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. Two of the notable challenges on this project were that the AS/RS vendor did not have previous Pharma Industry experience, and that qualification of the system faced a shutdown driven “hard-date” for completion to accommodate product transfer from a another qualified chilled storage space.

The Solution

To ensure success, a commissioning and qualification (C&Q) plan was developed to ensure all functionality was tested thoroughly. This testing limited potential down time or product damage due to equipment failures. Performance Validation worked with the client and the AS/RS vendor to assist in defining the scope, determining user requirements, and developing testing for user and functional requirements. The following activities were implemented to maximize project success.

  • Performance Validation (PV) assisted in extensive engineering shakedown activities.  All test cases were dry ran to verify the system functioned as expected.  The PV team developed an expertise with the AS/RS system, such that when issues arose, PV staff were instrumental in investigation, root-cause analysis, and determination of solutions.
  • Performance Validation helped to develop a realistic C&Q schedule to maximize shakedown time.  Maximizing this shakedown window helped give peace of mind that the equipment would operate correctly during and after qualification.

The Results

The automated product storage and retrieval system was successfully installed and qualified in accordance with the project schedule, which allowed a seamless product storage transition to the newly qualified space.


Performance Validation coordinated with multiple stakeholders to successfully complete qualification of the AS/RS to meet an aggressive schedule. An extensive engineering shakedown process allowed for an expedited qualification period, with minimal testing issues. The client now has a validated state-of-the-art Automated Product Storage and Retrieval System, which is serving as a model for advances in storage and retrieval efficiency across the organization.

For more information, please schedule a call with one of our subject matter experts. 

Brad Henry
Vice President & Division Director, Indiana
Performance Validation, LLC.

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