Vanessa Morini is the leading figure of a new company in Belgium that specialises in cleaning and disinfection of cleanrooms. TRU is headquartered in Genk, just over an hour drive east of Brussels, and employs 10 people working across seven satellite offices in the country. “These [branches] ensure that we are never far away from our employees and customers,” Morini tells me. To tap into the Dutch market, TRU also operates from an office in the Netherlands.
It has been “flying start” for TRU, Morini says after three months of operation. Indeed, two weeks after the October launch, an international company in the automotive sector that had recently started a factory in Belgium, with a cleanroom spanning 1,500 sqm, contracted TRU for a job. After that first customer, others followed from pharma, universities and hospitals.
Entrepreneurial spirit
Italian-Portuguese by origin, Morini identifies as a visionary and someone who’s not afraid of uncertainties. “Life would only be half as much fun if I didn’t take risks,” she quips.
Her professional career span 17 years working at big names in the pharmaceutical industry. Seven years at Jansen, her first employer after graduating from a bachelor degree in chemical process technology, and an equally long tenure at Genzyme, now Sanofi.
I wanted to fill in the gap in the market. Many cleaning companies say that they have the knowledge, but the reality is often different
Her progression at Jansen solidified her rapport-building skills. Morini worked as a Safety Health Environment (SHE) Engineer at the Geel site and helped obtain a new environmental permit for the facility. The next step up saw Morini join the Process Operations department as a Cleaning and Validation Engineer responsible for the smooth running of both activities. In this role, she implemented several improvements to the cleaning process, including savings in lead-time, quantities of solvents/cleaning detergents, and workforce hours, to name but a few.
“I was referred to as Subject Matter Expert (SME) for the critical environmental cleaning, which made me a spoke person for this topic in both the internal and external audits. I owe my lean mindset to my seven years at Janssen,” she says.
Morini knows she has a solid group of businesspeople and is not shy about it
When Morini moved to Genzyme, in August 2009, she started working as a cGMP engineer at the Maintenance department. “Quite an assignment, because at that time the transition from development to cGMP production was in full progress,” she says. This role took her all over the world, visiting different sites, and she took care of the implementation of best practices within her field of chemical process technology.
It was from these experiences that Morini got the bug for all things cleanrooms. “My interest in cleanrooms has grown mainly from my experiences at Sanofi and the increasing importance of cleanrooms in the industry,” she says. Morini points to the sheer scale of technology innovations in various segments, from the production of nano and microelectronics to nanomedicines.
Cleaning cleanrooms
It was not until four years ago that Morini put all her attention to cleaning cleanrooms. Care, the Antwerp-based cleaning company, approached her in 2016 to set up a new business unit with a focus on labs and cleanrooms. Morini took up the opportunity and was responsible for both sales and operations.
I see us growing to other countries such as Switzerland and Ireland, where the pharmaceutical industry is strongly represented
Over a decade of success, so why quit? It was time to take action on her entrepreneurial spirit. “I was looking for more!” she says. “I wanted to fill in the gap in the market. Many cleaning companies say that they have the knowledge, that they deliver quality, that they go for a strong partnership. But unfortunately, the reality is often different. TRU uses only qualified cleaning specialists; they understand the cleaning and disinfection process and perform everything correctly. We have in-house expertise and knowledge, which enables us to deliver the required quality. I wanted to meet unmet needs. I could only do that by launching TRU.”
But Morini is not alone in this venture. She has joined forces with key names in the cleaning and cleanroom sectors: Jo Nelissen, the CEO of the modular builder ABN Cleanroom Technology; Seppe Thys, Manager of Hamster Cleaning; and Luc Vandeweyer of the Vandeweyer Group, are co-founders. Knowing that TRU’s motto is “100% cleanroom cleaning”, I couldn’t help but wonder what’s the strategy to leverage their position in the market. Has TRU really got what it takes?
Cut the mustard
Morini knows she has a solid group of businesspeople and is not shy about it. For her, their combined expertise is what makes TRU stand out in the marketplace.
“I knew Seppe Thys for some years, and ABN was one of the clients at Care. After the construction of cleanrooms, Care was regularly asked to carry out the first cleaning. Hence the contact with Jo Nelissen,” she explains.
Morini also tells me that in a conversation that she had with Jo, Seppe and Luc were coincidentally sat at the same table. “We quickly realised that together we could make a difference in the market with a new company that exclusively cleans and disinfects cleanrooms. We strongly believe in the focus strategy. This allows us to deliver more than other cleaning companies. We have specialised employees, employees who can give advice to the customer. They know the concept, perform everything according to the rules and understand what GMP is. They cut the mustard,” she says.
The company is developing a digital documentation system fully validated according to GAMP 5 and the FDA’s 21 CFR Part 11
TRU might only have three months on the market, but Morini has big ambitions for the company. “Looking further into the future, I see us growing to other countries such as Switzerland and Ireland, where the pharmaceutical industry is strongly represented,” she tells me.
The company, Morini says, not only carries out cleaning and disinfection in cleanrooms but also takes care of all GMP-related paperwork associated with the process. “We draw up cleaning and disinfection SOPs tailored to the customer [as well as] cleaning documents for the registration of the cleaning and disinfection tasks,” she says. Morini reveals the company is also developing a digital documentation system that’s fully validated according to GAMP 5 and the FDA’s 21 CFR Part 11.
Market overview
One of the first things that struck me from Morini’s business acumen is the way she markets the company; she uses Geoffrey Moore’s model for strategy and the main argument to entice companies to outsource the cleaning process.
“The model Geoffrey Moore uses in his book “Dealing with Darwin” is [one] that you can use within your business strategy to decide which activities to continue and which not to remain competitive. By applying the strategy described in this book, you can make smart changes as a company in your ‘mature’ years and continue to flourish and be remarkable. Other companies who opt for a more conservative strategy tend to lapse into inertia and extinction,” she argues.
Companies who opt for a more conservative strategy tend to lapse into inertia and extinction
For Morini, there are still many pharmaceutical companies in Belgium that carry out cleaning and disinfection of cleanrooms in-house: by production operators as part of their job, or by an internal team of industrial cleaners. “If you apply Moore’s model to the cleaning activity, you can conclude that this activity is ‘context’. Outsourcing this activity will allow the pharmaceutical company to remain competitive. They can fully focus on their core business,” she observes.
Lack of knowledge is, according to Morini, a big issue in the cleanroom cleaning market. “There are a lot of cleaning companies that also clean cleanrooms, but I don’t see them as competitors. There are some larger players who have multiple customers, but the knowledge is totally lacking. They completely rely on the knowledge of the customer, who is usually responsible for training the employees of the cleaning company. No continuity is provided. These companies often take the cleanroom along as an additional service on top of the office cleaning,” she explains.
You don’t ask your vet to look at your eyes, even if they are a doctor
For Morini, such partnerships represent a risk to clients, not to mention a higher total cost of ownership in the long term. “[There are] a lot of hidden costs often followed in training, full invoicing even if not all tasks are performed, and re-cleaning due to bad sampling,” she points out.
Morini speaks with such energy that I’m in no doubt TRU is set up for big things in the months to come. And she is over the moon by realising this business. “[I’m] making my dream come true! Building a business, step-by-step, making a difference in the market!’ she concludes.
To the point
How do you keep up with the latest in technology and products?
I regularly connect with other experts to stay up to date, both in terms of techniques, products, but also for digital applications. For products, I connect with technical experts from Steris or Ecolab, for example.
When it comes to cleaning products for your business, what do you look for?
That depends very much on the customer. Most customers have already selected and validated the products. So they don’t want to change. Only if there is a need to change, I will advise the customer on a suitable product. The choice depends on several factors such as the microorganisms present and the degree of contamination.
What are the most common mistakes you have seen regarding cleaning validation?
Most companies carry out their plan well, but I’ve seen that companies often start their validation without having an adequate cleaning and disinfection plan in place, that they have chosen the wrong cleaning and/or disinfection agent, not aligned to the contamination present in the cleanroom.
Why do these errors occur?
Too little attention is paid to the fact that the cleaning plan needs to be thoroughly designed. Design of the cleaning plan is often done at the end of the process.
For example, I once had a case of a company in the transition from development to GMP production. During the development phase, the contamination in the cleanroom was significant due to various factors, the tests carried out in the cleanroom, and the number of people in it. So a “powerful” detergent was used, and this detergent was validated afterwards. A film was starting to appear on the floor. The detergent had too little contamination to deal with for its normal performance, and a residue was left behind. After this discovery, the detergent was changed and the validation had to be carried out again.
What’s your advice to companies carrying cleaning validation?
Talk to experts, ask their advice, and get guidance in this matter if you don’t have the knowledge. You don’t ask your vet to look at your eyes, even if they are a doctor.
What’s your view of the draft Annex 1?
I am very curious about the final version. I am especially looking forward to the requirement of having a contamination control strategy and on the topic of rotation and the number of disinfectants to be used. Few companies have a substantiated strategy on this.
I am convinced that many pharmaceutical companies will still have to catch up to comply with the new Annex 1. But companies such as TRU, with expertise in the standard, can support them in this.
What is your business goal for 2020?
The sky is the limit! I am very driven and result-oriented, but on the other hand, I also have to be realistic. We’re a start-up. It is important to build up sustainable growth. This also means that sometimes we say “no” to a certain assignment if we can’t do it according to our DNA. But concretely, we expect an annual turnover of about €800,000 by the end of 2020.
N.B. This article is featured in the February 2020 issue of Cleanroom Technology. Subscribe today and get your print copy!
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