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The Challenge A Pharmaceutical Manufacturer in Indiana requested help from Performance Validation (PV) with the commissioning and qualification of a continuous manufacturing process train. The process train was the first commercial continuous manufacturing suite for the company. The continuous manufacturing process closely mimicked a process train in the development area. Overview The Continuous Manufacturing process […]
Read MoreThe Challenge A large global CMO desired to replace an existing Product Lifecycle Management System. The new Product Lifecycle Management System would be housed at a corporate location, accessed globally and house all product data and documentation. The project team was a diverse group consisting of the CMO, the software vendor, the software integrator, and […]
Read MoreOverview A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with commissioning and qualification of a fleet of innovative mobile research units for use in clinical trial research to meet an accelerated schedule. The mobile research units provided several functions critical to conduct life-saving clinical trials by enabling ‘pop-up’ research centers to connect […]
Read MoreA leading medical device manufacturer sought to validate a new SCADA (Supervisory Control and Data Acquisition) system to be used in support of the assembly processes for both an upgraded product line and a new product line. This project launched the client’s initiative to leverage electronic process control technologies to improve efficiency and quality control […]
Read MoreThe Challenge A medical technology company was upgrading their enterprise resource planning (ERP) software system to the latest Sage X3 platform in order to improve their efficiencies in accounting, distribution, and manufacturing. They would be implementing the Sage X3 platform as a SaaS (Software as a Service) with a browser-based interface. The scope of the […]
Read MoreBackground: Often when contemplating a GMP application software project it is desirable to use the software vendor’s protocols to minimize cost. It would be natural to assume that the vendor’s protocols should provide a cost savings, as the vendor’s protocols had previously been executed as part of the testing to release the software for commercial […]
Read MoreThe Challenge A pharmaceutical manufacturing company recently had several autoclave sterilization cycles that were very long in duration, resulting in premature failure of stopper and seal RTP bags. The cycles had been developed and validated years ago and the company did not have much in-house autoclave/sterilization expertise. Additionally, they only had one autoclave to support […]
Read MoreThe 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 […]
Read MoreThe 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 […]
Read MoreThe 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 […]
Read MoreControlled Temperature Storage Performance Validation has extensive experience with controlled temperature and humidity storage mapping 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. Performance Validation resources have expertise with determining logger placement […]
Read MoreA 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 […]
Read MoreThe 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 […]
Read MoreChallenge 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 […]
Read MoreOverview 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 […]
Read MoreOverview 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. […]
Read MoreOverview 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 […]
Read MoreOverview A small Midwestern drug distribution warehouse needed to demonstrate temperature control throughout storage areas of the warehouse in accordance with USP controlled temperature requirements. Being a small distributor, cost was a major consideration. The Solution Performance Validation (PV) was selected for the project because of their temperature mapping expertise, internal equipment inventory and history […]
Read MoreIncubators/Stability Chambers Performance Validation has extensive experience with incubators and stability chambers 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. Performance Validation resources have expertise with determining logger […]
Read MoreThe Challenge A large international airline company needed to have temperature-controlled storage at two major U.S. airports for the transport and short-term storage of Time and Temperature Sensitive Products (TTSPs). As part of IATA’s (International Air Transport Association’s) certification process, a temperature mapping is required of all temperature controlled storage areas to be used for […]
Read MoreCryogenic Storage/Controlled Rate Freezers Performance Validation has extensive experience with cryogenic storage and controlled rate freezer 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 Kaye Validators and thermocouples. Performance Validation resources have expertise with calibrating thermocouples in and […]
Read MoreAutoclaves/Sterilizers/Steam-in-place (SIP) Performance Validation has extensive autoclave and steam-in-place experience 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 Kaye Validators, thermocouples, self-contained biological indicators (Bis), and BI incubator. Performance Validation resources have expertise with identifying […]
Read MoreThe Challenge A large hospital network planned a significant renovation/expansion to an existing hospital facility located on the south side of Indianapolis. The project included an all new power plant, a new surgery suite, and a six floor patient tower to be phased in around the existing operational facility. The project design adopted energy-efficient solutions […]
Read MoreThe Challenge A medical technology company with no previous Computer System Validation (CSV) experience needed to complete the validation of their Global Shop Solutions (GSS) enterprise resource planning (ERP) computerized system in accordance with 21 CFR 820 (FDA Quality System Regulation) and 21 CFR Part 11 (Electronic Records, Electronic Signatures). The ERP software would be […]
Read MoreThe Challenge: A large Fortune 500 company required Critical Airflow Visualization testing (Smoke Studies) on a new aseptic filling line with active RABS barrier configuration. Additionally, modifications to two existing aseptic filling lines were completed in conjunction with the new filling line. The critical supply chain required completion of airflow visualization in a short window. The video […]
Read MorePerformance Validation has extensive experience with controlled temperature and humidity storage mapping 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. Performance Validation resources have expertise with determining logger placement for mapping, identifying […]
Read MoreThe Challenge: A large Fortune 500 company required Critical Airflow Visualization testing (Smoke Studies) after an upgrade to a high-volume filling line with new RABS barriers. Additionally, there were multiple changes to the layout of the line and room were completed in conjunction with the upgrade. The video evidence of the Critical Airflow Visualization studies […]
Read MoreThe Challenge A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with the qualification of a suite of DeltaV automation modules that support continuous manufacturing facilities around the globe. The suite consisted of 38 DeltaV modules and phases that were interconnected and worked in tandem to automate the continuous manufacturing process. The modules […]
Read MoreOverview A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with the commissioning and qualification of a new portable deblistering machine for use in a pharmaceutical packaging facility. This deblistering machine allows for the recovery of drug products (in tablet or capsule form) from blister cards that have been rejected for issues not […]
Read MoreThe Challenge A client contacted Performance Validation requesting assistance with the commissioning of a pediatric research center renovation project. The research center was to be located within a renovated 2nd floor of an old building that is part of a children’s hospital and was to include exam space for patients participating in clinical research programs as […]
Read MoreThe Challenge A large mid-western Medical Device company responding to multiple FDA inspections had not made adequate progress towards remediating their quality systems. The company had several hundred products that required remediation and a deadline of 18 months to complete this work. The Solution Performance Validation provided a dedicated consultant who participated with the client’s […]
Read MoreThe Challenge: A large manufacturing company required Critical Airflow Visualization testing (Smoke Studies) on two new isolator filling lines and one RABS filling line. The critical supply chain required completion of airflow visualization in a short window. The video evidence of the Critical Airflow Visualization studies are typically reviewed during regulatory inspection and thus must […]
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