Manufacturing Engineering
Permanent URI for this collectionhttps://hdl.handle.net/20.500.12475/53
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Item Design of a Cleaning Change Over Reduction Strategy for a High Volume Product in a Packaging Line(Polytechnic University of Puerto Rico, 2010) Alvelo Ortiz, Grisel; Torres, EdgarCurrently packaging operations are trying to reduce the downtime and operational cost among others activities to enhance efficiency and overall process performance. Based on this objective, pharmaceutical packaging operations defined, proved and validated a process that allowed to use five released bulk lots be combined into one packaging lot. The strategy proved to be efficient for operational cost, unproductive time reduction and cross contamination. An identified disadvantage was that if a quality event was noticed in the release product, no bulk segregation could be done. Once each bulk lot is added into the filler machine or product bottle, it was mixed with previous bulk lots and it cannot be determined which tablet belongs to a specific bulk. Redesigned batch record includes a table to estimate the bulk traceability when it is packaged as Combolot. A project to develop a sub-lot numbering system was identified as future wok for this research. Key Terms ⎯ Cleaning validation, campaign, change over, combined lots, packaging lots, process improvements.Item H&K Capsule Filling Equipment Reliability(Polytechnic University of Puerto Rico, 2013) Iglesias, Victor; Torres, EdgarEncapsulation is a process whereby the dose is charged into a hard gelatin capsule; powder, pellets, tablets or combinations of two or more of these may be filled into the capsules. Capsules provide a convenient way of dosing medicines which are not conveniently made into a single tablet or do not provide the desired pharmaceutical effect when dosed as a tablet. The project presented the utilization of DMAIC improvement methodology to mitigate conditions adverse to a capsule filling process, like process downtime and spare parts consumption. The DMAIC process was not limited to the operations directly related to the filling process since several failure root causes are identified includes indirect causes related to storage and handling practices. Downtime impacts not only the production activities schedule and company financial results, also causing product waste. Other consequences include potential non conformance quality conditions and impact to the supply chain in a timely matter. Key Terms- Changeover, DMAIC, Process Downtime, Spare Parts.Item Compression Machines Relocation for Space Optimization(Polytechnic University of Puerto Rico, 2013) Velazquez del Valle, Omar; Torres, EdgarPharmaceutical industries develop, produce and market drugs for use as medications. All pharmaceutical manufacturers are directed to produce in a high optimization environment to increase productivity and ensure product of high quality level. A design process was performed on the compression manufacturing area of a pharmaceutical industry in order to maximize the space to achieve the current production demand, improve the manufacturing process layout increasing the efficiency and the safety on the compression process. DMAIC (Define, Measure, Analyze, Improve and Control) methodology was used as a problem solving tool to identify how to optimize the space. Some of the tools used on this project include brainstorming and decision matrix to determine the best layout alternative to improve the work environment. Key Terms - Compression Machines, DMAIC, Overall Equipment Efficiency (OEE), Tablet Monitoring Equipment.Item Implementation of Innovative Automated Coating Technology in a Medical Device Facility(Polytechnic University of Puerto Rico, 2012) Díaz Cruz, Teresa M.; Torres, EdgarAbstract - As part of new products development in a medical device plant, an innovative coating technology known as Physical Vapor Deposition (PVD) will be implemented for the electrode coating process. Current process is performed by dip coating parts manually and exposing to high temperatures for pre-defined time. This process has a high cycle time from 8 to 10 hours per batch. Additionally the process results in not uniform coating thickness and high variability between parts. The new process to be implemented will be automated where the operator will load and unload parts in the system and press one button to start the process. The PVD technique is performed by sputtering atoms that make up the coating via bombardment of a plate of the coating material by energetic ions. Testing results showed more uniform coating thickness and less variability between parts as well as reducing the cycle time per batch to 45 minutes. Key Terms - Automation , Electrode Coating, Physical Vapor Deposition, PVDItem Vision System Selection Requirements & Implementation In Industrial Automation(Polytechnic University of Puerto Rico, 2012) Rodríguez, Miguel; Torres, EdgarAbstract - The vision systems are part of a new revolution in automation. With the capability of being implemented practically to any application, the benefit of using this kind of systems are multiple but the ones which came out from the rest are the following: the precision in the identification on characters in the different applications, also it allows a very fast recognition and processing. For the precision and huge capabilities, these systems are in a very high demand. But the real challenge is to find the proper system for the specific application, which will allow that selected combination of components execute in the optimal level of performance required for the selected application. Key Terms - Automation, Process, System, Vision.Item Development of Bulk Shipping Studies in Pharmaceutical Industry(Polytechnic University of Puerto Rico, 2012) Marrero Ruiz, Josean O.; Torres, EdgarAbstract ⎯ A bulk shipping study in the pharmaceutical industry consists in monitoring and analyzing the environmental conditions (e.g. temperature and relative humidity) during shipping and transportation of the drug product. The environmental conditions could affect the drug product critical quality attributes such as identity, strength, quality, and purity. The Company X needs to ensure that the shipping process and transportation does not affect the product X quality attributes i.e., safety, efficacy, strength, integrity and purity. The proposed method for this design project is the implementation of data loggers with the product during the shipping and transportation process to record the environmental conditions. Also to ensure that critical bulk product quality attributes are not affected with the exposed environmental and shipping/transportation conditions. Key Terms ⎯ Bulk Shipping Studies, Environmental Conditions, Mean Kinetic Temperature and Mean Relative HumidityItem Equipment Validation Standardization for Project Implementation Time Reduction of Automated Manufacturing Platforms(Polytechnic University of Puerto Rico, 2012) Marín Román, José Xavier; Torres, EdgarAbstract - Medical Device regulated industry requires extensive validation work. Using the latest automation technology for the process equipment to eliminate the operator interaction brings the challenge of how fast the company implements complex equipment requiring validations. After designing the manufacturing equipment of next generation products defining standard manufacturing platforms enables the standardization of requirements between systems. Nevertheless, Installation Qualification brings its challenges for the project timelines due to the nature of the requirements of this process. The project goal was to minimize the project timeline of the next generation product lines using the standard manufacturing platforms by improving the installation qualification process. The DMAIC methodology was used to organize information, delimit process scope, and gather the necessary information needed to make appropriate decisions. The results of the process improvements documented in this research showed an improved process with approximately 50% time reduction. Key Terms - Automation, Installation Qualification, Standard Testing Protocol, Equipment Automation.Item Increase Productivity in a Manufacturing Department of a Medical Devices Company(Polytechnic University of Puerto Rico, 2013) Aponte Nunez, Jonathan; Torres, EdgarIn all companies the productivity is a very important metric because is the way to make sure that we optimize our resources and time. Is the way to measure if we are manufacturing as expected and with the required resources. In this project, the Six Sigma Methodology was used to obtain an increase of at least 5% in the productivity of this manufacturing department in a medical devices company. Six Sigma has a key methodology: DMAIC. DMAIC is used to improve an existing process. Consist in Define, Measure, Analyze, Improve and Control. In this article you will find the results obtained after the implementation of automation and the use of DMAIC as the correct methodology for improvement. Key Terms - Automation, DMAIC, Efficiency, Productivity.Item Quality System Management for Process Analytical Technology Applications(Polytechnic University of Puerto Rico, 2013) Nieves Mercado, Deborah E.; Torres, EdgarCommonly the pharmaceutical industry uses a system known as the traditional or conventional process for the manufacturing of their products. Now, it has been shown that the use of other systems not only benefits in product quality, but also on cost-effective and process efficiency. This is why the Food and Drug Administration has initiated a revolutionary campaign to encourage the industry on implementing new system upgrades. Process Analytical Technology or PAT is a set of tools that will provide with better understanding and control of the process. Some of the benefits provided by the technology revolve in the reduction of production costs by reducing cycle-time and the overhauling of the process for making it more ecofriendly. Both techniques have unique characteristics, but is important to highlight this improvements to the manufacturing process in order to provide us with high quality products in our quest for better quality of life. Key Terms - Analytical Process, Food and Drug Administration, Process Analytical Technology, Traditional Pharmaceutical Manufacturing Process.Item Margin Increase as a Function of Quote Precision Optimization for Packaging Automation Projects and Services(Polytechnic University of Puerto Rico, 2013) Ortega Colon, Luz S.; Torres, EdgarThis document describes design and development of quote optimization process using margin increase as a critical process response. It analyzes the aspects of estimating project or service in the packaging machinery industry. The process begins by acquiring specifications; designing or coordinating resources, time and order fulfillment. Resources considered a range of factors from machinery to spare parts, labor to travel expenditures and hardware accessories. A 35% margin was established as acceptable by customer and management. Invoicing and other metrics acknowledged a profit lower than 35% target. This states an opportunity to increase and maintain goal margin. The procedure and resources were studied to assess over-expenditures deficiencies. Current economy scarceness has increased competition to the extent of company earning trade-offs for "survival". Methodology used included a Pareto diagram which was developed to determine which price range or project scale was most impacted to concentrate efforts and assign causes. Six Sigma methodology: Define, Measure, Analyze, Improve and Control was selected for implementation. Supplier Input Process Output Customer diagram which lists manufacturers, resources, operation, services and clients, was used to evaluate all possible factors impacting the response. Value Added Analysis was performed with resource expenditures derived from invoices reconciled over the year 2013. Standardize, Mistake Proofing, Pull System and Work Balance strategies were combined to generate improvement forms that calculate and keep track of progress performance while enabling scope deviation detection. Key Terms - Margin, Packaging, Quote, Specifications.