A system of managing the sterilisation of empty flexible pouches (1) provides applying sacrificial closures (200) to the empty pouches, loading the empty provisional closed pouches to be sterilised on a transport device (300) for the collective transportation, performing the sterilisation of the transport device (300) carrying the empty provisional closed pouches, and finally separating, in a sterile chamber, the sacrificial closures (200) from the pouches, filling and applying a tamper-proof cap (100).

Provided are a method and an apparatus for sterilizing a sleeve that can shorten a sterilization process for a paper container sleeve and ensure a sterilization effect. In a method for sterilizing a sleeve in an aseptic filling system that molds the sleeve into a paper container having a bottomed tubular shape by closing surfaces of an open end part of the sleeve and performs sterilization, filling and sealing of the paper container, the sleeve being a tubular body having walls formed by laminating at least paper, in a state where the sleeve stands in a columnar shape, heated air containing a sterilizer is blasted to an inner surface of the sleeve that is to form a bottom part of the paper container to perform sterilization of the inner surface of the bottom part and heating for the closing at the same time.

A sterilization apparatus for sterilizing a web of packaging material advancing along a web advancement path-comprises an irradiation device for sterilizing the advancing packaging material web, a main shielding chamber housing the irradiation device and comprising an advancement channel having an inlet opening and an outlet opening and through which, in use, the packaging material web advances along the sterilization portion, an auxiliary shielding chamber upstream of the advancement channel along the web advancement path, the auxiliary shielding chamber having an inner space in fluid connection with the advancement channel and comprising an extraction opening allowing gas extraction from the auxiliary shielding chamber. An aspiration device generates a first flow of gas within the advancement channel from the outlet opening to the inlet opening and a second flow of gas from the inlet opening to the extraction opening.

A sterilization apparatus for sterilizing a web of packaging material advancing along a web advancement path-comprises an irradiation device for sterilizing the advancing packaging material web, a main shielding chamber housing the irradiation device and comprising an advancement channel having an inlet opening and an outlet opening and through which, in use, the packaging material web advances along the sterilization portion, an auxiliary shielding chamber upstream of the advancement channel along the web advancement path, the auxiliary shielding chamber having an inner space in fluid connection with the advancement channel and comprising an extraction opening allowing gas extraction from the auxiliary shielding chamber. An aspiration device generates a first flow of gas within the advancement channel from the outlet opening to the inlet opening and a second flow of gas from the inlet opening to the extraction opening.

A packaging machine for producing sealed packages of a pourable product from a packaging material web advancing along a web advancement path comprises an isolation chamber separating inner and outer environments, and a sterilization apparatus for sterilizing the packaging material web and in fluid connection with the isolation chamber. The sterilization apparatus comprises a main shielding chamber housing an irradiation device and comprising an advancement channel having inlet and outlet openings, and through which, in use, the packaging material web advances, and first and second auxiliary shielding chambers having respectively first and second inner spaces fluidically connected to the advancement channel. A pressure control controls a first pressure in the first auxiliary shielding chamber, a second pressure in the second auxiliary shielding chamber and a third pressure in the isolation chamber, the third pressure being higher than the second pressure and the second pressure being higher than the first pressure.

A packaging machine for producing sealed packages of a pourable product from a packaging material web advancing along a web advancement path comprises an isolation chamber separating inner and outer environments, and a sterilization apparatus for sterilizing the packaging material web and in fluid connection with the isolation chamber. The sterilization apparatus comprises a main shielding chamber housing an irradiation device and comprising an advancement channel having inlet and outlet openings, and through which, in use, the packaging material web advances, and first and second auxiliary shielding chambers having respectively first and second inner spaces fluidically connected to the advancement channel. A pressure control controls a first pressure in the first auxiliary shielding chamber, a second pressure in the second auxiliary shielding chamber and a third pressure in the isolation chamber, the third pressure being higher than the second pressure and the second pressure being higher than the first pressure.

An injector may include a container having a wall with an interior surface and a seal assembly with an interior surface, the interior surfaces of the wall and the seal assembly defining a closed sterile reservoir filled with a drug product. The injector may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle having a point disposed only partially through the seal assembly in a storage state, and disposed through the interior surface of the seal assembly into the sterile reservoir in a delivery state. Further, the injection may include an actuator that is adapted to move the container needle from the storage state to the delivery state.

An injector may include a container having a wall with an interior surface and a seal assembly with an interior surface, the interior surfaces of the wall and the seal assembly defining a closed sterile reservoir filled with a drug product. The injector may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle having a point disposed only partially through the seal assembly in a storage state, and disposed through the interior surface of the seal assembly into the sterile reservoir in a delivery state. Further, the injection may include an actuator that is adapted to move the container needle from the storage state to the delivery state.

A preform is sterilized by a preform sterilizer. The preform is blow-molded by a blow-molding device to manufacture a container. Next, the container is filled with a culture medium by a filling device without sterilizing the container by a container sterilizer, and the container is plugged by a plugging device. Thereafter, it is verified how much microorganism survive or propagate in the culture medium in the container. A degree of sterilization in the container sterilizer is adjusted on the basis of a verification result.

An injector may include a container having a wall with an interior surface and a seal assembly with an interior surface, the interior surfaces of the wall and the seal assembly defining a closed sterile reservoir filled with a drug product. The injector may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle having a point disposed only partially through the seal assembly in a storage state, and disposed through the interior surface of the seal assembly into the sterile reservoir in a delivery state. Further, the injection may include an actuator that is adapted to move the container needle from the storage state to the delivery state.