Horizontal integrated autoclave with automated sliding door
The autoclave can be integrated in grade C / ISO 7 hot cells and in grade A / ISO 5 isolators. It is typically used for terminal sterilization of products which, because of that, do not require an aseptic environment. It could however add flexibility in a production line having an isolator that can do both aseptic production as well as products that require terminal sterilization.
The autoclave can be integrated in grade C / ISO 7 hot cells and in grade A / ISO 5 isolators. It is typically used for terminal sterilization of products which, because of that, do not require an aseptic environment. It could however add flexibility in a production line having an isolator that can do both aseptic production as well as products that require terminal sterilization.
There are multiple challenges when integrating an autoclave in a hot cell. The pressure chamber needs to be shielded to protect the area around it, but also any component that could become radioactive in case of a damaged vial needs to be within this same shielded environment. This means that we need to use local heat exchangers, condensate tank and other measures to make sure the system remains safe in all situations. Automatic leak testing is done at the beginning of each cycle as a risk-mitigation action. Keeping everything well accessible for service and calibration, while minimizing the foot print in the technical area is also a key-part of the design.
Because of natural decay of the products used it is vital that the cycle is kept as short as possible, for which reason we use powerful steam generators and cooling units. To ensure keeping the vials intact during this rapid cooling step at the end of the cycle, the chamber pressure decreases corresponding to the product temperature.The chamber can contain up two 80 vials, depending on the vial size. These are loaded on trays which can be done with ball-tongs or with manipulator arms. The software and reporting is GAMP and GMP compliant.
Please contact sales@vongahlen.com if you would like to receive more information about the autoclave or press the button below to discover the Hot cell GMP and Hot cell USP where the autoclave can be integrated.
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