The present technology is directed to an apparatus for freeze-drying various items. The apparatus described herein includes a reusable sealable container enabling aseptic handling of bulk processed materials. The multi-use tray enables a sterile sealable enclosure for use throughout the freeze-drying process, including: pre-freeze-drying (e.g., filling, handling, storage, transfer), freeze-drying processing, and/or post-freeze-drying (e.g., handling and storage).

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 filling valve may include a shuttle and a drive sleeve that are magnetically coupled. Movement of the drive sleeve may move the shuttle from a position in which the filling valve is closed to a position in which the filling valve is open. A container handling arm may include a distal end configured to hold a container and a proximal end that includes a load cell. A low flow setpoint system may be configured to arrest closing of a filling valve when that filling valve is partially closed. A pressure control system may be configured to maintain a desired pressure in a reservoir or in a flow path from that reservoir. A product recirculation system may be configured to adjust flow rate in the product recirculation system.

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.

Described and illustrated is a method to sterilise containers or receiving flowable foods; in a filling device. The method includes evaporating a hydrogen peroxide solution in an evaporator impinging at least one container with the vaporous hydrogen peroxide in a sterilisation zone and at least partially removing the unconsumed part of the vaporous hydrogen peroxide from the sterilisation zone. The removed vaporous hydrogen peroxide is at least partially condensed in a condenser and the condensed hydrogen peroxide is supplied to the evaporator.

A filling device for aseptic filling of pouches comprising a pouch fill assembly having a movement assembly, a plug removing assembly and a filling assembly. The movement assembly defining an aseptic zone and configured to direct a pouch having a spout and a plug sealing the spout through the pouch fill assembly from an inlet to an outlet. The plug removing assembly having at least one plug removing station including a grasping assembly, a plug retaining structure and an actuator assembly. The filling assembly having at least one filling station structurally configured to dispense a flowable material into the pouch through the spout.

An automated, unmanned continuous system (200) for packaging flowable food products at elevated temperatures and pressures includes an upstream thermal processing station (202) to heat the food products and direct the heated food products to a pressurized unmanned filling station (204), whereat containers (242) are filled with the heated food products within a pressurized housing (232), and then transported to a pressurized and unmanned sealing station (206) where the containers are sealed with a lid or cover (283) within a pressurized housing (282). Thereafter, the filled and sealed containers (242) are routed from the pressurized housing (282) through a pressurized transfer tube or passageway (208) for further processing at a downstream thermal processing station (210).

A hazardous drug deactivation wipe kit includes a first pouch having a one-way valve coupled to an end thereof, a second pouch, and a third pouch. The first pouch contains a wipe saturated in a hypochlorite solution, the second pouch contains a wipe saturated in thiosulfate solution, and the third pouch contains a wipe saturated in isopropyl alcohol solution. The deactivation wipe kit may be used in a clean room to deactivate most hazardous drugs on a work surface.

A food processing and/or packaging device comprises at least one food chamber. Via a conduit system, the at least one food chamber is connected to a vacuum pump for generating vacuum in the at least one food chamber. For sterilizing the conduit system and/or the food chamber, a sterilization device is provided. The sterilization device comprises e.g. spray nozzles for introducing cleaning liquid into the conduit system. The cleaning liquid is separated by a liquid separator arranged upstream of the vacuum pump in flow direction.