Qualification of Continuous Manufacturing Suite

Continuous Manufacturing Process Train Qualification

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.… more

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.… more

Non-Destructive Leak Test

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.… more

Building Management System

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A leading pharmaceutical packaging company planned to migrate their outdated Building Management System hardware which controlled and monitored their freezers, coolers and packaging suites to their existing BMS system.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. … more

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

Automated Product Storage and Retrieval System

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 as well as reduce risk for human error when handling the product on fork trucks.… 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

QC Lab

Animal Health Manufacturing Facility – QC Lab Construction

The Challenge

Based on inefficiencies in operation and maintenance costs, a large Midwestern Animal Health manufacturing company decided to move its Quality Control, Technical Services, and Cell Culture laboratory (QC Lab) operations from the existing facility — an administrative building retrofitted to be used as a QC Lab many years ago — to a new state of the art QC Lab facility.… more

Data Management System

The Challenge

A Midwestern pharmaceutical company planned to add a data management system with archiving, retrieving, and reporting capabilities that managed facility data.

The Solution

Validation Planning- Pefrormance Validation (PV) developed the Validation Plan and User Requirement Specification for the data management system. … more

Facility Renovation for New API

The Challenge

A leading manufacturer of over-the-counter store brand pharmaceutical products underwent a facility renovation for a new product line.  In order to safely manufacture and regulate the new active pharmaceutical ingredient (API), a reconfiguration of utilities including HVAC, dust collection, purified water, compressed air, and nitrogen was required.… more