A Big Challenge for Supervisor Wally Thompson is Navigating Non-U.S. Regulatory Agencies
Wally Thompson is the Microbiology Supervisor at Gambro in Daytona Beach, Florida. Gambro is a global medical technology company, with manufacturing facilities in countries all over the world including Italy, Sweden, Germany, France, Korea, and China, that develops and manufactures products and therapies related to kidney diseases.
“We provide our solutions to hospitals and trauma centers for use in intensive care situations,” Thompson says. Thompson’s lab is one of Gambro’s many facilities around the world. His lab provides microbial analysis for the products—medical device and pharmaceutical solutions for renal intensive care—manufactured at that facility.
“We are also responsible for the analysis of the water used for product manufacture, environmental monitoring of clean rooms, and other projects associated with the facility,” he says.
Gambro Daytona manufactures solutions that are used in renal intensive care. Part of the product monitoring includes pre-sterilization testing to monitor potential organisms and their amount before a product undergoes sterilization.
“We test the product after sterilization to make sure it’s sterile,” Thompson explains. “We also test for liquid particulates where the particles could be living organisms or other foreign matter that you can’t see with the eye but are large enough that they could cause a problem for our patients. There are standards that we follow such as [The United States Pharmacopeia] USP, [The U.S. Food and Drug Administration] FDA guidelines, and that sort of thing.”
One such problem could be the presence of endotoxins—a type of toxin that’s found in the cell walls of some bacteria—in the final product. When certain bacteria die, they release spores, which are basically resistant to the steam sterilization and are near impossible to get rid of. If such impurities end up in pharmaceutical products over a certain amount, they could cause fever in patients. But with proper control measures, endotoxin doesn’t make it to the final product.
Thompson’s team also monitors the environmental condition of the clean rooms—rooms with little particulate matter such as dust and bacteria, used for manufacturing sterile products— through air-viable, surface-viable, and air-particulate testing.
“We manufacture our products in clean rooms—they are ISO Class 8, which is a fairly clean environment, and we check the rooms and the operators for contamination to make sure that they limit the amount of contamination that could possibly contaminate our product,” Thompson says. “Even though our product is not exposed in most of the rooms, we try to maintain that contamination-free environment just in case.”
The production area in Daytona Beach, Florida, which includes the quality control labs, is almost 100,000 square feet. The microbiology lab takes up approximately 1,500 square feet of this space.
“Our manufacturing plant operates seven days a week,” Thompson says. “We have personnel working in the lab seven days a week. Technically we don’t need to be working on the weekends, but it actually works with a couple of my employees’ schedules better if they can work on the weekend and have a day off during the week.
Thompson and his five-person team run the laboratory. Thompson reports to a quality manager who reports to the Vice President of Quality for the America’s group and then on up the chain to the President of Quality for the company.
There are other microbiology labs within the company as well, Thompson explains. “There’s a lab in Alabama, a lab in Germany, one in Italy, and a few more.”
To run the operation, Thompson has put together a team of biologists and chemists.
“My employees have diverse backgrounds; [we have] a chemist, two biologists, and two working on degrees,” he says. “I am a biologist by degree and have worked in the chemistry lab as well as the micro lab.”
Together, the team processes thousands of samples a year. For example, last year Thompson and his five employees went through more than 17,000 just for the environmental monitoring that they conduct on a weekly and monthly basis.
“My lab coordinator, Adria, does a terrific job keeping the day-today activities in the lab organized and running smoothly,” he says. “[Also], communication is the key to making sure all testing is performed correctly. It is especially important when working with the other labs and production on special projects.”
Inventory, maintenance, and hiring
To ensure that the microbiology lab is well stocked, everyone takes part in routine inventory. When a team member notes that a material is running low, he or she reports it to the lab coordinator—one of the five lab staff designated to handle such matters.
“My coordinator handles the ordering and makes sure that inventory of materials stays at a level where we always have enough to perform our testing,” Thompson says.
Maintenance of lab equipment is also handled by lab personnel. The lab staff utilize a variety of instruments. However, the top five most used instruments are the Rion KL-04 Liquid Particle counter, Cambrex WINKQCL endotoxin software with ELIX reader for endotoxin testing, Biomerieux Air Ideal impact air sampler, Metone Hand Held Particle Counter-6, and Binder BD400 Incubator
“If there are other issues outside of equipment or if there is a problem that cannot be handled, our maintenance staff will investigate and repair or make sure the proper vendor is contacted to repair,” Thompson says.
Thanks to smooth protocols and organized scheduling, the small and competent staff team handles all these tasks without a hiccup.
Having people you can trust who are dedicated to what they are doing and possess good skill sets and knowledge to back it up is very important to running a successful lab, Thompson says.
At times, when a team member has to leave his or her position or a new position opens, Thompson takes great care to ensure that a person with a good fit joins the group.
“I’ll bring the need for new personnel up to my boss and she’ll request an additional person to work in the lab,” Thompson explains. “Once the approval comes from corporate then we start bringing in potential employees.” Depending on the position being filled, interviews are conducted by department, HR, and associated managers.
“A lot of times we’ll go through a scientific temp agency, bring the person in and I and maybe my manager will interview them,” he says. “Then from a number of interviews that we have, we will determine who seems the most qualified and hire that person through the temp agency. If that works out then we usually make that person permanent.”
To keep employee morale high and the staff productive, both the company and Thompson work hard to reward those who are doing excellent work.
The company has an employee of the month for the facility, who receives the Top Dog award. Additionally we have employee lunches, holiday and health fairs where the company provides free health screenings and exams, and we serve a healthy lunch to our employees,” Thompson explains.
“As far as what I do, every once in a while I’ll bring in breakfast for my employees to say thanks for doing a great job.”
The biggest challenge for a microbiology lab that supports pharmaceutical manufacturing is probably being in compliance with all the applicable regulations. The lab supervisor typically handles the largest burden of the task.
“It is difficult to keep up with standards and guidelines since they are constantly being updated,” Thompson says. “It is also a challenge to ensure that we are following the regulations from the different countries that we are selling our products or will be selling our products to.”
Being a global company, Gambro is expanding into markets outside the United States, such as Mexico. Most recently, the company is working on approval to sell its products in Brazil, which has regulatory agencies that function much like the FDA.
“They have their requirements just like the FDA does, a lot of similar things, but some things are different and so they inspected our facility to make sure that we meet their regulatory requirements for manufacturing our product and selling it in their country,” Thompson explains.
Although challenging, such expansions are new and stimulating for Thompson.
“It’s exciting working on getting the requirements that meet the expectations of other regulatory agencies, whether it’s Brazil, Europe, Canada or Mexico,” he says. That’s exciting as well as challenging because they all vary a little bit. Another country might have a slightly new requirement that we’re not used to seeing and it’s my responsibility to stay on top of that to make sure that we can meet those requirements.”
Additionally, the company is continually developing new formulations of its product in order to provide solutions that will encompass a wide range of needs from the patients, Thompson explains.
“Each time we work on these projects, it is an exciting time because of the new ideas, methodologies, and all other aspects that go into the project.”
Thompson spends most of his day overseeing details related to these projects, revising documents, preparing project protocols and final reports, and keeping an eye on the events in the lab. But to him, it’s all in a day’s work.
His advice to other lab managers
“Look at the big picture and don’t get drawn into spending all of your time and focus on one or two details,” Thompson says. “This may cause you to miss an important element or requirement and leave you scrambling to come up with a solution. Listen to your employees and allow them to have input on the tasks performed in the lab. They know what works best and you need to make sure that everyone is on the same page.”
Thompson attributes his success in the lab to his supportive family, a competent staff, and the overall importance of the work.
“I know the importance of what I do in the grand scheme of saving and improving the lives of the patients who receive our product,” he says.
Sara Goudarzi is a freelance writer based in New York City. Her website is www.saragoudarzi.com.