The Challenge

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.).

The Solution

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 Results

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 Benefits

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.

Have a question on DeltaV automation modules? If so, please contact us using use our Contact Us form and one of Performance Validation’s team will be in touch.
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:
Brad Henry
Vice President, Indiana Division Director
Performance Validation, Inc
Office: (317) 248-8848
Cell: (317) 727-8495