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Monomer’s Residuals Test Elimination for Soft Acrylic Buttons at Polytechnic University of Puerto Rico
(Polytechnic University of Puerto Rico, 2022)
In the cataract surgery, the natural lens in the eye is replace with an Intraocular Lens. Five monomers (EA/EMA, TFEMA, EGDMA, UV Chr) are mixed to produce the soft acrylic lens. Residual monomer testing ...
Labeling and Packaging Process Improvement Using DMAIC Methodology
(Polytechnic University of Puerto Rico, 2022)
Medical Device Companies must ensure that each unit of product has unique identification and that it is labeled correctly. Labeling requirements include having the appropriate data on the label, not ...
Change Control Routed with Missing Information Delaying Approval and Implementation Date
(Polytechnic University of Puerto Rico, 2022)
The approval of manufacturing change control for MedDevice Inc., is currently acting lower than target(15 business days). Based on a 12-months data review, the lead time of approval of a change is approximately ...
Radio Frequency Identification Tags (RFID) Configuration Application for Medical Device Industry Supply Chain using DMAIC Methodology
(Polytechnic University of Puerto Rico, 2022)
To align data control at inner cell an RFID Configuration Application was developed with the intend to reduce lost traceability issues. Six Sigma strategy following the DMAIC methodology mas used as guidance to define the ...
New flow route for the delivery of the to be cleaned filling equipment for the lot-to-lot changeover optimization using the lean manufacturing methodology
(Polytechnic University of Puerto Rico, 2022)
Management demand to reduce downtime in manufacturing had increased in recent years. This led manufacturing to use the Lean Methodology and Six Sigma tools to optimize the process. Focused on process improvement and ...
Global Supplier Quality Performance Monitoring Scorecard
(Polytechnic University of Puerto Rico, 2022)
Monitoring the performance of suppliers in any industry ensures the continuos improvement of the relationship between a supplier-customer through the identification of gaps between the current performance and the customer ...
Improve HTS and Schedule B Classification Process to Reduce the Turnaround Time in a Commodity Shipments Compliance Project
(Polytechnic University of Puerto Rico, 2022)
The HTS and Schedule B classification process adds two days to the turnaround time of the standard process of the Commodity Shipments Compliance team. Throughout 2021, 108 of 326 requests approvals, requiring HTS ...
Molecular Weight Test Method Validation and HPLC System Qualification
(Polytechnic University of Puerto Rico, 2022)
The Molecular Weight (Mw) Test Method is performed by a contract laboratory. Performing the method externally affects the product release timeframe and represents additional costs when the results are required to be expedite. ...
Granulation Area Capacity Increase
(Polytechnic University of Puerto Rico, 2022)
Manufacturing pharmaceuticals are continuously looking for waste reduction to improve their processes and increase the manufacturing output. Granulation area capacity increase was evaluated for a solid dosage pharmaceutical ...
Manufacturing Process Coordination through Visual Analytics Tools
(Polytechnic University of Puerto Rico, 2022)
This research project was focused on the identification of requirements and the design of a software application toolset, which facilitates and improve the coordination of pharmaceutical manufacturing production steps. The ...