The Non-Rotating Canister (NRC) is a RTP canister system featuring a proprietary NR flange that permits rotation of the Beta flange relative to the canister body.
The NRC is designed to interface with any industry standard RTP ports.
The NRC canister must be either VHP decontaminated or steam sterilized prior to its use for aseptic transfers. Following are some notes regarding the two processes.
Steam Sterilization Process
The NRC canister, with the beta door removed, is placed on a cart inside an autoclave. The autoclave must have an autoclave interface isolator. After the sterilization cycle, the NRC canister is transferred into the autoclave interface isolator where the operator installs the beta door via gloves. The sealed NRC canister is then transferred back through the autoclave and out to the manufacturing facility. It is now ready to use because its internal surfaces have been sterilized.
Steam sterilization may also be accomplished by permitting steam to enter the canister via an absolute filter port located on the canister body itself.
VHP Gas Decontamination Process
The NRC canister is decontaminated by docking it to the Alpha port of a transfer isolator, opening the RTP door and running a VHP decontamination cycle of the isolator itself.
The NRC canister is placed inside a transfer isolator with the beta door removed and a VHP cycle run. At the end of the cycle, the operator installs the beta door onto the NRC via gloves and then the NRC is removed from the isolator
The NRC canister is connected to a DECON unit manufactured by Dynamic Design Pharma, Inc. and the VHP cycle is run to decontaminate the canister. This process does not affect the aseptic manufacturing flow. This off-line process permits rapid decontamination of the canister using a standard VHP generator.