Processing & Manufacturing Support

We offer:

• Solubility Product Determination
• Cleanliness Validation
• Contamination Analysis
• Coating Characterisation
• Passivation Studies
• Quality Assurance
• Powder Processing/Rheology

Solubility Product Determination

CERAM now offers solubility product determination of powders and coatings in line with FDA requirements. As the interface between an implant surface and the human body is critical, the need to assess the likely solubility of any coating present is essential in order to ensure the safety of the device. The method references the device coating or the raw material utilised in the coating procedure against NIST Standard Reference Materials.

Cleanliness Validation

Achieving and maintaining cleanliness throughout the manufacturing process is critical to the medical device industry. Contaminants can be introduced at each phase of manufacture (such as as milling, turning, blasting, polishing, lapping, deburring, laser treatment, printing and surface modification such as plasma deposition). Understanding and monitoring the effectiveness of each cleaning stage, by surface analysis, residue analysis and particulate assessment, means that not only can we help manufacturers to confirm the final cleanliness validation of the process and products but can also monitor each step to determine where contamination is introduced when problems occur.

CERAM provides a complete validation service for the medical device manufacturer, VALIDATA, to determine the effectiveness of the cleaning process and environment on an ongoing basis. The service includes a unique cleanliness index to quantify product/process changes, troubleshooting facilities to help pinpoint and solve cleanliness issues and the availability of specially-designed test coupons (either ‘off-the-shelf’ or bespoke).

Contamination Analysis

Contamination of any medical device causes product failure, product recalls and, in some cases, can close production lines. By determining the chemical composition of a contaminant, including stains, discolorations, deposits, fibres, particulates and thin film residues, and by validating the cleaning process and the production/manufacturing process, contaminants and their source can be identified and eliminated quickly and effectively.

Coating Characterisation, Including Drug Release

With the development of drug release coatings and sophisticated surface treatments such as plasma deposition and activation, the need for precise characterisation of the outer surface of any medical device becomes increasingly critical. CERAM can determine the chemical composition of a coating, measure its thickness, characterise multi-layer coatings and provide topographical information such as surface roughness, porosity and void volume.

Passivation Studies

With the environmental advantages of citric acid passivation many medical device manufacturers are moving away from traditional nitric acid. The change in manufacture results in a need to understand the passivation properties of both acids to ensure that any change is not detrimental to the product. At CERAM we can determine the oxide thickness layer and uniformity and can chemically characterise the surface and interfaces to ensure that no contaminants have been introduced and that the passivating acid has been removed.

Quality Assurance

We work with medical device manufacturers to develop and provide quality assurance programs to ensure product and material quality consistency and performance to criteria. We offer batch-to-batch conformity testing, from which results can be utilised for regulatory authorities, including FDA, and internal QA/QC protocols.

CERAM has developed a technique called Low Volume Gas Analysis (LVGA). LVGA is a critical analytical tool for orthopaedic medical devices, where moisture concentration can cause a number of long-term issues such as reliability, corrosion, fogging and leakage.

Powder Processing/Rheology

Control of powder properties during processing and in the end product can be a complex issue, especially when dealing with diverse raw materials, varying specifications and multiple performance measures.  Our understanding of these variables allows us to identify root causes and find solutions to a wide and comprehensive range of powder processing issues in the medical device industry; thereby improving product yields, specification quality and, ultimately, increasing customer satisfaction.