Decontamination system for use with a rapid transfer port
This invention relates to the decontamination of transfer containers for use with rapid transfer port (RTP) systems, which are used to transfer articles between two environments, such as an isolator barrier system and a transfer container, that are adapted to be brought into close proximity to one another by a docking operation. Traditionally, the container must be sterilized, usually by using a steam or vapor hydrogen peroxide (VHP) bactericide, prior to docking. The sterilization process can be lengthy and inefficient, particularly in manufacturing operations that require a continuous flow of decontaminated RTP canisters. This invention allows the user to decontaminate the RTP canister without impacting the usage requirements of either the autoclave or the isolator system. Its modular design is such that multiple decontamination units can be connected to a single VHP gas generator, as required by the manufacturing flow.
The system includes an enclosure (A) for providing a closed volume for bactericide vapor. The enclosure has a container access opening (B) for providing vapor communication between a container (C) and the closed volume. A container interface assembly (D) positions, locks and seals the container to the enclosure. A container door removal system (E) is partially contained within the enclosure and is operably engaged with the enclosure and attachable to the container door (F). The container door removal system includes an actuator element (G) located outside of the enclosure. A vapor injection system has an inlet (H) and an outlet (I) for the bactericide vapor. A mixing fan (J) is angled to maximize mixing of bactericide vapor within the enclosure.
During operation, a container is attached to the container interface assembly and the container door is separated from the container by operating the actuator element of the container door removal system, providing vapor communication between the closed volume and the volume within the container. The bactericide vapor may be introduced into the enclosure and the container via the vapor injection system.
Although this invention is intended for use in the pharmaceutical industry, it is equally applicable to the medical device industry and any other industry requiring the decontamination of a container with bactericide vapor.
Patent number: 6,969,497
Date: November 29, 2005
Inventor: Giuseppe Sacca, Laguna Niguel, Calif.
Automatic microbial air sampling system and method
This invention describes an automatic air sampling system that is useful for remotely sampling air from an isolated container-filling machine to assess the possibility of microbial contamination. Traditionally, to test for microbial contamination, a technician manually passes an agar-filled petri dish or settling jar into an isolator through sterile transfer ports. The technician then opens the dish through the gloved ports and times its exposure within the isolator. He then covers the dish through the gloved ports, removes it from the isolator through the sterile transfer ports, and transports the dish to an incubator for growth promotion. This cumbersome task may be performed repeatedly each day and great care must be taken to avoid disturbing the normal airflow patterns inside the isolator if representative results are to be expected. This invention, however, purports to provide a convenient method and means for collecting a gas sample from within an isolator, then remotely and automatically exposing it to media in a sample container outside the isolator so as to test the gas sample for microbial growth.
An enclosure (A) is positioned outside an isolator, which typically encloses an aseptic filling machine or other process equipment that requires especially clean or sterile conditions inside the isolator. An infeed sample receiver (B) passes gel-media-containing sample containers (C) into the enclosure. An atrium (D) is located within the enclosure and exposes containers to a gas sample. A remote sampling device (not shown) receives the gas sample from the isolator and passes it to the atrium. A load arm (E) intermittently permits containers to enter the enclosure and moves containers to the atrium. An outfeed sample receiver (F) passes containers out of the enclosure. A user can utilize the infeed and outfeed sample receivers to supply and remove containers to and from the air sampling system without interrupting the processing of the container within the enclosure. The system is designed to allow the first container supplied to the air sampling system to be the first exposed container removed.
Patent number: 6,958,234
Date: October 25, 2005
Inventor: Alan H. Aicher, Bristol, Wis.