The Challenge

Performance Validation frequently executes projects that include a Factory Acceptance Testing (FAT) component of project work. These projects are completed with multiple clients, across both Pharmaceutical and Medical Device life science industries.  Each of these project FATs required a different level of support, but all required thorough coordination and communication with equipment manufacturer, the end user, and Performance Validation.

The Solution

Below are summaries of a few of the FAT efforts Performance Validation has assisted with.  These examples illustrate how PV assisted our clients to ensure Good Documentation Practices were followed, testing developed and executed following cGMPs, to help ensure a successful FAT:

Potent Nasal Spray Filler FAT (MINNEAPOLIS MN):

Performance Validation worked with the stake holders to determine what critical and non-critical items needed to be tested/verified during the 2-week FAT. Performance Validation generated the FAT document.  Document was reviewed and approved by the client’s quality department and executed by Performance Validation with assistance from client and equipment manufacturer Subject Matter Experts (SMEs).  PV created and managed a master FAT punch-list. Testing completed during FAT will be leveraged to reduce the amount of on-site testing required after final installation of the filler.

Stainless Steel Processing Vessels (Springfield MO):

Performance Validation collaborated with the vessel manufacturer to develop a thorough and complete FAT document.  PV was able to instruct the vessel manufacturer on the specific documentation and testing requirements needed by the client.  This collaboration led to a very well developed Turn-Over Package that contained all of the necessary documentation.  Also, this collaboration allowed the equipment manufacturer to be fully prepared to facilitate the necessary factory testing.  As a result, 5 tanks were checked out and approved for delivery in just 3 days.  Performance Validation was able to utilize qualified resources close to the FAT to reduce travel costs.

Aseptic Transfer Cart (Villach Austria):

Performance Validation Project Leader served as GMP documentation SME and helped to ensure that FAT documentation was completed satisfactorily to be leveraged for final qualification.  PV also performed a Vendor Certification of the equipment manufacturer while on-site.  PV also helped the equipment manufacturer setup and execute critical airflow visualization in a method consistent with the clients requirements for airflow visualization.  For this FAT, PV generated and managed the master FAT punchlist.

Solvent Recovery Column (Allentown PA):

Performance Validation reviewed and approved the FAT document and ensured that the client’s quality and engineering reviewers agreed on FAT strategy.  FAT execution consisted of MOC verification, P&ID field verification, and Instruments and Controls Installation and Functional Verification.  For this FAT, PV generated and managed the master FAT punchlist.  PV acted as GMP documentation SME and helped to ensure that FAT documentation was completed satisfactorily to be leveraged for final qualification.  This FAT was successfully completed and the testing performed allowed for much faster final qualification and release into production.

Compounding and CIP Skids (Fort Atkinson, WI)

Performance Validation collaborated with the skid manufacturer to develop a comprehensive FAT protocol testing all installation features and operational requirements.  The PV team led the execution of the FAT protocol with minimal client assistance, and was responsible for generation and tracking of the FAT punchlist.  The extensive documentation review performed during FAT allowed the documentation portion of Installation Qualification to be completed in minimal time, and the comprehensive functional testing brought to light a host of design and programming errors that were able to resolved prior to shipping the skids to the client site.

Glucose Test Strip Processing Equipment (New Castle, IN)

Performance Validation led the development and execution of FAT testing for a series of glucose test strip processing equipment.  This equipment’s function was to cut 1000m rolls of test strips into individual strips and place them into vials for patient use.  The equipment was built-to-print based on previously validated equipment.  As such, the FAT protocol was pre-approved by the client’s Validation Review Board, including Quality Assurance, and was able to be highly leveraged toward Qualification testing.  This allowed for on-site qualification testing to be completed in a manner of weeks vs. months compared to the first generation equipment.

Air Handling Units for Parenteral Manufacturing Facility (Lynchburg, VA)

Developed, executed and summarized an FAT protocol for a new air handling unit for a parenteral facility.  Testing included verification of the critical construction features of the AHU unit (i.e. dimensions, component models/sizes, etc.), airflow testing, fan motor vibration testing, and verification of vendor and component IOM and testing documentation.  The FAT visit completed with a punchlist for the vendor to complete/fix prior to shipping the unit.  The FAT was summarized and post-approved upon verification of punch-list completion.

Non-Sterile Liquid Line (Unscrambler, Filler, Capper) FAT (Montreal Canada):

Performance Validation developed the FAT documents for the 3 pieces of equipment that comprised this filling line: bottle unscrambler, cream filler, and bottle capper.  The FAT was divided into 2 weeks: first week for initial check-out and punch-list development and the second week for integrated Functional Verification.  The Functional Verification tested not only the performance of each individual piece of equipment but also tested the entire line as a system.  By performing and documenting the FAT with Good Documentation Practices the FAT document was directly leveraged against verification efforts on-site.  PV was able to help the equipment manufacturer understand the client’s specific needs for the equipment, which lead to better build quality and greater piece-of-mind for the client.

Summary and Benefits:

In summary, Performance Validation has supported a wide range of Factory Acceptance Testing (FAT) for a broad range of equipment types all across the United States, Canada, and Europe.  PV helps our clients develop and execute thorough FAT documents which lead to faster acceptance, reduced final commissioning and qualification efforts, and faster implementation into production.  PV has the experience and expertise to support the Factory Acceptance needs of the regulated life science industry.

For additional information on how Performance Validation may help improve your FAT experience, please schedule a call with one of our subject matter experts.

Brad Henry, Indiana Division Director, Vice-President Performance Validation, LLC

John Underwood, Michigan Division Director, Performance Validation, LLC

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