Cetry Service: Development & Manufacturing Support

Cetry is able to provide assistance for medical device/materials development and manufacturing at all levels, ranging from concept to implementation and validation. The topics listed below give an impression of the fields we have been active in to date.
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Output of the manufacturing process is to be monitored by means of product quality control (QC). Cetry is experienced in setting up, improving and debugging quality control methods/test for medical devices and medical materials (such as excipients). Elements are:

• Evaluation of requirements for Quality Control of the specific product(s)
• Specification of test-criteria, in compliance with risk management, regulatory requirements, norms, and product claims
• Setup and implementation of the actual tests
• Qualification of the QC test methods
• Specification of calibration and maintenance requirements for the supporting equipment and environment
• Specification of training requirements for personnel
• Specification of requirements for involved materials and accessories

Proper monitoring of manufacturing processes in a quality-driven environment forms a challenge for many medical device/material manufacturers. What indicators are to be used to ensure stable processing? What criteria are to be set and met? How do the tests relate to product quality and risk management? Cetry is experienced in the field of in-process control, e.g. regarding:

• Evaluation of essential requirements for in-process controls (IPC)
• Setup and implementation of effective in-process controls (IPC)
• Validation of in-process control methods
• Validation of manufacturing methods
• Linkage of in-process control to process stability and product risk management
• Linkage of in-process control to material management (e.g. how to detect in line whether materials are not performing?)
• Linkage of in-process control to performance of equipment and environment
• Specification of calibration and maintenance requirements for the supporting equipment and environment
• Specification of training requirements for personnel
• Specification of requirements for involved materials and accessories

It is often necessary to update an existing process in order to increase output and decrease cost. Quality-driven manufacturing processes must also be optimized for output stability and minimized possible product failure. Cetry is able to assist with setting up and implementing optimization cycles within the triangle of cost, output-quality requirements and throughput. Think of e.g.:

• Evaluation and modelling of manufacturing processes for purpose of optimization and upscaling
• Evaluation of essential criteria for quality-driven manufacturing of the specific product(s)
• Evaluation of minimum criteria for the manufacturing environment (is the cleanroom actually required for this process?)
• Evaluation of minimum criteria for calibration and equipment maintenance
• Improvement of in-process control (see section above)
• Setup and implementation of process (re-)validation
• Finding room for improvement within the existing set of procedures / system
• Justification of changes, for purpose of quality assurance and regulatory compliance
• Translation of customer complaints to manufacturing malfunction plus actions for repair and improvement
• Setting up and helping implement failure mode and effect analyses (FMEA)

Problems with products, manufacturing processes, and materials often require a specific approach in quality-managed plants. Medical devices and materials are subject to stringent rules that have to be obeyed in order to maintain access to the market. Customer feedback and trend-breach of quality control results are to be taken very seriously. Cetry has helped medical device and materials manufacturers to tackle some very nasty problems regarding product and processing failure. We may be able to help you too, e.g. with:

• Interpretation of customer complaints in relation to manufacturing processes and product definition ("translation")
• Perform (partial) risk analysis, related to the problem
• Evaluation of manufacturing processes, materials, personnel, working environment, in relation to the problem(s)
• Evaluation of handling, storage and transportation of products and materials, in relation to the problem(s)
• Evaluation of effectiveness of in-process and quality controls (IPC and QC)
• Evaluation and interpretation of complaints statistics, e.g. in relation to risk assessment
• Running an assessment of the risk-benifit balance related to possible clinical difficulties with the product(s)
• Setting up and helping implement failure mode and effect analyses (FMEA) for the involved manufacturing processes
• Sitting in on a risk analysis session, as independent member
• Definition and build of an off-line simulation that helps study the related phenomena
• Setting up trial runs in light of the problem-solving effort

Cetry has a proven track record regarding development of medical coatings and implementation of related processes, controls, registration, and quality assurance. Please refer to the PRODUCT page in order to find out more about some of the in-house developed coatings. As independent party, we are able to offer support to our customers regarding:

• Coating optimization - functionality - integrity - adhesion
• Coating process repair and optimization
• Coating selection for optimum device functionality
• Coating tests - both in vitro and in vivo
• Coating materials research
• Coating risk analysis
• Troubleshooting of coating processes
• Validation of coating processes
• Troubleshooting of coating performance failure
• Modelling and characterization of coating, process, and performance
• Definition and implementation or upgrade of in-process controls (IPC)
• Definition and implementation or upgrade of coating-related quality control (QC)
• Definition and implementation or upgrade of tests for incoming coating materials (IC)
• USP / EP compliant testing of particle generation caused by coatings

Cetry gladly lends a hand when it comes to implementation of processes, especially in the field of medical device/material manufacture and development. Think of e.g.:

• Installation Qualification and Operation Qualification (IQ/OQ)
• Process performance evaluation / trial runs / validation runs
• Process validation
• Definition and implementation of the right in-process controls
• Definition and paperwork regarding materials and accessories - e.g. materials specifications and incoming control (IC)
• Help set up and implement programs and criteria for maintenance and calibration

Having experience in the field of medical device/materials manufacture and development - from the cradle to the grave - Cetry is able to independently assist manufacturers and developers by setting up and implementing:

• Process/manufacturing validations - in compliance with relevant norms and regulation
• Product qualification - in compliance with relevant norms and regulation
• Validation of test methods, including in-process controls and calibration
• Re-validations and re-qualifications (full-blown or partial)