Cetry Service: Characterization & Modelling

Characterization of products and processes forms the backbone of product development and process engineering. When combined with modelling, it surpasses trial and error and opens doors to new or optimized manufacturing methods and product properties. The model describes the process or product and can be extrapolated to new areas. Many new techniques have only become possible by modelling of datasets that were obtained by characterization tests. Cetry has a track record regarding characterization and modelling of physicochemical processes, of coaxial catheter system performance, of medical coatings and of surface modification methods.
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Modelling of tests and processes enables optimization, stabilization, justification and risk management. Think of tests for product quality control or tests for in-process control. Cetry is able to assist with test definition, test evaluation, modelling, optimization and validation. We can also help out in finding what tests are essential and what criteria have to be met, e.g. based on regulatory requirements. The following list gives an impression of what we can do for you:

• Definition and implementation of required and desired in-process controls (IPC) for manufacturing
• Definition and implementation or required and desired product quality controls (QC)
• Definition and implementation of required and desired tests for incoming materials (IC)
• Definition and implementation of calibration requirements, based on processing modelling and risk management
• Process modelling for optimization and risk control - tolerances, speed, alternatives, quality
• Process validation
• Modelling of test methods for optimization and risk control
• Test method validation - e.g. lab tests for product quality control
• Modelling of in-process validations and calibrations

Accelerated aging of products under development greatly reduces the development cycle time. Problem is, however, that the acceleration method must properly relate to aging in real time. Cetry is able to assist in finding a representative acceleration method for thin layers and finished products. Think of:

• Definition and implementation of transportation simulation tests
• Definition and implementation of long-term storage simulation
• Definition and implementation of application wear simulation
• Identification of relevant specific aging parameters
• Characterization and modelling of the aging process into an accelerated aging procedure
• Justification of the accelerated aging method in light of ISO 10993, pharmacopeia, risk management, existing CE registration, etc.

Click here for some background information regarding aging of coatings and medical devices

Being specialized in development and application of coatings for medical devices, Cetry is able to assist with characterization and modelling of existing and new coating systems. Think of:

Curing - how does it work? - how long before the product can be packaged and sterilized?
• UV lighting techniques
• Dip-coating techniques
• Drying mechanisms
• Surface cleaning
• Surface modification effectiveness
• Adhesive bonding effectiveness
• Aging and deterioration of coatings and adhesive bonds
• Product performance of medical coatings in vivo and in vitro
• Particulate matter generation by coatings
• Medicine leaching (speciality: heparin)
• Coating functionality aspects, such as lubricity or anti-thrombogenicity

Cetry is able to perform characterization tests on-site, e.g. in the light of test optimization, trouble shooting, and product qualification. These on-site tests are done with available equipment in co-operation with the company's own personnel. All clients have appreciated the hands-on approach, which led to new and improved characterization methods that could be implemented straight away after training of the test-lab technicians.
Cetry also offers a limited range of in-house tests, such as:

• Heparin leaching test (typical resolution: 0.02 IU per square centimeter)
• Static friction testing, dry or wet (typical resolution: 0.01)
• Surface tension measurements
• Pull testing
• UV/VIS measurements
• Qualitative surface cleanliness tests, e.g. for identification of handling problems (which gloves can be used? - what packaging? - etc.)

Cetry can assist with characterization of products for purpose of qualification and registration. What tests need to be done in light of ISO 10993 or other norms? What criteria are to be applied? What is required by law? Our assistance covers e.g.:

• Translation of the Essential Requirements list into product characterization in practice
• Definition and implementation of functional characterization
• Definition and implementation of safety testing
• Predictive modelling of product performance
• Risk analysis
• Guidance and/or implementation of product qualification
• CE registration