A packaging machine configured to form, fill, and seal individual packages is provided. The packaging machine includes a disinfection/sterilization station configured to treat ready-to-fill packaging containers passing through said disinfection station. The disinfection/sterilization station includes a supply section configured to provide gaseous sterilizing agent into open ends of the ready-to-fill packaging containers passing the supply section, and a holding section arranged downstream the supply section. The packaging machine is configured to keep the ready-to-fill packaging containers at the supply section such that the sterilizing agent will condense on areas of the ready-to-fill packaging container having a temperature below the dew point of the sterilizing agent, and the packaging machine is configured to keep the ready-to-fill packaging containers at the holding section such that the gaseous sterilizing agent will treat areas of the ready-to-fill packaging container having a temperature above the dew point of the sterilizing agent.

A packaging machine configured to form, fill, and seal individual packages is provided. The packaging machine includes a disinfection/sterilization station configured to treat ready-to-fill packaging containers passing through said disinfection station. The disinfection/sterilization station includes a supply section configured to provide gaseous sterilizing agent into open ends of the ready-to-fill packaging containers passing the supply section, and a holding section arranged downstream the supply section. The packaging machine is configured to keep the ready-to-fill packaging containers at the supply section such that the sterilizing agent will condense on areas of the ready-to-fill packaging container having a temperature below the dew point of the sterilizing agent, and the packaging machine is configured to keep the ready-to-fill packaging containers at the holding section such that the gaseous sterilizing agent will treat areas of the ready-to-fill packaging container having a temperature above the dew point of the sterilizing agent.

A sterilization method includes a circulation step of circulating a sterilizer through a circulation line (53) while the sterilizer is being heated by a heater (H), and a sterilization step of sterilizing a filling chamber (42) by supplying, to the filling chamber (42), the sterilizer heated by the heater (H).

A sterilization method includes a circulation step of circulating a sterilizer through a circulation line (53) while the sterilizer is being heated by a heater (H), and a sterilization step of sterilizing a filling chamber (42) by supplying, to the filling chamber (42), the sterilizer heated by the heater (H).

The present disclosure provides novel processes for providing sterile, pre-filled syringes or injection devices for pharmaceutical compositions, including protein and biopharmaceutical formulations. In some examples, secondary packaging is performed in an aseptic environment, which removes the need for any terminal sterilization method. In some examples, the aseptic packaging method results in a sterile injection device suitable for use in ophthalmic injections.

A container manufacturing plant (10) includes an air circuit (78) employing a recycling method that includes at least the successive steps of: extracting filtered air from an oven (26), after the air has been used in the latter, for the purpose of cooling at least one part of the preforms; treating the sterilizing agent present in the extracted air resulting from the sterilization of the preforms; and recycling the extracted and treated air to the industrial area (16) where the plant (10) is installed. An air recycling method is also described.

A closure for a pharmaceutical vial. The closure comprises an aluminum foil with an inductively meltable adhesive, an elastic seal, and a cap. The cap has an opening through which a perforating cannula can be inserted.

A closure for a pharmaceutical vial. The closure comprises an aluminum foil with an inductively meltable adhesive, an elastic seal, and a cap. The cap has an opening through which a perforating cannula can be inserted.

Provided is a novel container sterilization method in which no liquid agent is used. A container sterilization method is a method of performing sterilization by supplying a sterilization component to a container that is continuously conveyed along a predetermined conveyance path, the container sterilization method including supplying a humid ozone gas to a sterilization area, the humid ozone gas being an ozone gas that has humidity, the sterilization area being partitioned by a sterilization chamber that contains the conveyance path. It is preferable that the humid ozone gas to be supplied to the sterilization area have a higher temperature than the container to be conveyed to the sterilization area and the sterilization chamber have a higher temperature than the container to be conveyed to the sterilization area.

A method of sterilizing a prefilled syringe comprises assembling a syringe assembly and performing at least one ethylene oxide (EtO) sterilization procedure cycle. The assembling step includes inserting a tip cap at a first end of a plunger, filling a non-glass barrel with sterilization sensitive material at a second end of the barrel, and inserting the plunger into the barrel at a second end to seal the sterilization sensitive material within the barrel. The EtO sterilization procedure cycle comprises undergoing a preprocessing stage, a wash and conditioning stage, an EtO sterilization stage and a wash and post exposure stage. Upon completing the EtO sterilization procedure cycle, a resultant pH of the sterilization-sensitive material does not exceed an acceptable pH range as defined by the United States Pharmacopeia. The disclosure also discusses inserting an assembled prefilled syringe into a procedure tray prior to performing the EtO sterilization procedure cycle.