Ansamed can provide test data at various stages of the process to support your requirements. Full process and product validations can be completed on behalf of the customer. Where possible automated measuring systems are utilised to provide maximum confidence in the ability of the process to produce product which consistently meets specifications.

Our testing procedures use state of the art equipment validated on site providing the following test capability:

Dimensional Assessment:

• Ultrasonic Wall Thickness with Laser Gauge Dual Axis System
• (allowing inline measurement of concentricity, ID, OD, wall thickness, layer thickness and ovality.)
• Video Measurement System up to 360x magnification,
• Lasermicrometers
• Shadow graphs

Mechanical Assessment:

• Burst pressure testing
• Tensile testing
• Compression testing
• Stiffness testing
• Leak testing
• Torque testing
• Flow rate testing

All mechanical testing can be completed in water at 37 degress Celsius simulating clinical conditions.

Materials Characterisation:

• Melt flow testing
• Material moisture analysis
• DSC*
• SEM*
• IR*

*Completed in conjunction with laboratory partners.

Additional testing:

Aging Studies (Temperature and moisture controlled environmental aging chamber)

Product performance evaluation

(using clinically simulated tracks designed in conjunction with customer).

• Biocompatibility*
• Sterility*
• LAL*

*Completed in conjunction with laboratory partners.