At A Glance Performance Validation (PV) was enlisted by a renowned Michigan-based medical device manufacturer to facilitate a complex and strategic relocation of eight production lines. This project involved transferring the manufacturing of ear, nose, and throat (ENT) single-use, sterile devices to a newly established facility in Kalamazoo. The primary goal was not just the […]
Read MoreAt A Glance PV played a crucial role in collaborating with a major pharmaceutical manufacturer in Michigan to upgrade an obsolete Siemens Programmable Logic Controller (PLC) responsible for controlling the thermal oxidizer (TOX) used in the production of active pharmaceutical ingredients (APIs). The TOX system served as a mission-critical component, and its reliance on the […]
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At a Glance: The Performance Validation Team completed a comprehensive commissioning project for the expansion and renovation of the Graham-Kapowsin High School Health Center, situated within the Bethel School District. This initiative aimed at significantly enhancing energy efficiency, operational proficiency, and ensuring seamless system functionality across 60,000 square feet of classrooms, an auxiliary gym, and […]
Read MoreAt A Glance: A well-established pharmaceutical manufacturer in Kalamazoo, Michigan, embarked on a critical initiative to upgrade their production capabilities, focusing on the implementation of a dual-component vial system. Recognizing the complexity and importance of this project, the manufacturer entrusted Performance Validation (PV) as their validation partner. PV’s expertise was vital in addressing the evolving […]
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AT A GLANCE: Our team conducted a comprehensive two-phase commissioning process for a recently constructed high school and performing arts center within the Snoqualmie school district. Our primary objectives were to ensure the energy efficiency of the buildings, guarantee their seamless operation, and provide the training and tools to empower the maintenance team to keep […]
Read MoreAT A GLANCE A pharmaceutical manufacturer in Illinois requested Performance Validation’s expertise to carry out a two-stage upgrade for their existing process responsible for sterilizing, filling, freeze-drying, offloading, and capping vials. The first stage of the project focused on two large lyophilizers and were executed while production was ongoing, while the second stage focused on […]
Read MoreAt A Glance A prominent pharmaceutical manufacturer on a global scale was seeking to integrate periodic reviews in their quality process to detect qualification gaps, undocumented system modifications, deviation trends, as well as maintenance and calibration issues, negative trends in system performance, and inadequacies in the development of required legacy documents. In collaboration with the […]
Read MoreAt A Glance Our team conducted a comprehensive 1-day smoke study for a pharmaceutical client based in Illinois. Although this study was not mandated by the Food and Drug Administration (FDA), it held immense significance for our client. The primary objective was to verify the safety of their employees throughout the production process of a […]
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At A Glance Our team planned and executed the validation of a system update for a large pharmaceutical manufacturer’s pre-fill syringe Systech serialization systems. The client’s systems required updating from Microsoft Windows XP to Microsoft Windows 10, as well as upgrades to new cameras, other hardware, software, and data protection controls. All of this required […]
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AT A GLANCE: A major pharmaceutical manufacturer near Fort Collins, CO required a team of skilled and experienced professionals to complete a smoke study within their aseptic syringe filling suite. DIFFERENT APPROACH TO FIT CLIENT’S NEEDS When Performance Validation (PV) initially met with our client; they stressed the importance of requiring a team of experts […]
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