“Personal protective equipment has always been my passion,” says Franck Bureth, EMEA Regional Category Leader of Kimberly-Clark Professional. He joined the company in 2008 as the Scientific Territory Sales Manager for France, which led to his present role.
With a Master in Chemistry and a keen sense for business, Bureth has defined the strategy for the hygiene and safety specialist, driving several workstreams, from product development and marketing to technical sales support.
“I work in close collaboration with my global counterparts to share best practice and standardise the execution of global solutions, such as the Kimtech A5 sterile cleanroom apparel,” he tells me, and I hope he is ready to talk about hot topics in the industry, from regulatory and sustainability all the way to tips on donning.
“Common challenges of our clients range from complex and difficult aseptic donning procedures, operator comfort, the proliferation of colony-forming unit (CFU), and apparel performance in terms of filtration efficiency,” Bureth reveals, noting clients will engage with partners that offer solutions aligned with their biocontamination control strategies so that quality and validation departments make the right garment selection. “Clients must ensure their products are manufactured safely, efficiently and predictably [and] our solutions must fit seamlessly with these requirements,” he says.
Clients will engage with partners that offer solutions aligned with their biocontamination control strategies so that quality and validation departments make the right garment selection
Bureth is in no doubt the pharmaceutical industry has evolved from the last decade considerably, and continues to develop at a rapid pace, meaning cleanroom apparel providers had to follow suit. He names the rise of automation, isolation technologies and the trend towards patient-specific small scale batch manufacturing with single-use sterile systems as some of the continuous improvement methods addressing key production processes, such as sterility assurance and aseptic manufacturing, where cleanroom apparel play a vital role.
It was in the wake of these advances that Kimberly-Clark Professional launched the Dressed for Success campaign in 2017, aiming to change the conversation on sterile cleanroom apparel and engage with the customer differently. “We identified a need globally that required us to disrupt the status quo and the assumption that laundered re-usable sterile apparel will continue to perform adequately through repeated use,” he says.
The outcome of the campaign was a visually stunning and impactful message implemented across Europe, North America and the Asia Pacific region. The strategy was to demonstrate the benefits of the Kimtech A5 Sterile Apparel range to clients globally.
With more than 20 years on the market, the early focus of the Kimtech brand was on laboratory research; in 2009 the company added the Kimtech A5, a laser-focused range for sterile cleanrooms. “The company has continued to innovate in this space, helping customers to minimise the incidence of human contamination while also introducing a range of accessories such as the Kimtech Sterile Integrated Hood and Mask, designed to enhance sterile donning efficiency,” he explains.
Bureth tells me that in-house research found donning behaviour and operator comfort are the main factors for human error leading to contamination risks, and these findings inspired the Kimtech A5 product development.
“[The range was designed] to maximise donning effectiveness through visual touch-point indicators, unique folding mechanisms to avoid contamination and other features, all designed for simplicity and effective aseptic donning,” he explains. “Comfort can affect operator concentration and ultimately effectiveness,” he says and claims the Kimtech apparel solutions are designed to maintain ideal body conditions, keeping the operator cooler for longer while inhibiting perspiration.
Bureth believes it is no coincidence that the Kimtech A5 range meets the requirements set out in the draft Annex 1. “It just goes to show that the industry is moving towards enhanced contamination control policies, which improve the environment in which pharmaceutical products are manufactured,” he says.
The qualification of suppliers has taken centre stage in current regulatory updates, and Bureth knows this signals a new era in the client-provider relationship. “Every customer has their own approach regarding qualification, and these can vary tremendously in terms of complexity, depending on the process and type of cleanroom environment. We work tirelessly to tailor our approach to each customer to ensure their expectations are met, every step of the way,” he says.
Speaking about what suppliers can do to help customers in the qualification process, Bureth suggests: “Listen to the customer and determine their requirements from the outset. Agree on the desired outcome and execute with excellence, communicating clearly through each milestone, maintaining an open dialogue throughout.”
The sustainability debate
Bureth doesn’t dodge the questions about his views on the single-use versus re-usable garment debate; he knows the discussion will continue well into the future.
“Each solution has its own merits depending on the environment,” he says. “However, it is important to note the general trend towards sterile single-use apparel across the pharmaceutical industry, and it’s no coincidence that Annex 1 reinforces this position. The bottom line is that a single-use solution providing constant bacterial and particle filtration efficiency at each entry, eliminating the risk of cross-contamination, will provide a higher degree of biocontamination control,” he argues.
It is important to note the general trend towards sterile single-use apparel across the pharmaceutical industry, and it’s no coincidence that Annex 1 reinforces this position
It is here where sustainability comes to play a relevant role in choosing cleanroom apparel. “As climate change becomes an ever-increasing phenomenon across the world it is important for everyone, including companies, to explore ways to minimise their impact on the environment,” Bureth says. “Many of our customers have their own sustainability goals, and we contribute to their objectives as the only PPE supplier offering a recycling solution for Kimtech Gloves and Apparel," he claims, pointing to the company’s RightCycle scheme.
“Kimberly-Clark Professional has long held the philosophy that it is important to not only provide the right solution for the right task but also to think about the end life of the product, and consider recycling opportunities wherever possible,” Bureth tells me, commenting on the birth of the eco-friendly initiative, RightCycle.
“This is a unique programme where used gloves and apparel are collected and upcycled into eco-friendly products that can be enjoyed for many years,” he adds, noting this programme was created and launched several years ago, well ahead of the Dress For Success campaign. “It serves as a natural fit as an overall solution bundle,” he says.
Today, over fifty companies participate in the EMEA RightCycle programme. Since 2014, they have helped to divert over forty tonnes of glove and apparel waste from landfill. “We endeavour to support sustainability through the value chain and remain committed to reducing waste to landfill,” Bureth promises.
The conversation with Bureth is uplifting as I learned Kimberly-Clark Professional is a company keen on changing the conversation on sterile cleanroom apparel and engage with the customer differently.
N.B. This article is featured in the November 2019 issue of Cleanroom Technology. Subscribe today and get your print copy!
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