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 […]

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Dry Product Packaging Line Qualification

The 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 […]

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Cell Culture Purification Suite Qualification

The 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 […]

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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.  The project was part of a pilot project delivery method and involved adapting an […]

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Blister Card Packaging Line Qualification

The 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 […]

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Non-Destructive Leak Tester Qualification

The 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 […]

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DNA Based Diagnostic Project

The 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 […]

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Capacity Expansion at an Animal Health Facility

The 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 […]

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Building Management System Validation

The 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. […]

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Legacy ERP Validation Project Summary

The 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. […]

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