Alpha NR / NRF

System Description

The Alpha NR system is an alpha flange that is configured to dock to a stationary (not rotating) beta flange, such as one found on a stopper tank or a transfer isolator.

The Alpha NR incorporates Dynamic Design Pharma’s NR Technology that permits the leak tight rotation of the alpha flange relative to its mount. The Alpha NRF can be built with an optional pressure release system.

The Alpha NRF flange is identical to the Alpha NR flange except the NRF flange floats in all planes to facilitate the docking process.

Features

• The Alpha NR is fixed to the isolator wall (no float) for those applications where the beta flange includes some amount of free play (float) or secondary alignment means are included to precisely align the beta and the alpha sides of the RTP port.
• The Alpha NRF is mounted on a silicone rubber diaphragm that provides a +/- 10mm float in all planes during docking to a fixed beta flange.
• The Alpha NR/NRF Flange is adaptable to all sizes and alpha port manufacturers.
• Alpha flange port is mounted onto a NR flange that is based on DDP’s proprietary NR Technology.
• Handles attached to the NR flange to rotate the alpha port during the docking process.
• Anti-rotation features lock the beta flange in position to assure correct orientation during docking
• Clean aseptic zone design compatible with wash down operations and VHP decontamination
• Leak tight construction
• Modular design is easily incorporated in to new isolator systems or retrofitted into existing installations

Specifications

• Nominal beta flange size: 190mm, 270mm, 350mm
• Adaptable to any industry standard alpha ports
• Alpha/Beta door interlock functionality unaffected
• Beta flange anti rotation: device provided that engages a feature on the alpha flange to prevent beta flange rotation during docking
• Alpha NRF flange float: +/- 10mm (Alpha NRF only)
• NR Flange construction: 316L stainless steel structure with internal ball bearing system and dynamic seal.
• Materials: 316L Stainless steel, silicone, Teflon
• Orientation: Operable from vertical to 45 degree inclination
• Compatible with wash down operations
• Compatible with VHP decontamination
• Leak tight: Ammonia leak test at 250 pascal internal pressure.

Advantages & Applications

Alpha NR and Alpha NRF Applications

• Transfer of sterile components, such as stoppers, from a tank to the filling machine.
• Transfer of sterile components between two isolators, for example between a transfer isolator and a filling isolator.
• Transfer of sterile components from a transfer isolator to the bulkhead of a class 100 suite.

Beta flange configuration

• The beta flange simply includes an interface adapter, for example a triclover flange adapter, to facilitate the attachment to the system to be docked to the alpha flange.

Documentation

Each system is shipped with a document which includes the following sections:

• Installation instructions
• Operation instructions
• Maintenance instruction (preventive and corrective)
• Recommended spare parts
• Assembly drawings

Validation Support

• Material certification
• Surface treatment certification
• Leak test certification

Reference Documentation

• Press Release
• Leak Test Reports