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At 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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Dual Component Vial Production Line Validation at a Leading Pharmaceutical Manufacturer in Kalamazoo, MI
At 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 […]
Read MoreHardware and Control System Upgrade to an Illinois pharma manufacturer’s Lyophilizer Cart
AT 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 MoreCritical Utilities Periodic Review Implementation for Global Pharmaceutical Manufacturer
At 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 MoreSemi-Automated & Automated Seidenader (Körber) Inspection System Upgrade with Large Pharmaceutical Manufacturer
At A Glance A client’s current automated inspection system was old and beyond its serviceable life. A new automated filing system and semi-automated system were purchased to increase production detection capabilities for parenteral presentations. New control system required integration with global system Shakedown provided a faster path to successful validation This was a new platform […]
Read MoreDematic Automated Storage and Retrieval System Validation
Overview A global pharmaceutical manufacturer was looking to boost its production capacity due to high market demand but was running out of space at its largest U.S. facility. The manufacturer’s team decided to recapitalize its existing warehouse space to make room for a new device line. After a rigorous qualification process, the manufacturer procured a […]
Read MoreAutomated Storage & Retrieval System (ASRS) Qualification
Pharmaceutical Chilled Storage Facility – Automated Product Storage and Retrieval System C&Q The Challenge A large mid-western pharmaceutical company planned to install an automated product storage and retrieval system (AS/RS) within a new chilled storage facility. The idea was established as a way to better identify and document time the product spent outside of refrigeration […]
Read MoreQuality Assurance – Designed for Construction
The Challenge In 2003, a large pharmaceutical and biotechnology company was experiencing cost overruns, project delays and other cost-of-quality issues that have become the norm on recent projects. Many questions existed and answers were needed for questions such as: Further investigation revealed that the construction industry, as a whole, has been struggling with quality issues […]
Read MoreProcess Automation Upgrade in an Animal Health Manufacturing Facility
The Challenge A large Midwestern animal health manufacturing company needed to move from an old process control automation platform with diminishing upgrade and support options to a newer more customizable and expandable system. The same automation platform was being used for all of the major manufacturing processes at the plant site, from fermentation to recovery […]
Read MoreManual to Automated Process Improvement
Clinical Trials Manufacturing – Conversion of a Manual to Automated Process The Challenge A Contract Manufacturing Organization (CMO) required a process improvement to increase the production capacity for prefilled syringe assembly and labeling operations. This parenteral assembly, labeling, and packaging process was currently being performed manually, but due to forecasted volume increases, an automated process […]
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