Top Plant 2012: Pfizer Global Supply

An Rx for manufacturing success: Focus on safety, quality, and uptime is the right prescription for progress at Pfizer.
By Jack Smith December 17, 2012

High-profile companies are continually in the spotlight. Expectations of greatness accompany this attention.

One manufacturer that is no stranger to the limelight is Pfizer Inc. Pfizer Global Supply’s Kalamazoo, Mich. plant, the 2012 Plant Engineering Top Plant winner, manufactures injectable medications, liquid and ointment, and medical device products for humans and animals.

“The Kalamazoo site has always been very aware of safety and quality, but to achieve these levels of success has required continued focus throughout the entire organization,” said Frank Foley, plant manager at the Pfizer plant in Kalamazoo. “All colleagues have to understand that this is a priority for us and part of what we do. These are not optional extras. Only then can you achieve these results in safety, quality, and uptime. This involvement also includes participation in various site-wide programs and recognition celebrations. It’s a race without a finish line.”

Reducing energy use, costs

Each Pfizer facility actively engages in energy management programs. At the Kalamazoo plant a dedicated multidepartment team, which consists of engineering, maintenance, production, environmental, and utility personnel, looks for opportunities for energy savings, greenhouse emission reductions, and conservation projects.

Since 2004, the plant has installed more than 200 energy conservation projects, saving more than 188,000 MWh of electrical power annually. These efforts included facility lighting upgrades, water conservation projects, condensate return improvements, and installing variable frequency drives on numerous pumping systems and HVAC units.

An operator in the required PPE works on one of the container filling lines at the Pfizer Global Supply plant in Kalamazoo, Mich. Courtesy: Pfizer Global SupplyIn 2010, the Kalamazoo facility received recognition and praise from Pfizer corporate headquarters for its lighting upgrades. “We replaced metal halide fixtures, high-pressure sodium fixtures, and T12 fluorescent with linear fluorescent T8 lamps and electronic ballasts,” said Jim Taylor, energy manager at the plant. “Most areas of the plant run 24/7, so, where possible, we installed occupancy sensors or timers. This is especially effective in warehouses, office space, mechanical rooms, and production areas that do not operate 24/7. We did the upgrade in one big sweep. It took us about three years.”

The savings are significant. Taylor said the annual energy decrease is more than 23,000 MWh. The fluorescent T8 lamps provide higher lumen output and better lumen maintenance, and they provide the opportunity to switch lights on and off based on occupancy, he said.

The Kalamazoo plant’s water conservation projects include process-water control-automation improvements, condensate return line replacements, and HVAC retrocommissioning. The average annual water consumption decrease is more than 2,000,000 cubic meters.

Robots insert formulated product materials into trays in the drug product plant. Robotics play a key role in plant operations. Courtesy: Pfizer Global SupplyThe energy management system installed at the plant in 2009 monitors utilities and provides data to the utility historian. In addition to displaying data in real time on the plant’s Web-based energy dashboard, the facility has more than three years of data archived within the utility historian.

“We created internal Web pages where we can view and trend every utility meter on campus,” Taylor said. “Anyone on-site can look at this tool. Operators can see immediately how their processes affect energy usage.”

As with many facilities, one of the Kalamazoo plant’s major challenges is to continue to identify and act upon energy-saving opportunities with limited resources.

Operations, continuous improvement

Pharmaceutical raw materials are produced in the Kalamazoo facility’s active pharmaceutical ingredient (APl) plant in preparation for formulation in the drug product (DP) plant. API processes include fermentation, isolation, and chemical synthesis. The Capped vials are inspected, labeled and packaged before shipping, as part of the rigorous requirements in the Pfizer plant. Courtesy: Pfizer Global Supplytypes of equipment used in the API plant are similar to those used in a typical chemical plant: pressure vessels, heat exchangers, piping systems, and water filtration devices. Equipment used in the DP plant includes container filling lines, freeze-dry operation, packaging machines cartoners, and palletizers.

Product flow generally begins with materials made in the API plant and ending in the DP plant for formulation. After formulation, vials or bottles are processed through the various filling areas, with some being freeze-dried, and are ultimately capped. The capped vials are inspected, after which they are labeled, packaged, and shipped.

“This plant is diverse,” said Jason Cassiday, senior manager, operational excellence. “The batch processes in our plant are very similar to what you’d find in a chemical plant. We also have typical production lines where we fill bottles and vials.”

Many manufacturers, including leaders in the pharmaceutical industry, seek ways to make more product in less time with less effort. “We analyze batch processes to look for opportunities to move them along faster, or even for technology advances that we could implement to enable us to run more efficiently and effectively,” Cassiday said. “The way we apply Lean principles is a little different, depending on where you are. On the batch side of the plant, the demand exceeds our current capacity. We are challenged to try to unlock capacity in our equipment. To do that, we need to identify where the waste is, and that’s what Lean is all about.”

Experienced operators analyze batch processes to look for opportunities to move them along faster. Courtesy: Pfizer Global SupplyIdentifying waste requires breaking down the processes step by step. “The key for us is to work with the operators who run the processes,” said Cassiday, “and present them with the data in a way that makes it easy to see where an issue might be, and to ask them for their input for what we could do to run more effectively. This has been a major objective in that part of our plant for the last two years. And we’ve seen tremendous gains in our throughput.”

By implementing efficiency improvements, the Kalamazoo plant was able to free up capacity equivalent to two work centers. “That’s two workstations we don’t have to purchase because we found ways to optimize what we had,” Cassiday said. “It was all because we worked with the people who work with the equipment every day.”

Engaging, empowering employees

The efficiency improvement focus at the Kalamazoo facility entailed “teaching people how to fish.” Cassiday calls it area transformations. “Our operational excellence group facilitated multiweek sessions with the operators to teach them,” said Cassiday. “Instead of us analyzing equipment capabilities and waste, we taught them the basics of continuous improvement. It was all about getting them to do it themselves.

The operators worked through exercises to determine their strengths and discover opportunities for improvement—the results of which typically translate into cost, quality, and supply: the basics of manufacturing. For example, if operators know their yields, they can discover ways to improve them. It’s all about engaging the operators,” Cassiday said.

Ownership and empowerment can go a long way to help foster engagement. Employee engagement was one of the ideas behind the energy dashboard. “They see waste every day,” said Taylor. “We did an awareness campaign to make sure the energy dashboard tool touched as many people as possible, especially at the operator level, because they’re the ones with the energy savings ideas.”

Maintaining equipment, processes

Robotic sorting is another automated task performed in the Pfizer plant in Kalamazoo. Courtesy: Pfizer Global SupplyThe maintenance strategy at the Kalamazoo plant site is based on reliability principles and standard workflow processes. The program includes streamlined preventive and predictive maintenance activities, process safety management/mechanical integrity processes, lubrication, operator care, PM optimization, and root cause failure analysis processes.

A team of highly skilled journeyman-level technicians and certified specialty technicians support these programs and overall plant maintenance. The individual maintenance programs focus on equipment uptime, optimizing equipment PM and predictive maintenance requirements, implementing and expanding operator care procedures, and using reliability tools to analyze equipment deficiencies.

By focusing on reliability-based maintenance concepts and workflow processes, equipment downtime is now less than 2%. Because of optimization efforts that started in 2008, PM activities have been reduced by 43% with savings of $3.9 million. Even with reduced PM activities, the plant has seen an increase in equipment uptime and availability. Given this focus, the maintenance department has been able to support greater than 90% equipment utilization within the APl plant and a 25% increase in volume in the DP plant.

Part of the reason the maintenance organization at the Kalamazoo plant has been so efficient can be attributed to cross-training. “A few years ago, we not only added a multiskill technician classification, but also focused on technician cross-training,” said Mark Callahan, senior manager, reliability engineering. “As an example, machine repairmen are trained to lock-out/tag-out the electrical side to disconnect motors in order to do a pump repair or replacement without having to pull in an electrician.

It’s actually working out very well,” Callahan said. “This has made us much more efficient in getting work orders completed in a timely manner and getting production back up and running.”

Automation diversity

The automated cartoner shows is integrated with other pieces of equipment associated with the Pfizer plant. Courtesy: Pfizer Global SupplyDiverse plant operations require diverse automation solutions. Multiple DCSs control the batch processes in the API plant. “We’re trying to reduce our DCS footprint,” said Thomas Andrews, senior manager, process automation. “Our batching system was installed prior to the ISA S88 standards. As we phase in the new DCS platform, we will focus more on an S88 implementation. We’re moving to a more flexible, agile batch solution, smaller phases, and more control at the lower levels.”

The S88 standards establish a consistent set of batch control standards and terminology to define the physical model, procedures, and recipes. The standard is intended to upgrade the controls to incorporate a contemporary batch control philosophy.

DP plant operations typically rely on PLCs with HMI and SCADA interfaces. “We use PLCs in the packaging areas and with robotics,” Andrews said. “We also have a lot of check-weighing systems. There’s a large amount of integration between the various pieces of equipment associated with the DP plant.”

Andrews manages a team of 17 automation engineers. “We’re managing some 95,000 to 100,000 I/O,” said Andrews. “The diversity of engineers required for a site like this is from one end of the spectrum to the other. From understanding instrumentation, process control, the processes, DCSs, HMIs, SCADAs, and the interface issues that are encountered, to the drug product technologies, filling, freeze-dry, inspection, the robotics for handling materials and running extremely fast lines, it really takes a lot of talent. And I’m fortunate to have been involved in assembling this team of engineers and putting that diversity together. We have packaging engineers, chemical engineers, and teams that know electrical, mechanical, and computer systems. It brings such a diversity of solutions to the table, it really is great.”

Improving safety

Pfizer’s Kalamazoo plant takes safety seriously. From 2011 to 2012, the plant cut the number of lost-time accidents in half, from six to three. The number of OSHA recordable incidents was reduced by nearly 30% during the same period.

In 2008, Michigan OSHA recognized the facility as a Michigan Voluntary Protection Program (MVPP) STAR Site with a recertification in 2011. The Kalamazoo plant is the state’s largest facility and one of only 32 sites in the state to hold the certification. “We actually invited Michigan OSHA to inspect the plant and review our programs,” said Ronald Walko, senior manager, safety and industrial hygiene. “They sent two people to look at our chemical process safety program—that was the first step. If we didn’t pass those inspections, they wouldn’t have gone any further.”

During the next visit, Michigan OSHA sent seven inspectors for two weeks. “It was incredibly extensive.” Walko said. “They looked at our safety culture and Safety and Health Management System for such elements as management commitment, hazard prevention, colleague engagement, and how we do risk analysis in the plant. They assessed what kind of controls we have in place, and the PPE we use. They also looked at our training programs and verified our training records.

Michigan OSHA conducted one-on-one interviews with 138 employees and contractors to confirm that the plant’s safety programs and safety culture were in place and working. “And it was all done at random,” said Walko. “We didn’t get to pick who was interviewed. They randomly picked people from all shifts.”

The plant is eligible for recertification every three years. “It really is very meaningful to all of our colleagues,” Walko said. “The MVPP STAR certification is something that we’re really proud of because, to put it into Michigan OSHA’s terms, we are among the ‘Best of the Best.’”