Medical Devices - Surface Analysis Services by CERAM for the Medical Device Industry

Topics Covered

Background
     Benefits to Customer
Case Studies
     Analysis of Sterilisation Techniques used on Medical Tubing
     Coating Characterisation of Medical Sensors
     Investigation into the Leakage of a Metered Dose Inhaler
     Analysis to Determine Distribution of a Drug on a Coated Stent

Background

Surfaces of medical devices are of critical importance as they control many clinical properties including the immediate response from the biological host.

The medical device industry is using surface analysis techniques on a day to day basis in the testing sequence for both regular manufacturing QC protocols and in new product development.

CERAM offers a range of analytical techniques which can benefit the medical device industry including:

Benefits to Customer

XPS, Imaging ToFSIMS and DSIMS depth profiling have been used to provide information on medical devices, including catheters, blood contact devices including filters and vascular grafts, contact and intra-ocular lenses, inhaler cans and stents.

Some of the applications of surface analysis include:

  • Coating conformation and integrity determination
  • Contamination analysis and quantification
  • Monitoring molecular diffusion and protein and cell adsorption
  • Auditing medical device production

Companies are using bodies of surface analysis data in conjunction with other test results to demonstrate product quality and compliance to their appropriate regulatory authorities in medical device technologies.

Case Studies

Four case studies are detailed below showing the types of analysis available at CERAM.

Analysis of Sterilisation Techniques used on Medical Tubing

A combination of XPS and SIMS was utilised to assess different sterilisation procedures used for sterilising plasticised PVC tubing for blood contact applications.

A series of tubes, which had undergone different sterilisation processes, were analysed to determine the surface coverage of DEHA/DEHP.

AZoM - Metals, ceramics, polymers and composites - Plasticiser surface concentration on the surface of PVC.

Figure 1. Plasticiser surface concentration on the surface of PVC.

The results allowed the client to determine the best sterilisation procedure for the PVC tubing.

Coating Characterisation of Medical Sensors

Imaging SIMS has been used to characterise the coating and determine the surface coverage of a plasma pre-treated coated mesh used in medical sensors. Imaging SIMS provided a direct indication of the uptake level and coating uniformity on different meshes.

AZoM - Metals, polymers, ceramics and composites - A fluorinated coating on unoxidised mesh (left) and oxidised mesh (right)

Figure 2. A fluorinated coating on unoxidised mesh (left) and oxidised mesh (right).

The results led to the coating system being validated. The client then had sufficient scientific data to pursue the development of a new-coated mesh for medical sensors.

Investigation into the Leakage of a Metered Dose Inhaler

ToFSIMS and XPS were utilised to investigate the cause of a leakage of a metered dose inhaler.

A large white deposit on the valve gasket was identified but this was determined to be a symptom not the cause of the leakage. Further investigations led to the leakage been attributed to the presence of an aluminium rich flake on the valve gasket prior to sealing of the inhaler unit resulting in localised damage of the gasket surface which compromised the seal integrity.

The results showed the cause of the leakage, which was then corrected by the manufacturer.

Further examples of CERAM’s work with Inhalers can be found here.

Analysis to Determine Distribution of a Drug on a Coated Stent

DSIMS depth profiling was utilised to monitor the distribution of a drug from the surface to the stent substrate.

Results showed significant variation in the individual and total coating layer thickness indicating variable deposition rates for the basecoat and the topcoat. After 20 days in a release medium the coating thickness was measured and had reduced from ~20mm to ~5mm.

The coating characterisation results were used to improve the deposition process.

Further examples of CERAM’s work with Stents can be found here.

Source: CERAM

For more information on this source please visit CERAM

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