Conduct a technologies identification, technical screening, and technical and economic evaluation for process improvements to a tinting process at a medical device manufacturing facility.
MEDICAL DEVICE TINTING PROCESS UPGRADE TECHNICAL AND ECONOMIC EVALUATION
The client, a medical device manufacturing company, owns and operates a batch pledget tinting process in which the dye is blended, applied to the pledget, and then the pledget is dried at ambient conditions. Current manufacturing methods require a significant level of operator interaction and are carried out in such a way that significant variability in batch cycle times are encountered. Due to a projected increase in product demand, the client is considering upgrading the current scheme. Process Engineering Associates, LLC (PROCESS) was asked to assess the technical feasibility of potential systems for use in this service. Specifically, PROCESS was asked to identify technologies to reduce cycle times, improve product consistency, and reduce solvent vapor emissions. PROCESS completed the following tasks in support of this effort. To this end, PROCESS conducted a technologies identification, technical screening, and technical and economic evaluation, which included the following major tasks:
- Conducted an on-site tour of the facility to view the current process and gather relevant data
- Identified candidate systems suitable for the process considering the overall operating goals
- Completed preliminary process simulations using PROCESS' licensed computer simulation software, CHEMCAD, to estimate general process conditions and relative cycle time improvements
- Discussed process requirements with equipment manufacturers to gauge initial feasibility and any potential technical issues
- Developed a ranking system to weigh benefits versus risks (including costs) and quantitatively ranked each alternative to prioritize systems for further consideration by the client.
The development of a ranking system allowed PROCESS to quantitatively rank alternatives at a minimal cost to the client. PROCESS was able to determine qualitatively that an improvement in the drying process would bring the most return to the client from a process improvements standpoint and technically-screened three alternative technologies: (1) cone dryer, (2) double cone dryer, and (3) tray/shelf dryer. The following technical and cost factors were assigned importance ratings and each alternative was ranked quantitatively with respect to these factors:
- Labor costs
- Operating costs
- Capital costs
- Reduction of operator exposure
- Solvent recovery potential
- Technical risk
- Development time
- Cycle time reduction potential
- Space requirements
- Integration with the current process
- Potential to damage product.
Results from the tasks above were summarized in a written report and submitted to the client to facilitate their decision process.
- Medical Devise Manufacturing
- Process improvement study
- Technical screening study
- Alternatives evaluation
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