US Patent No. 6,655,759

NRC Canister

The RTP Canister for the more challenging applications

The beta flange is free to rotate relative to the canister body
Incorporates DDP's proprietary NR Technology
Nominal beta sizes: 190mm, 270mm, 350mm & 460mm
Compatible with La Calhene's and CRL's RTP ports
Canister body can be customized to the application
Shuttle and tray compatible with VHP and Steam
Material handling interface features
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System
Features
Specifications
Advantages & Applications
Sterilization
Documentation
Photo Gallery

System Description

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 industry standard RTP ports, including Getinge-La Calhene and CRL RTP ports.

Features

Beta flange integrated into the NR Flange or bolted to the NR flange
Proprietary NR flange consisting of bearing system and dynamic seal - see NR Technology
Aluminum or Stainless steel construction, per customer requirements
Material handling system interface features
Lifting handles along canister body
Docking handles connected to NR flange
Internal shuttle for tray movement, in two configurations: VHP model or Steam Model
Internal tray, custom designed to the application or in its standard form. Attaches to the shuttle with quick disconnectmeans or permanent fasteners.

Specifications

Nominal beta flange size: 190mm, 270mm, 350mm, 460mm
Length of standard canister body: As required by the application
Material: 6061-T6 aluminum alloy or 316 stainless steel
Shuttle stroke from retracted to extended position: As required by the application
Leak tight: Ammonia leak test at 250 pascal internal pressure.
Steam sterilization compatible (with beta door removed)
VHP decontamination compatible

Advantages & Applications

NRC Canister Advantages

The NRC Canister technology facilitates applications that are difficult to implement with standard RTP canister docking process requiring beta flange rotation relative to the alpha flange

The shuttle and tray hardware permit the safe transfer of heavy or delicate parts into and out of isolator system.
Material handling features and self supporting devices on the canister body that make its transport and docking safe for the operator.
Customization of the canister body geometry and internal tray to the application.

NRC Canister Applications

Production materials introduction: API, Stoppers
Sterile part introduction during machine set up
Sterile components introduction and removal during the production campaign
Production Support Supplies: Micro supplies, cleaning supplies, tools.
Product transfers into/out of the isolator chamber

Sterilization/Decontamination of the NRC Canister

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.