The Challenge A Fortune 500 medical technologies firm wanted to increase the production capacity for its products. The intention was to increase capacity with a new production line that was also prepared for future products to be added to the line with minimal changes. This plan saw the addition of a new SCADA controlled production […]
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The service engineering department of a leading medical device manufacturer developed a fully custom medical device programming system for distribution to its global service centers. This new programming system was a down-scaled version of a larger and more complex automated system that the client used in production for the testing and programming of electronically driven […]
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The Challenge A leading medical device manufacturer sought to add a new product to an existing production line. This required a retrofit of the previously validated line, requiring an assessment to determine if existing documentation met current regulatory standards. Additionally, new processes and simple fixtures were being added to the production line to accommodate the […]
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A Michigan based Fortune 500 company and leader in medical device technologies initiated a project to upgrade their existing Axeda® system application to the latest software version. Axeda®, recognized as a front-runner in machine-to-machine (M2M) technology on the Internet of Things (IoT) environment, offers a highly customizable software package with user interface, expression rules, and two-way […]
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The Challenge A Fortune 500 medical device manufacturer wanted to add a new laser welder to their production facility to improve manufacturing throughput and reduce scrap rate. The engineering staff at the medical device company were familiar with the equipment and its intended use; however, this model of laser welder had not been previously used […]
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Challenge A large mid-western pharmaceutical company embarked on a large capital project to increase their global production of several drugs. This expansion project required the construction of three (3) new buildings, as well as various utility and manufacturing equipment additions. The scope of Performance Validation’s commissioning and validation work including the following systems: Solution Performance […]
Read MorePerformance Validation has extensive experience with refrigerators, freezers, and sub-freezers from execution of qualification/validation projects with multiple clients across Pharmaceutical, Animal Health, and Medical Device life science industries. These projects included mapping studies using PV’s own inventory of wireless Vaisala temperature and humidity data loggers and low-temperature loggers. Performance Validation resources have expertise in determining […]
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Overview A Greenfield construction project of a new administrative office for an Indiana Pharmaceutical Manufacturer required building commissioning of all utility systems, including HVAC, chilled water, plant steam, heating hot water, compressed air, electrical/lighting, and sanitary and storm sewer systems. The SolutionThe pharmaceutical Manufacturer retained Performance Validation (PV) to perform the building commissioning. PV was […]
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Overview Life within an API manufacturer can be characterized as dynamic, fluid and fast paced. Projects may include large capital projects for the installation of new equipment or remodeling/repurposing of existing equipment and spaces. Alternatively, projects may consist of minor piping changes, equipment additions, decommissioning, repairs, pump replacements, solvent additions, pack-out equipment, and facility upgrades. […]
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Overview A cell culture laboratory within a large Midwestern pharmaceutical company needed to upgrade their current cell freezing process. the project included replacing an older and increasingly unreliable controlled rate freezer with a new controlled rate freezer. Additionally, the actual freezing rate of the cells within the controlled rate freezer was needed to be determined […]
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