Eli Lilly: Invited Back to Streamline an Insulin Process, CSA Delivers Again

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Initial Configuration: Making a Good First Impression

Back in 2002, the rising number of people living with diabetes was increasing the global demand for injectable insulin. To meet this growing need, Eli Lilly built a brand new facility in Puerto Rico to manufacture insulin in bulk quantity. CSA came in as a key member of the design and automation team that configured the new facility’s Emerson DeltaV control system.

We were in charge of multiple large process cells in the purification and utilities process areas, and we were instrumental in designing the S88 batch control strategy. Overall, we handled 33% of the software configuration and validation. And we stood by Eli Lilly for over two years on-site, supporting their qualification process.

The facility was launched successfully and started reliably producing the bulk quantities of injectable insulin that people with diabetes needed. The quality of our work and our investment in the project’s success were noticed and not forgotten.

Streamlining the Process: Quality Remembered and Delivered Again

Twelve years later, Eli Lilly wanted to reduce process steps at the facility in order to streamline their purification process. They remembered us and asked us back.

There are few challenges we find as satisfying as optimizing a process, so we were very pleased to take on the job.

After a thorough audit, we re-coded and validated the DeltaV software for all process cells. We were responsible for 90% of the re-coding effort, including the clean-in-place (CIP) process. We achieved a dramatic reduction in process steps, and we even delivered the automation services under budget.

We’re pretty sure we made a second impression at least as good as our first.

Services Provided (Initial Configuration):

  • Continuous and batch configuration of DeltaV system
  • Instrumental in the overall S88 batch design strategy for the entire system.
  • Operator display development
  • Simulation for testing and for checkout
  • Detailed design specifications and validation test protocols for FAT/SAT
  • Conventional I/O, Foundation Fieldbus, DeviceNet
  • Loop tuning
  • On-site IQ/OQ testing
  • Control System: Emerson DeltaV

Services Provided (Streamlining Project):

  • Supplied DeltaV automation team of engineers for the recoding of the purification/CIP process. The system was a large-scale DeltaV Batch system consisting of several hundred batch units.
  • Used MIMIC to simulate the entire DeltaV system.
  • Sponsored SFAT’s using WebEx meetings with customers in Puerto Rico to reduce project cost.
  • Organized and provided full support of the onsite fix team. The fix team was responsible for coding corrections on the DeltaV qualification system.
  • Supported onsite Form 0’s (water batching) and OQ’s for all process cells. We provided onsite support for more than one year.

Johnson & Johnson: Inox Dryer Optimization

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Johnson & Johnson wanted to improve the operability of their Inox dryers with a control system that offered better control and flexibility. So they called on CSA to optimize their existing RS3 to Allen Bradley PLC5 interface.

We did a total rewrite of their PLC ladder logic code, using S88 principles to organize the PLC code into control modules and equipment modules. These modules interacted directly with corresponding RS3 templates. This made operational control of the dryers intuitive and better integrated into the DCS system.

We also historized all dryer critical parameters, and we integrated all alarms and interlocks into the DCS system for operator view and action. Before this project, operations personnel had to enter a restricted clean area to diagnose system alarms and failures. After the project, operational personnel could control the dryers in exactly the same manner as RS3 controlled I/O.

The new interface also allowed simple integration into the RS3 Batch system. The Batch system simply commanded the equipment modules using state control rather than the primitive ladder logic control of the equipment.

As requested, our work gave Johnson & Johnson much better control and flexibility for their dryers, enhancing their operability. They were very pleased with the results.

Services Provided:

  • 100% conversion of over 1,000 lines of poorly written ladder logic to control modules and equipment modules (S88) design
  • Configuration of RS3 graphics, faceplates and details
  • FRS development for PLC
  • Panelview 1400 configuration for local dryer control based on mode control
  • SFAT test plan and supporting test protocol development
  • SFAT support services
  • IQ test plan and supporting test protocol development
  • Onsite IQ and OQ support
  • Control System: PLC5’s and RS3 DCS system

Baxter Healthcare: A Tale of Two DeltaV Migrations

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Baxter Healthcare had two plants with control systems running versions of DeltaV that were very outdated. One plant was running version 7.3 and the other 8.3. Baxter wanted them both upgraded to version 11.3. However, direct migration to 11.3 was not supported for either of the outdated versions, so they called in CSA to find a way.

Because direct migration to the current version of DeltaV was not allowed, we decided to use virtualization (virtual computers) to migrate the system in steps along approved vendor migration paths.

First, we wrote a detailed migration procedure and reviewed it with Baxter’s quality department, making sure we were prepared to deliver a seamless migration.

We then deployed a test system onsite, using newer system computers that were DeltaV 11.3 compatible. We also created 150 qualification protocols to ensure that existing control modules would migrate successfully.

Using virtualization, we took the 8.3 system to 8.4.2 to 10.3 and from there to version 11.3. And we took the 7.3 system to 7.4.1 to 7.4.2 to 9.3 and then to version 11.3. We also used virtualization to migrate DeltaV server machines to include the ProPlus, Batch Executive, Batch Historian, and PI Legacy Historian (App Station).

We then imported the migrated code into the new test systems and tested them extensively. When the new systems were fully operational, the test systems took over as the new production systems, and we retired the old systems.

Our virtualization method was a great success, and the migrations went very smoothly. Baxter was delighted.

Services Provided:

  • Developed detailed written migration procedure which was reviewed and approved by the site quality department
  • Provided DeltaV Hardware for version 11.3. All of the control system computers were replaced with newer models.
  • Deployed test system into production area. Old system was retired and test system became production system.
  • Executed migration procedure with customer representatives from automation and quality as witnesses and sign-off
  • Setup test DeltaV system onsite at version 11.3
  • Imported migrated code to new system and provided qualification support during qualification period
  • Created 150 qualification protocols to ensure control modules migrated successfully to 11.3 with no issues
  • Control System: DeltaV

 

Baxter Healthcare: Desflurane Plant Expansion

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Baxter Healthcare wanted to increase production of desflurane at their Puerto Rican facility in order to meet global market demand for this popular surgical anesthetic. Quality control was, of course, just as important as making a swift transition to higher productivity, so Fluor Caribbean subcontracted CSA.

We were brought in to make the necessary modifications and additional configurations to Baxter’s existing control system software. We wrote the new FRS and developed the SFAT, IQ, and supporting test protocol plans. We configured control and equipment modules, and conventional, Foundation Fieldbus, and DeviceNet I/O types. Then we supported SFAT and onsite IQ/OQ/PQ validation.

The expansion went well, and Baxter was soon able to meet the growing demand for desflurane.

Services Provided:

  • Configuration of control and equipment modules
  • Configuration of conventional, Foundation Fieldbus, and DeviceNet I/O types
  • Operator display development
  • FRS development
  • SFAT test plan and supporting test protocol development
  • SFAT support services
  • IQ test plan and supporting test protocol development
  • Onsite IQ/OQ/PQ validation support
  • Control System: Emerson DeltaV

Baxter Healthcare: Sevoflurane Plant Expansion

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Baxter Healthcare wanted to increase the capacity of an existing pharmaceutical manufacturing facility. The plant produces sevoflurane, an inhaled anesthetic particularly popular in pediatric surgery. Quality control was imperative, and high demand meant there was no room for time-consuming mistakes. It was just the kind of project we most enjoy.

CSA converted the facility’s existing DeltaV 5.2 configuration to 8.3, and created the new configuration for the expansion, carefully validating all configuration templates. We also wrote new FRS and IQ validation documentation for the expanded plant.

To support the new configuration, we developed several new control and equipment modules, all of them created, documented, and validated in accordance with GAMP4 guidelines. And though the modules were not part of the original project scope, we kept the project on schedule.

Prior to hardware and software factory acceptance testing (HFAT/SFAT), we bench-tested all new Fieldbus, ASi, and DeviceNet field instruments in an integrated test environment. We then managed HFAT/SFAT and executed the IQ protocols on-site prior to startup.

We completed the commission in record time, with no schedule delays and no surprises. The customer was, of course, delighted.

Services Provided:

  • Configuration of control and equipment modules
  • Configuration of conventional, Foundation Fieldbus, ASi, and DeviceNet I/O types
  • Operator display development
  • FRS development
  • HFAT test plan and test protocol development
  • SFAT test plan and test protocol development
  • IQ test plan and test protocol development
  • Design of control panels, control room operator console, DeltaV network
  • Procurement and installation of DeltaV control panels, DeltaV workstations and Ethernet network, and control room operator console
  • HFAT/SFAT support services
  • Loop tuning and process optimization services
  • Startup and validation services
  • Control System: Emerson DeltaV