Finished Drug Product Distribution Warehouse Commissioning

The 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. … more


Validation of Ignition SCADA (Inductive Automation) System for Medical Device Assembly

A leading medical device manufacturer introduced a new production line to their assembly facility.  The new line was designed to accommodate the simultaneous production of several makes and models of hand-held motor-driven surgical devices.  This new line was designed to apply the latest integrated manufacturing technology to optimize flexibility, efficiency, quality controls, and real-time accountability toward meeting immediate market demand for product.  … more


Medical Device Programming System Validation

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 motorized surgical devices.more


FMEA Training

The Challenge

A biomedical research company sought to increase worker knowledge in the use and application of the Failure Mode Effects Analysis (FMEA) quality tool.  The company desired a pragmatic approach with a combination of theoretical understanding of how the tool might be used, and a practical application of the use of the tool with one or more current products.… more


Project Summary – SCADA Validation for Medical Device Assembly

A 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 of their manual assembly operations.… more


Ultrasound Validation Project Summary

The Challenge:

A contract research organization (CRO) contracted Performance Validation (PV) to create a Computer System Validation (CSV) package for an ultrasound instrument.  They use the system during surgery to perform analysis flow, stress, wall thickness and detect blockage.  The instrument and its data acquisition/analysis software was purchased to replace an aging ultrasound system that was no longer being supported. … more


Manual 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 was needed.… more