Process development
We use our process expertise to assist customers within the 4 categories below:
- Process development
In connection with development of a new product the challenge is to ensure that product, process, equipment, and validation requirements come together to a robust, balanced solution. - Process optimization
Why is the process not robust? What are the fundamental product-process interactions? We do more than just turn dials and crunch numbers and try to find robust solutions by design. - Process characterization
You need to validate your machine. What are meaningfull process parameters to test and what does the process actually do? We can assist you in understanding the fundamentals of the process and to focus control in the right direction. - Production trouble shooting
Is it an incoming product quality issue, a fundamental process issue or a production issue? We can assist you in finding proper cause and effect and take action accordingly.
Process development projects
Chempilots has successfully assisted customers with the development of new processes in the following situations as example:
- Construction of 3 generations of soft contact lens production platforms over the past 20 years
- Automated production of hydrogels for implantation
- Coating of guidewires and catheters
Process optimization and characterization
The Chempilots approach to process optimization and characterization provides a meaningful supplement to standard SPC methods with focus on analysis. This is based on a hands-on product inspection and process observation involving:
- Identification of suitable and meaningful metrics and development of analysis methods or equipment to probe for these (both product and process parameters measured at the product level)
- Fundamental physical and chemical process interaction analysis
- Hypothesis and cause-effect testing through stressed experiments
In our experience, this is especially a valuable approach in combination with SPC when the process system is basically ill designed or not well understood. It is also useful when solutions need to be found by changing the process setup or method, rather than merely adjusting the parameters.
Process technology examples
We have broad experience with standard medical device processing operations including:
Contact us for a discussion
For a confidential discussion of how we can potentially assist you, please call Christian Elbek directly on +45 44 39 61 07 (9-17 CET) or send him an e-mail.
