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At A Glance An Indianapolis-based contract development and manufacturing organization (CDMO) for injectable pharmaceutical manufacturing partnered with Performance Validation (PV) for cleanroom recovery testing. During a client’s compliance audit relating to ISO 14644 and EU Annex 1 requirements, the CDMO realized they lacked proper testing documentation demonstrating room recovery requirements. This discovery led to the […]
Read MoreAt a Glance An Indianapolis-based logistics company looking to cold-store vaccines partnered with Performance Validation (PV) to validate its electronic quality management system (eQMS). The logistics company, which had GMP storage facilities with walk-in freezers, wanted to use their extra space to stockpile COVID-19 vaccines. Before this could happen, however, the company would need to […]
Read MoreAt A Glance One of the largest pharmaceutical manufacturers in the Midwest partnered with Performance Validation (PV) to perform environmental mapping in its brand-new facility in Research Triangle Park, North Carolina. The pharmaceutical manufacturer expanded its operations by building a new campus to increase production capacity. One of its buildings included a quality control laboratory […]
Read MoreAT A GLANCE An equipment manufacturer of high-speed automated assembly machines in Illinois partnered with Performance Validation (PV) to validate its drive/reject assembly machine. The equipment manufacturer was a vendor for one of the largest pharmaceutical manufacturers in the Midwest. The pharmaceutical manufacturer needed to produce more auto-injector pens for its drug products, so it […]
Read MoreAT A GLANCE One of the largest pharmaceutical manufacturers in the Midwest partnered with Performance Validation (PV) to inspect its vial production process. The pharmaceutical manufacturer had two main objectives: The PV team had nearly a decade of experience supporting the inspection process for the pharmaceutical manufacturer, which allowed them to build expertise with the […]
Read MoreAt A Glance The Performance Validation Team completed a comprehensive commissioning project for the brand-new Benton County Administration Building in Kennewick Washington. The project broke ground in July of 2020, and reached completion in March of 2023. The new administration building spans three stories and encompasses 41,419 square feet, including a fully equipped basement. This […]
Read MoreAT A GLANCE A top 5 pharmaceutical manufacturing company in North Chicago, Illinois, partnered with Performance Validation (PV) to perform smoke studies in a building with 14 different areas for packaging, filling, mixing, and bottling. For each area, the team conducted three scenes: a baseline, a material airlock examination, and a personnel airlock examination. The […]
Read MoreAT A GLANCE The Performance Validation Team expertly conducted a comprehensive commissioning project as the primary commissioning authority for the City of Marysville Civic Center. This new facility is a cornerstone of the downtown redevelopment plan, designed to create a one-stop campus for city services. Spanning 101,000 total square feet, the Civic Center integrates a […]
Read MoreBased on the increased use of computer systems in the pharmaceutical industry,the United States Food and Drug Administration (US FDA) issued the 21 CFR Part 11regulations in March of 1997. This regulation provides the criteria for acceptance bythe FDA, under certain circumstances, of electronic records, electronic signatures,and handwritten signatures executed to electronic records as equivalent […]
Read MoreAT A GLANCE The Performance Validation Team successfully completed a comprehensive commissioning project of Olympic Middle School for the Auburn School District. The new facility, supporting grades 6 – 8 was constructed on the existing site while the previous facility remained operational. After the new facility’s completion, the previous building served as an interim school […]
Read MoreAt A Glance The Performance Validation Team has successfully completed a comprehensive commissioning project for the City of Bellingham’s Public Works Admin Center & Vehicle Barn as a third-party commissioning provider. Executed in collaboration with RMC Architects, SpeeWest Construction, and several other contractors to successfully deliver a substantial expansion and modernization effort for the City […]
Read MoreAt A Glance The project focused on launching a new advanced medical drilling system aimed at enhancing surgical precision and effectiveness. Spearheaded by a leading medical device manufacturer, the project included a rigorous Production Part Approval Process (PPAP) to ensure all components adhered to the highest quality and safety standards. This project represented a significant […]
Read MoreAt a Glance The Performance Validation Team successfully conducted a thorough commissioning project at Bates Technical College for the Center for Allied Health Education, formerly the Medical Mile Health Science Center. This cutting-edge, three-story educational facility spans 65,000 square feet including a dedicated parking level. The facility serves as an advanced addition to the college […]
Read MoreAT A GLANCE The Performance Validation Team completed a comprehensive commissioning project for the Quileute Tribal School in La Push, Washington. This K-12 school serves as a vital educational hub for the students of the tribe while also doubling as a central community space. The previous school was built right off the water posing safety […]
Read MoreAT A GLANCE The Performance Validation Team successfully completed a thorough commissioning project for the Artise in downtown Bellevue, Washington. Built in collaboration with developer Schnitzer West and general contractor Sellen Construction, the Class A core and shell build epitomizes both innovation and sustainability. The office tower stands tall with just over 600,000 square feet […]
Read MoreAt a glance In a landmark project within North Carolina’s Research Triangle Park, Performance Validation (PV) executed a comprehensive temperature mapping study for a leading pharmaceutical manufacturer’s state-of-the-art Automated Storage Retrieval System (ASRS) facility. Spanning two crucial storage areas—Controlled Cold Temperature (CCT) with >9000 pallet positions and Control Room Temperature (CRT) with >8000 pallet positions—the […]
Read MoreAt A Glance: The Performance Validation Team conducted a comprehensive building tune up for the Edmonds School District, encompassing 30 buildings across elementary, middle, and high schools in addition to supporting district facilities. Our primary objective was to enhance the buildings system performance and establish a more accurate energy usage baseline for the Washington Clean […]
Read MoreAt 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 […]
Read MoreAt 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 […]
Read MoreAT 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 […]
Read MoreAt 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 […]
Read MoreAT 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 […]
Read MoreAt 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 MoreAt a glance: A medical device manufacturer was looking for assistance to make their Enterprise Resource Planning (ERP) system FDA compliant for an external audit coming up later in the year. CHALLENGES: The client did not have internal capabilities or the bandwidth to complete the validation. Their team lacked the expertise and knowledge to execute […]
Read MoreOverview 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 MorePharmaceutical 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 MoreThe Challenges A manufacturing division of a major pharmaceutical corporation owned and operated a number of Kaye Validator thermal validation systems. Historically, the facility’s Metrology department had outsourced the scheduled calibration of the Kaye Validators and their sensor input modules (SIMs) to the vendor, which limited their control over the time it took to return […]
Read MoreThe Challenge A global organization that develops, manufactures and sells diagnostic instruments and related software needed validation for their cloud based Electronic Data Capture “EDC” platform, “IBM Clinical Development” to help reduce the time and cost of clinical trials. Their clinical sites would enter study data into the software and it would expedite their data […]
Read MoreThe 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 MoreThe Challenge The 2016 publication of FDA draft guidance document (“Data Integrity and Compliance with CGMP”) along with increased warning letters / 483s have generated an increased attention toward data integrity issues among FDA regulated industries. As a result, companies in the affected industries have begun instituting or updating their data integrity policies and best […]
Read MoreThe Challenge A leading medical device company was underway on two projects intending to launch new global business information systems; an electronic CAPA management system and a product complaint handling system. Both systems were being developed in a TrackWise® system environment with the collaboration of the software vendor, Sparta Systems, and the in-house development team. […]
Read MoreThe 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 MoreClinical 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 […]
Read MoreThe Challenge A client contacted Performance Validation requesting assistance with qualification of a new product packaging line for a bagged dry product to allow for serialization and reduction in personal protective equipment (PPE) required by operations. This system was to be installed in a parallel room with tie-in to the existing packaging line to allow […]
Read MoreThe Challenge A client contacted Performance Validation requesting assistance with qualification of additions and modifications to an existing cell culture purification suite to expand the product line capabilities of a newer acquisition facility on a tight production shutdown window. Additionally, this client requested assistance with replacement of their obsolete washers and autoclaves, expansion of their […]
Read MoreThe Challenge A large pharmaceutical company planned a new construction finished drug product distribution warehouse located in Indianapolis. The project included controlled room temperature (CRT) storage, refrigerated storage, and freezer storage for products as well as an attached administrative office area. The project was part of a pilot project delivery method and involved adapting an […]
Read MoreThe Challenge A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with the commissioning and qualification of a new blister card packaging line for a new product launch, as well as facility and utility modifications to support the new packaging line. The packaging line was intended primarily for a new product that was […]
Read MoreThe Challenge A Midwestern pharmaceutical company planned to upgrade their in-process checks for blister card integrity from a destructive blue dye leak test to a non-destructive, vision system-based leak test. The existing blue dye leak test required that all tested blister cards be discarded even if they passed. This caused the customer to lose money […]
Read MoreThe Challenge A Midwestern diagnostic company desired to bring a DNA based diagnostic to market as an FDA approved medical device. The device would be cleared through the FDA PMA approach and would be the companies first FDA approved medical device. A parallel submission (FDA/CMS) would be utilized. The technology represented an innovative, groundbreaking approach […]
Read MoreThe Challenge An Animal Health Facility in Georgia desired to increase the production capacity of an API in order to meet anticipated customer demand. This product is an innovator in helping to meet the future demand for affordable food. Rather than simply adding duplicate capacity, the facility desired to achieve the capacity increase through process […]
Read MoreThe Challenge A leading pharmaceutical packaging company planned to migrate their outdated Building Management System hardware which controlled and monitored their freezers, coolers and packaging suites to their existing BMS system. The monitored temperature controlled spaces contained product during the migration. In addition, the software for the AHU for the packaging suites was also upgraded. […]
Read MoreThe Challenge A mid-sized medical device company, subject to cGMPs, needed to bring their legacy Enterprise Resource Planning (ERP) system into FDA compliance. The system is called Sage 100. They had not validated it in the past. This was clearly a concern to them and a gap they needed to mitigate as soon as possible. […]
Read MoreThe Challenge A leading health care research laboratory contracted Performance Validation (PV) to create a Computer System Validation (CSV) package for a multiplexing laboratory system. This system is used to perform quantitative analysis of proteins and nucleic acids in a variety of sample matrices for their clients. The instrument and its data acquisition / analysis […]
Read MoreThe Challenge A large mid-western pharmaceutical company planned to upgrade their Manesty, HATA, and Korsch Tablet Presses (30 Presses total) with a Tablet Press Automated Controller (TPAC) to better control the manufacturing process and provide user security levels and functionality along with a standardized operator interface. An additional challenge is that during the project innovations, […]
Read MoreThe Challenge A large Multi-National Medical Device company was seeking to expand manufacturing operations in Asia. This new manufacturing site located in China, needed to develop and implement a complete quality system, and satisfactorily complete local and corporate audits in preparation for facility startup. The Solution Performance Validation provided consultants to assist the client team […]
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