This invention relates to a container comprising and outer shell and an inner lining, to a method of construction of such a container and to components used in the construction of such a container. A container comprises an outer shell made from a first material comprising paperboard, and an inner lining made from a second material comprising a polymeric or metallic material, the lining defining an internal volume for holding a liquid, and the lining being adhered to the shell, wherein, the outer shell includes a line of weakness extending around at least part of the periphery of the shell and defining a first portion of the shell on one side of said line and a second portion of the shell on the other side of said line, the line of weakness permitting the first portion of the shell to be separated from the second portion of the shell, and wherein, the lining is adhered to the shell in said first portion and the lining extends into to said second portion of the shell.

According to embodiments, there is provided a medical apparatus including one or more sterile pre-filled syringe, one or more first protective container including the one or more sterile pre-filled syringe, wherein the first protective container may be completely or partially filled with an inert or non-inert gas, wherein the one or more first protective container is impermeable to moisture and/or sterilizing agents, and a second protective container including one or more medical components and the one or more first protective container, wherein the second protective container may be, but is not necessarily, completely or partially filled with an inert or non-inert gas. In some aspects, a package mostly impermeable to bacteria including the first and second protective containers is also completely or partially filled with an inert or non-inert gas.

A sterile container including at least one hollow fiber filter module, especially dialyzer, which is accommodated in a hermetically sealed holding volume of a primary package and includes a blood compartment delimited by a blood inlet opening and a blood outlet opening, wherein a plurality of hollow fiber filter modules is arranged in the primary package and the sterile barrier of the blood compartment of each hollow fiber filter module inside the primary package is implemented by caps which close the blood inlet opening and the blood outlet opening of each hollow fiber filter module. A method of manufacturing such sterile container is also disclosed.

Provided herein are freeze-dried preparations comprising a high-purity parathyroid hormone (PTH) peptide and one or more PTH analogs, and methods for the production thereof. Also provided is a test method for detecting PTH analogs to confirm the purity of a freeze-dried preparation containing PTH peptide, and the like.

Provided herein are freeze-dried preparations comprising a high-purity parathyroid hormone (PTH) peptide and one or more PTH analogs, and methods for the production thereof. Also provided is a test method for detecting PTH analogs to confirm the purity of a freeze-dried preparation containing PTH peptide, and the like.

A controlled environment enclosure comprises a robotic arm manipulation system used to protect and unprotect a fluid path and a swab within the controlled environment enclosure. The apparatus allows the fluid path to be protected against dangerous decontamination vapors and chemicals before the controlled environment enclosure is decontaminated. The apparatus allows the fluid path to be unprotected without the use of gloves or other means that degrade the integrity of the controlled environment enclosure when decontamination is completed. The apparatus and method allow for the protecting, unprotecting and decontaminating sequences to be automated. In some embodiments the fluid path comprises a fill needle that can removably and aseptically be sealed with a disposable monolithic injection moulded polymeric fill needle sheath. The apparatus and method further allow for the use of a swab disposed in a swab holder that is aseptically and removably sealable to a swab cap to protect the swab against decontamination vapors.

A controlled environment enclosure comprises a robotic arm manipulation system used to protect and unprotect a fluid path and a swab within the controlled environment enclosure. The apparatus allows the fluid path to be protected against dangerous decontamination vapors and chemicals before the controlled environment enclosure is decontaminated. The apparatus allows the fluid path to be unprotected without the use of gloves or other means that degrade the integrity of the controlled environment enclosure when decontamination is completed. The apparatus and method allow for the protecting, unprotecting and decontaminating sequences to be automated. In some embodiments the fluid path comprises a fill needle that can removably and aseptically be sealed with a disposable monolithic injection moulded polymeric fill needle sheath. The apparatus and method further allow for the use of a swab disposed in a swab holder that is aseptically and removably sealable to a swab cap to protect the swab against decontamination vapors.

A surgical cutting and fastening instrument that includes an elongate channel that is attached to a handle assembly by an elongate shaft assembly. The elongate channel is configured to receive a cartridge and has a pivotally translatable anvil attached thereto and a knife bar supported therein. The anvil may be selectively opened and closed by manipulating a closure trigger supported by the handle assembly. The knife bar may be distally advanced through the elongate channel by actuating a firing trigger that cooperates with a reversible rotary drive supported by the handle assembly. The knife bar may also be retracted to its starting position by actuating the firing trigger after the reversible rotary drive has been shifted to a retraction orientation.

A surgical cutting and fastening instrument that includes an elongate channel that is attached to a handle assembly by an elongate shaft assembly. The elongate channel is configured to receive a cartridge and has a pivotally translatable anvil attached thereto and a knife bar supported therein. The anvil may be selectively opened and closed by manipulating a closure trigger supported by the handle assembly. The knife bar may be distally advanced through the elongate channel by actuating a firing trigger that cooperates with a reversible rotary drive supported by the handle assembly. The knife bar may also be retracted to its starting position by actuating the firing trigger after the reversible rotary drive has been shifted to a retraction orientation.

A sterile solution product bag for lyophilizing includes a bladder, a first stem having a first stem inlet end and a first stem outlet end. The first stem outlet end is fluidly connected to the bladder and the first stem inlet end is adapted to receive a liquid. A first filter is disposed in-line with the first stem and includes a first filter membrane, a first filter open end, and a first filter closed end. The first filter closed end is disposed between the first stem inlet end and the first stem outlet end and the first filter open end is disposed in proximity to the first stem inlet end. A second stem having a second stem inlet end fluidly connected to the bladder and a second stem outlet end adapted to receive a vapor. A second filter is disposed within the second stem and includes a filter membrane.