Description

The BD PhaSeal™ Assembly Feature is an integral component of the BD PhaSeal™ Closed System Drug-Transfer Device (CSTD) system, developed by Becton, Dickinson and Company (BD). This advanced system is designed to safeguard healthcare workers and the environment from exposure to hazardous drugs during the handling of parenteral medications, such as cytotoxic and antineoplastic agents.

Key Features

• Leakproof and Airtight: The system employs a closed, leakproof, and airtight design to prevent environmental contaminants from entering and hazardous drug vapors, aerosols, or spills from escaping.
• Membrane-to-Membrane Technology: Utilizes double membrane seals to maintain a secure barrier throughout drug preparation and administration.
• Ergonomic Assembly Fixture (M12): Facilitates the attachment of vial access devices, known as Protectors, to drug vials with ease and consistency.

Ease of Use

• One-Step Connection: Features a straight-push mechanism that simplifies the connection process, eliminating the need for alignment or orientation.
• Ergonomic Design: Supports a power grip and straight motion for connecting and disconnecting, aligning with NIOSH recommendations for user comfort and safety.

Compatibility and Sterility

• Versatile Compatibility: Compatible with standard-size drug vials, ISO-compliant syringes, IV sets, luer fittings, and tubing.
• Maintains Sterility: Engineered to prevent microbial ingress, maintaining drug vial sterility for up to 168 hours and 10 penetrations in ISO Class 5 environments with proper aseptic technique.

Safety and Material Specifications

• Single-Use Components: All components are intended for single patient use and should be disposed of without disassembly.
• Material Safety: Components are sterile, latex-free, DEHP-free, and BPA-free, ensuring safe use in medical environments.

Comprehensive System Components

• Protectors and Injectors: Includes vial access devices and syringe safety devices for secure drug transfer.
• Connectors and Adapters: Provides connectors for linking syringes, IV lines, and other system components, along with infusion adapters and clamps.

Procedures and Applications

• Secure Connections: Enables safe drug transfer and reconstitution between vials, syringes, and IV bags through snap-together connections.
• Versatile Administration: Supports various administration methods, including IV infusion, IV push, and intramuscular injections.

Environmental and Personnel Safety

• Reduces Contamination: Significantly lowers environmental contamination compared to open systems, protecting healthcare personnel.
• Training and Maintenance: Proper training is recommended for effective use, and cleaning with 70% sterile isopropyl alcohol is advised before use.

Limitations

• Vial Compatibility: Not suitable for all vial types, such as wide-neck vials and ampoules, and requires adherence to aseptic techniques and facility protocols for optimal performance.