Custom tube assembly

Description
Gamma-irradiated single-use assemblies designed for biopharmaceutical manufacturing. Assemblies range from simple tubing with connector to complex manifold assemblies with multiple connections. Components are manufactured and assembled under controlled clean-room conditions: assemblies are manufactured and packed in Class 7 certified clean rooms, while critical components are assembled in Class 5 certified clean rooms. The majority of key components are produced in-house to support traceability and process control.

Applications

• Upstream processing in biopharmaceutical production
• Downstream processing in biopharmaceutical production
• Cell culture processing
• Fill-finish operations
• Aseptic fluid transfer

Certifications

• Compliant with FDA 21 CFR 177.2600
• Laboratory test certificate
• TSE/BSE-free certificate
• Phthalate-free certificate

Key Features

• Gamma irradiation sterilization
• Customizable assemblies to specification
• Diameter capability from 100 mm
• In-house manufacturing of key components
• Manufactured in Class 7; critical assembly in Class 5 clean rooms

Technical specifications

• Product type: Gamma-irradiated single-use assemblies
• Range: From simple tubing with connector to complex manifold assemblies with multiple connections
• Manufacturing environment: Assemblies manufactured and packed in Class 7 certified clean rooms
• Critical assembly environment: Critical components assembled in Class 5 certified clean rooms
• Components: Majority of key components manufactured in-house
• Regulatory compliance: Compliant with FDA 21 CFR 177.2600
• Certificates: Laboratory test certificate; TSE/BSE-free; Phthalate-free
• Typical applications: Upstream processing, downstream processing, cell culture processing, fill-finish, aseptic fluid transfer
• Customization: Available to meet specific assembly and dimensional requirements
• Diameter capability: From 100 mm