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.
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:
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About Performance Validation: Performance Validation is a 100% employee-owned company has been serving the life science industries since 1988, and is a nationwide leader in providing validation, commissioning, and quality services for pharmaceutical, biotechnology, and medical device manufacturers.
We are not a virtual company, a staffing agency, or a “body shop.” Our projects are managed and staffed by our own employees. We live by our Mission, which is to provide our clients with peace of mind, and we have been doing so for more than 30 years.
For more information:
Vice President, Indiana Division Director
Performance Validation, Inc
Office: (317) 248-8848
Cell: (317) 727-8495