage body for holding a liquid, a gas or an item, which has a first wall, a second wall, and a magnetic closure device for closing the storage body, which has a first closure part and a second closure part. The first closure part has a first strip body elongate along a transverse direction and is arranged on a first closing portion of the first wall. The second closure part has a second strip body elongate along a transverse direction and is arranged on a second closing portion of the second wall. The first closure part and the second closure part cooperate in a magnetically attracting manner. At least one of the first wall, the second wall, the first strip body and the second strip body are wholly or partly fabricated from a composition containing an antimicrobially active additive.

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.

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.

A fluid plug for use with sterile processes such as the manufacture or production of pharmaceuticals and biologics is disclosed. The fluid plug is made of a material or materials that will tolerate sterilizing processes such as gamma irradiation. The fluid plug is used to selectively plug the ends of flexible polymer conduits that may be connected to fluids, reagents, or products used or generated as part of the manufacturing process. Also disclosed is the use of the plugs in combination with a series of valves in a block-and-bleed arrangement to enable the sterile transfer and connection of fluids, reagents, or products within a process flow.

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 sterilizable pouch includes at least one sheet, wherein outer peripheral edges of the at least one sheet are sealed together to define a pouch having an interior space for receiving an article therein. A first releasable seam spans between a first peripheral edge of the at least one sheet to a second, opposite, peripheral edge of the at least one sheet, the first releasable seam dividing the at least one sheet into a first sheet part and a second sheet part. A second releasable seam and a third releasable seam each substantially span from a third peripheral edge of the at least one sheet to a fourth, opposite, peripheral edge of the at least one sheet and along the first peripheral edge and the second peripheral edge, respectively. The second and third releasable seams are arranged generally perpendicular to the first releasable seam, where the first, second and third releasable seams enable the pouch to be completely opened such that a device can be removed from the pouch without the device contacting non-sterile portions of the pouch.