Alpha XT

System Description

The Alpha XT system is a proprietary Alpha port that allows docking the beta flange and opening the alpha door without the gloved entry of the operator into the isolator chamber.

Features

• Operation solely from the non-sterile (operator) side
• Optional funnel actuator to engage/disengage a funnel into component delivery position
• Adaptable to any alpha port manufacturer
• Minor modifications to the alpha port with no impact on the port’s door interlock functionality
• Separate actuators for the door locking, door opening and funnel positioning functions
• Positive position lock of the alpha door in the open position
• Positive position lock of the funnel in the engaged and the disengaged positions
• Clean aseptic zone design compatible with wash down operations and VHP decontamination
• Leak tight construction
• Modular design is easily incorporated in new isolator systems or retrofitted into existing installations

Specifications

• Nominal port size: 190mm, 270mm, 350mm, 460mm
• Adaptable to any industry standard alpha port
• Alpha/Beta door interlock functionality: unaffected
• Alpha door positive lock in the open position
• Alpha door rotation: 90 degrees
• Funnel rotation: 90 degrees
• Configurable for right hand and left hand operation
• 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.
• Funnel configuration: As required by the application
• Material: 316L Stainless Steel
• Surface Roughness: 0.89 micrometers (35 microinches)
• Surface Treatment: Electropolished

Advantages & Applications

Alpha XT Advantages

• All docking operation a are conducted from the operator side of the isolator
• Manipulation of the delivery funnel is conducted from the operator side of the isolator
• Funnel is precisely positioned concentric to the alpha port inside diameter

Alpha XT Applications

• Transfer of sterile components from a BetaBag directly into the vibratory bowl of the filling line without the operator entering the isolator chamber.
• Transfer of sterile components from a tank directly into the vibratory bowl of the filling line without the operator entering the isolator chamber. See Beta NR-HP system for details.
• Transfer of sterile components through the bulkhead of a class 100 suite.

Beta NR-HP Application

• The Alpha XT permits docking a tank containing cleaned and sterilized stoppers and featuring a beta flange without operator entry into the isolator system. To facilitate the docking process, the tank could include DDP’s Beta NR-HP flange which, by virtue of its NR flange incorporating DDP’s proprietary NR Technology, permits rotation of the beta flange without rotation of the tank.

Retrofit of existing systems

• The Alpha XT’s modular design and flexibility in configuration make it conducive to retrofit of the component introduction system of existing filling lines to achieve the elimination of operator entry into the isolator chamber during transfer operations.

Documentation

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

Instruction Manual

• 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 Report
• Presentation
• Brochure