Description

The EQUASHIELD Reconstitution Set is an integral component of the EQUASHIELD Closed System Transfer Device (CSTD) System, specifically engineered to enhance safety in the handling of hazardous drugs. This advanced medical device is designed for use by licensed pharmacists and healthcare professionals in hospitals and clinics, ensuring secure preparation, reconstitution, compounding, and administration of drugs, including antineoplastic agents.

Key Features

• Closed System Design: The set effectively minimizes exposure to drug vapors, aerosols, and spills, safeguarding both individuals and the environment. It achieves this by mechanically preventing the ingress of environmental contaminants and the egress of drug vapors.

• Microbial Barrier: The system prevents microbial ingress for up to seven days, maintaining a sterile environment. This is achieved through a double-membrane method that ensures leak-proof connections and prevents drug residue.

• Airtight Encapsulation: The Syringe Unit is fully encapsulated and features a leak-proof connector, integrated with a built-in pressure equalization system. This design includes a variable sterile air chamber, enhancing the device's airtight sealing capabilities.

System Components

The Reconstitution Set includes various components such as:

• Syringe Unit
• Vial A adaptor
• Spike A adaptors
• Luer Lock adaptors
• Protective Plug

These components facilitate secure drug transfer and reconstitution, ensuring compatibility with IV lines and drug vials.

Material Composition

The materials in the drug path include:

• Polypropylene
• PVC
• Silicone
• Stainless Steel
• Polyoxymethylene (POM)
• ABS
• Polyisoprene

A hydrophobic filter is also incorporated to enhance safety and functionality.

Sterilization and Shelf Life

The device is sterilized using ethylene oxide (EO) with a sterility assurance level of 10^-6, and it boasts a shelf life of three years. Extensive testing confirms compliance with relevant ISO, USP, and ASTM standards, ensuring the device's reliability and effectiveness.

Testing and Compliance

The EQUASHIELD Reconstitution Set has undergone rigorous non-clinical testing, including biocompatibility, sterility, and packaging assessments. These tests validate its ability to prevent microbial ingress, maintain drug stability, and ensure mechanical integrity, even after aging and transport.

This comprehensive design and testing framework positions the EQUASHIELD Reconstitution Set as a critical tool in the safe handling of hazardous drugs, providing healthcare professionals with confidence and peace of mind in their daily operations.