API Manufacturer Engages Experienced Automation Integrator at the Conceptual Design Stage to Accelerate Time to Market


Specify, design, develop, commission and validate a robust, supportable, expandable and sustainable supervisory control system for a new API; Active Pharmaceutical Ingredients; process line that had previously only been defined in concept at a high level. The new line consisted of re-purposed existing process units, new process skids and a new CIP / SIP System. Operational or functional details were ‘to be determined.


An aggressive “Time to Market” schedule was this project’s primary driver. Very little had been previously defined by the client other than the fundamental process units required to make the new API. No P&IDs nor other documentation existed as this was very much a “design and build as you go” project.

Initially capital was available to incorporate the new process equipment and controls; however, no funds were available to replace the legacy control system. The initial solution would have required cross communications between the control system for the new process units and the legacy control system for the existing process units.

Since this was a new API being scaled up for production, the team anticipated changes to the design as the project progressed.

The programming of the control system and generating the associated validation documents occurred as parallel efforts due to the aggressive project schedule with little time and limited resource availability to bring the detailed design and get the drawings and documentation to a “Revision 0”.


Malisko deployed a team of resources experienced in specification and design of instrumentation, controls, operator interface, networks, security, electronic records and computer system validation for pharmaceuticals and API’s

Due to the aggressive project schedule, I/O panels needed to be designed and built before final I/O counts were determined. P&IDs of a similar line were marked up to get an estimate of I/O type and count requirements so panels could be designed and built. We then worked with the client’s project team to better define the I/O list by reviewing and then recommending end point control devices to best fit the control scheme.

The system consisted of one main I/O panel, multiple Rockwell ControlLogix processors and solenoid panels physically located throughout the process space to minimize distances between the control valves and the solenoid panels. Three new operator stations were added to the production floor along with a new historian and Rockwell VantagePoint reporting server.

The plant’s project team developed a high-level concept for the process. We then took that concept, evaluated several methods to best control the process, then proposed a flexible and secure solution. Evaluations included a batch engine, Sequential Function Chart programming and an Out-of-the Box step sequencing solution (Rockwell’s PlantPAx Library of Process Objects P_Seq object). We determined that the P_Seq Object provided the flexibility needed and required no custom code to be added to the controller. This control platform accelerated the system development, testing and deployment. The control system architecture gave the plant team the flexibility needed to make changes to the process as needed while the client conducted product trials.

All control programming code was developed utilizing Rockwell’s Library of Process Objects, thus giving our development team the needed structure, flexibility and nimbleness as the process design changed. In addition, the creation of validation documents and procedures was streamlined by leveraging the vast amount of documentation already existing for the Rockwell Library of Process objects along with its standard global objects within the system.

Routine and frequent design and code reviews of the automation system were conducted with the plant’s project team to assure alignment between the process needs and the control system implementation.

Design documents were developed keeping in mind the format and content of the corresponding computer system validation documents. The project gained significant time and cost savings by utilizing Malisko’s methods and templates for validation-related documents.

Validation documents; IQ and OQ protocols; were used as the “checkout” documents during the FAT and on-site engineering testing prior to “locking down” the validation documents. Better alignment with the system requirements was achieved along with ultimately reducing the number of deviations during the actual on-site IQ and OQ protocol execution.


The client met their intended schedule for producing the new API. The client eventually realized that the project’s magnitude and complexity was far greater than they initially anticipated. The client, however, relied heavily on the project management, execution, deployment and computer system validation experience of Malisko to bring the project to a successful conclusion. The automation system works well. The operators have a good grasp on the PlantPAx platform and understand how to interact with the system. They like the high-performance graphical user interface we deployed. The client now uses this implementation of controls and graphics as their process automation platform standard.

The client’s engineering team was very impressed with the variety of features and process notifications of the operator station’s faceplates for valves, pumps, instrumentation, setpoint manipulation and process control loops. The client utilizes Historian and VantagePoint reporting systems to track and verify their process as well as use them as a troubleshooting tool when needed.

Overall, the project seemed to push the client into the present-day application of process automation. Furthermore, the client is now evaluating their other process control systems, which are very manual, and are looking to add this standardized platform of process automation to further enhance their other production systems.

The client has been very happy with Malisko as an automation integrator due to our expertise in the field. Because of this knowledge base, they continue to ask for our opinions and suggestions going forward. They acknowledge that this project had numerous challenges from the get-go and they have been very impressed with our flexibility, can-do attitude and ability to provide good work within the required time frame and at an investment cost meeting their objectives and constraints.


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