A process line for the production of freeze-dried particles under closed conditions is provided, the process line comprising a freeze-dryer for the bulkware production of freeze-dried particles under closed conditions, the freeze-dryer comprising a rotary drum for receiving the frozen particles, and a stationary vacuum chamber housing the rotary drum, wherein for the production of the particles under closed conditions the vacuum chamber is adapted for closed operation during processing of the particles; the drum is in open communication with the vacuum chamber; and at least one transfer section is provided for a product transfer between a separate device of the process line and the freeze-dryer, the freeze-dryer and the transfer section being separately adapted for closed operation, wherein the transfer section comprises a temperature-controllable inner wall surface.

A process line for the production of freeze-dried particles under closed conditions is provided, the process line comprising a freeze-dryer for the bulkware production of freeze-dried particles under closed conditions, the freeze-dryer comprising a rotary drum for receiving the frozen particles, and a stationary vacuum chamber housing the rotary drum, wherein for the production of the particles under closed conditions the vacuum chamber is adapted for closed operation during processing of the particles; the drum is in open communication with the vacuum chamber; and at least one transfer section is provided for a product transfer between a separate device of the process line and the freeze-dryer, the freeze-dryer and the transfer section being separately adapted for closed operation, wherein the transfer section comprises a temperature-controllable inner wall surface.

A vial stopper for closure of a lyophilization vial is disclosed. The vial stopper has a stopper body comprising a first circumferential sealing surface for hermetically sealing against an interior surface of a mouth of the vial in a first position of the vial stopper. The stopper body further comprises a second circumferential sealing surface for hermetically sealing against the interior surface of the mouth of the vial in a second position of the vial stopper. The second sealing surface is spaced apart from the first sealing surface in an axial direction of the stopper body. The stopper body further comprises an intermediate region in between the first and second sealing surfaces, the intermediate region having at least one venting element for venting an interior of the vial in at least one intermediate position of the stopper in between the first and second positions.

A vial stopper for closure of a lyophilization vial is disclosed. The vial stopper has a stopper body comprising a first circumferential sealing surface for hermetically sealing against an interior surface of a mouth of the vial in a first position of the vial stopper. The stopper body further comprises a second circumferential sealing surface for hermetically sealing against the interior surface of the mouth of the vial in a second position of the vial stopper. The second sealing surface is spaced apart from the first sealing surface in an axial direction of the stopper body. The stopper body further comprises an intermediate region in between the first and second sealing surfaces, the intermediate region having at least one venting element for venting an interior of the vial in at least one intermediate position of the stopper in between the first and second positions.

An arrangement for monitoring an aseptic manufacturing process includes product condition sensors capable of making closely spaced measurements of a product condition such as temperature or humidity. The measurements are made using closely spaced sensors arranged in a linear array on a single probe, which may be used to take measurements at multiple levels within the product. Data from the sensors is transmitted to a data collection point via short range wireless digital communications. The sensors may be used to measure temperature and humidity at a single point. For example, when the sensors are used in pharmaceutical freeze drying, the location of a sublimation front may be calculated for each vial, and the freeze drying process may be controlled using the data.

An arrangement for monitoring an aseptic manufacturing process includes product condition sensors capable of making closely spaced measurements of a product condition such as temperature or humidity. The measurements are made using closely spaced sensors arranged in a linear array on a single probe, which may be used to take measurements at multiple levels within the product. Data from the sensors is transmitted to a data collection point via short range wireless digital communications. The sensors may be used to measure temperature and humidity at a single point. For example, when the sensors are used in pharmaceutical freeze drying, the location of a sublimation front may be calculated for each vial, and the freeze drying process may be controlled using the data.

A compact freeze dryer removes a liquid from a bulk powder product. The freeze dryer utilizes a single cryogenic vessel for both (1) freezing the liquid contained in the bulk product, and (2) condensing vapor resulting from sublimating the frozen liquid. A vacuum pump is connected to the cryogenic vessel for drawing a vacuum in the cryogenic vessel and in a drying vessel. Vapor resulting from subliming the frozen liquid in the drying vessel is drawn into the cryogenic vessel and condensed.

A carrier plate for inserting containers filled with a medical, pharmaceutical or cosmetic substance into a freeze dryer, wherein the carrier plate comprises a plurality of receptacles that are configured to each receive a container. Furthermore, the present application relates to a carrier plate arrangement having a plurality of such carrier plates. Furthermore, the present application relates to a loading system for a freeze dryer, wherein the loading system comprises one or more handling devices and one or more such carrier plates or the carrier plate arrangement. Furthermore, the present application relates to a loading system and to a freeze-drying system having such a loading system.

A carrier plate for inserting containers filled with a medical, pharmaceutical or cosmetic substance into a freeze dryer, wherein the carrier plate comprises a plurality of receptacles that are configured to each receive a container. Furthermore, the present application relates to a carrier plate arrangement having a plurality of such carrier plates. Furthermore, the present application relates to a loading system for a freeze dryer, wherein the loading system comprises one or more handling devices and one or more such carrier plates or the carrier plate arrangement. Furthermore, the present application relates to a loading system and to a freeze-drying system having such a loading system.

Provided is a gas fill fixture for use in lyophilization, a related system and method. The gas fill fixture includes a chassis, fill indicator and a lid, such that the chassis and lid together form a cavity for receiving a flexible lyophilization container. The system includes a lyophilization container, a lyophilizer and a gas fill fixture incorporating a chassis, a fill indicator and a lid. The method includes process steps for using the system to lyophilize a fluid.