A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with the qualification of a suite of DeltaV automation modules that support continuous manufacturing facilities around the globe. The suite consisted of 38 DeltaV modules and phases that were interconnected and worked in tandem to automate the continuous manufacturing process. The modules needed to be fully qualified within a period of 6 months in order to meet a regulatory commitment.
The automation suite controlled all the equipment and processes involved in the continuous manufacturing process. This includes manufacturing equipment (feeders, mixer, tablet press, label printers, etc.), quality control equipment (composition analyzers, automated tablet tester, reject control systems, automated sampling systems, etc.), and integration with supporting computer systems (batch management software, equipment specific software, etc.).
Performance Validation provided validation engineering resources to aid in the development and execution of the testing for the automation suite, as well as provide a lifecycle approach for documentation.
The same modules could be used at multiple continuous manufacturing sites worldwide (because each site utilized a similar process train); therefore, the validation approach was configured in a way to minimize the amount of testing required at each site. Rather than developing testing that would need to be repeated at each site, Performance Validation worked with a centralized group to develop and execute testing that was focused on the modules and their interactions. The modules were then sent to each site, where site-specific testing (such as configuration verification) was performed. This approach allowed the sites to take credit for the “centralized” testing and reduce the amount of testing needed at each site.
- Validation & Test Plan: Revised existing validation and test plan to streamline testing and approval process.
- Unit Level Testing (ULT): Developed and executed ULT test cases to verify the proper design of each module.
- System Level Testing (SLT): Developed and executed SLT test cases to verify the proper functionality of each module.
- Test Summary Reports: Created reports summarizing the testing, issues encountered, and validation status of each module.
- Release Notes: Created reports for the manufacturing sites indicating installation/upgrade instructions, appropriate documentation references, lists of all files needed, and any additional testing required on site. These reports were sent to each manufacturing site that used the module(s), in order to allow for a seamless and efficient transition.
The automation suite was fully tested and qualified one month in advance of the deadline. This enabled the company to implement and use the automation suite for continuous manufacturing at multiple sites earlier than expected.
The following are some of the benefits obtained from this project:
- The automation suite was completely qualified one month ahead of schedule, which enabled earlier than expected testing and production at the client sites.
- The amount of repeat testing was minimized due to the structure of the validation plan.
- High quality and consistent documentation was used to satisfy a regulatory commitment.
We turn critical into compliant.
Since 1998, Performance Validation has been providing clients with expertise in the commissioning, qualification and validation services areas in the life science industries. Our team thrives on the importance of quality, integrity and teamwork, giving our clients peace of mind during every step of the project.
Because PV is a 100% employee-owned company, we choose our work family very carefully, so our clients are confident they are getting the best.
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For more information:
Vice President, Indiana Division Director
Performance Validation, Inc