Automated Storage & Retrieval System (ASRS) Qualification

Cold storage

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

Bio tech

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 Construction


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

Information systems

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

Automated Inspection

device assembly equipment.

Combination Product Inspection Facility – Automated, Semi-Automated and Manual Inspection

The Challenge

A large Midwestern pharmaceutical company planned to build a new facility dedicated to inspection of finished cartridges and syringes for use in an injection pen (a combination product). This facility would centralize inspection processes and also provide new automated inspection capabilities in addition to semi-automated and manual inspection.… more

Capacity Expansion at an Animal Health Facility

Food Processing

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 optimization, a sustainability option.… more

Freeze Dryer Upgrades

freeze dryers

The Challenge

A large mid-western pharmaceutical company planned to add feedback to the primary pins on its suite of eight freeze dryers already in use.  Significant constraints existed on the schedule because a facility shutdown was required to integrate feedback of the primary pins into the programming and multiple other projects were being implemented in parallel on the equipment. … more

Tablet Press Automation Qualification

Tablet Press

The 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.… more

API Verification Support

PI Manufacturing Verification Support


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.   … more