A Large Pharma Manufacturer’s CIP
August 9, 2016
A leading manufacturer of life saving and life sustaining products with a 180,000-square-foot plant in Canada manufactures intravenous (IV), nutritional, peritoneal dialysis and hemodialysis solutions. The plastic IV containers, one of the client’s flagship products, are manufactured, filled with solution, and packaged at this facility.
Historically the processes of connecting solution tanks to the container fillers as well as running Clean in Place (CIP) on the filling lines were manual in nature. Operators were required to manually connect pipes and operate valves, making procedures such as supply tank switchover or CIP operations tedious, erroneous and expensive. This prompted the “Dry Facility Automation System” project which is a multi-million dollar initiative aimed at automating the IV manufacturing facility.
The Dry Facility Automation System project was a complete overhaul of the pre-existing fillers supply and CIP system. It included an update to all of the process piping to support better drainage capability, add product recirculation functionality and allow for automated connection of multiple tanks to multiple filling lines. It also encompassed a new, comprehensive fleet of instruments that help regulate and monitor solution flow including automatic solenoid valves, GEA Tuchenhagen mix-proof valves, analog control valves, back pressure valves, Endress and Hauser mass and magnetic flow meters, pumps and variable frequency drives.
The facility consists of three filling lines serving 2 automated fillers and 3 manual fillers. These lines are fed by 13 solution tanks that are to automatically connect to the filler assigned by the operator.
The project can be divided into two main disciplines: Process Engineering and Automation Engineering. Process engineering involved the design and implementation of the piping system, the valve skid as well as specifying what devices to energize at what operation phases of the system to achieve the desired flow path. Automation Engineering involved interfacing to the equipment, building utilities, mixing room, and bringing the design specifications to life in the form of PLC and HMI systems for operator interfacing.
At the time of Grantek’s involvement the project had already been in execution for over 1.5 years. Grantek’s process engineering partner was contracted with the Process aspects of the project. The Automation aspects were handled firstly by a third party systems integrator and then handed off to the client’s in house automation specialists.
The client was facing serious challenges on the Automation side of the project. The company was frustrated with the development efforts for the smallest and least complex line. The project had overruns on both the schedule and budget. Despite clear specification documents , the system kept failing to perform as expected and new errors were discovered each time validation tests were attempted. The new PLC was starting to fill up with on the fly patches and hot fixes which only introduced more errors. The in house specialists were starting to get overwhelmed by tackling this large project alongside responding to daily production activities. The project seemed to hit a brick wall and our client realized that it cannot continue on its current course.
The client turned to Grantek’s expertise in process automation to revive the project in October 2014. In order to take advantage of an upcoming shutdown, the client was hoping to make a dent into the project. Grantek was tasked to tackle the most complex line with 3 fillers and multiple tank batching in less than 3 months.
Fortunately, Grantek delivered; and by early January 2015 the most complex line ran through two rounds of validation successfully, a state that the initially started simple filling line failed to achieve in over a year.
Grantek faced the challenge of having to write the PLC code in this short time span. The ControlLogix PLC program that already included logic from the existing line and was to be amended with the new line logic. Each of the three fillers of the complex line consisted of a PLC program and HMI application, to which CIP functionality was to be added. The fillers were a mix of ControlLogix and PLC5 and the HMIs consisted of PanelViews. The CIP PLC was to keep its interface to the in-house developed Vijeo Citect HMI.
To tackle the task Grantek put together a strong team with diverse expertise. The team focused on overall design and significant thought was put at the start of development into how to make the code efficient, reliable and clean. Rather than each developer embarking on their own paths a standard base was jointly developed and agreed upon; resulting in a unified, easy to follow system.
Grantek took advantage of reusable and reliable Add-On Instructions (AOIs). Grantek employed its own phase engine AOI, which has been developed over many years and had a proven record of success. Grantek also integrated Rockwell Automation’s latest PlantPAX AOIs, a group of configurable functions that control process related modules and devices with proven reliability, to drive the different instruments in the system. The use of these templates built an abstraction layer and allowed Grantek to focus its development efforts on higher level, custom logic while relying on a strong basis.
Another factor that improved development efficiency and helped Grantek meet its strict target was code auto-generation. After perfecting the routine that controls one valve Grantek wrote and utilized auto-generation scripts to produce the logic for the over 50 remaining valves. Similarly, templates were used to auto-generate similar phases. This significantly reduce development time and also ensured that no repeatability or copy-paste errors were induced.
The above mentioned methodologies were factors of what made the project the success it was, but at the heart of it all lies Grantek’s experienced and dedicated staff. Grantek provided 24 hour on site coverage throughout the plant’s winter shutdown where the line ran through dry and wet validation testing. Due to Grantek’s detail-oriented development efforts the validation process was quite smooth encountering minor nuances that were quickly and effectively dealt with. By the end of winter shutdown, the line was commissioned successfully.
Entering the Dry Facility Automation System project at a late stage Grantek quickly exceeded expectations and put the project back on track. The client still relies on Grantek to bring the whole project to completion, including the remaining filling line and possibly reworking the first filling line. Grantek proved that it can bring real quality to the project and quickly turn its course to success.