Customer experience in conversation with Bellaseno

“Having our own cleanroom speeds up our development process tremendously.”

June 2021

At ProCleanroom, we’re proud of our products and services, but we’re even prouder of our relationships with our customers. This blog series focuses on customer stories from various industries. What challenges do entrepreneurs face in these industries and how do cleanroom solutions play a role in their business? This time we talk to Mohit Chhaya (Chief Executive Officer) of Bellaseno. A conversation about the significant contribution that Bellaseno makes to the medical world with their products and how having their own cleanroom helps them to work faster, more pleasantly and more productively.

Bellaseno is an ISO 13485-certified company from Germany that develops innovative products for the medical sector. They have developed a new type of implant, with which the body’s own tissue takes care of the gradual replacement of the implant. Bellaseno is at the forefront of the development of these implants, which are made of a 3D printed polymer structure, which dissolves itself over a period of 2 years. This ultimately leaves a natural structure of the body’s own tissue. With the help of these implants, after breast surgery or breast cancer, for instance, a breast can be rebuilt with natural tissue.

Challenges
Mohit explains: “We are manufacturers of implantable medical applications. Therein also lies our greatest challenge. The limitation of particles in the air and a maximum amount of microorganisms (bioburden) per product is very important within our production process. Our cleanroom does not have to be completely sterile, but the maximum number of microorganisms in critical areas have to meet strict requirements. For our products, this is a maximum of 10 CFU (colony-forming unit) in each critical area. In the past we rented a space in a High-Tech cGMP (Good Manufacturing Practice) cleanroom suitable for sterile processing of pharmaceutical and gene-therapy products with a cleanliness class of EU cGMP class B (ISO class 5). For our products, the cleanliness requirements of the cleanroom are lower than the cleanliness class of the rented cleanroom. This entailed unnecessarily high costs and production time.

Solution
After weighing up the figures, we decided to purchase our own cleanroom. After an extensive supplier evaluation process lasting almost a year, ProCleanroom came out on top. Our new, modular cleanroom has a requested ISO class 7 (at the moment it even achieves ISO class 5 due to overcapacity of the filtration system), but the amount of microorganisms on our products has remained the same as it was in the rented, expensive high-end cleanroom. An excellent result. The limit for the amount of microorganisms per product is 20 CFU (colony-forming unit) and currently the products contain only 2 CFU on average, which clearly shows how clean the new modular cleanroom is. Moreover, the cleanroom can be expanded in the future, with the current filtration and ventilation system remaining adequate.

One point of contact
Mohit continues: “What was very important to us was to have a partner who could manage the whole process from A to Z and who could provide us with good advice. ProCleanroom said to us: ‘Tell us what you need and we’ll take care of it’. That flexibility was quite a difference from other companies. We were looking for a (minimum) ISO class 7 cleanroom, which was equipped according to our own wishes and met the requirements for the production and testing of 3D-printed structures for medical applications. ProCleanroom began the process by providing comprehensive advice. Besides giving advice and supplying the cleanroom, ProCleanroom also took care of the validation. They also supplied furniture, consumables and accessories. Having one point of contact is very nice and speeds up the process”.

Smooth remote collaboration
Mohit talks about our collaboration: ProCleanroom and Bellaseno are located more than 600 kilometres apart. In addition, there were constraints due to additional measures imposed by the government in connection with COVID-19. Still, the cooperation was very nice. The mutual communication was even smoother than with some local parties. What we appreciated greatly was that Niels (Managing Director ProCleanroom red.) travelled to Leipzig on very short notice to validate our cleanroom as soon as possible and thereby deliver it within the desired planning. This shows that ProCleanroom attaches great value to providing personal service and delivering projects correctly.

It was very important for us that the cleanroom was delivered quickly, because very important medical studies were underway at that time, which had to be tested in a cleanroom environment. Due to the tight deadline and planning, ProCleanroom could have said no, but they didn’t. Together, we ensured that our cleanroom was designed, installed, furnished and validated as quickly as possible.

An investment with a return
As an entrepreneur, if you invest in something, you want the return to exceed that investment. We ask Mohit how he looks back on the investment in his own cleanroom. Did the investment give Bellaseno what they had in mind? Mohit responds: “Absolutely! We had the choice of purchasing our own cleanroom or continuing to rent an external cleanroom. We based our decision on an ROI calculation as well as sterility standards needed for our products. Research showed that renting the external cleanroom was much more expensive for us in the long run. The calculation showed that the purchase of our own cleanroom would be more profitable than the rental option within just six months. It also turned out that we had unnecessarily high costs for the rented cleanroom, because the cleanliness of the cleanroom is higher than required for our products. This entailed unnecessarily high costs. In the rented cleanroom (EU cGMP class B, ISO class 5), the clothing regulations are much stricter and, as a result, there was a lot more unnecessary use of clothing and consumables (think coveralls, gloves, hairnets, mouth caps and overshoes). In the long run, this makes a lot of difference in terms of costs. Costs that we are now saving while still maintaining the same sterility standards.

Return through speed and continuity
Now that we have our own cleanroom, our researchers can perform tests in the cleanroom at any time of the day. Previously, the process was regularly delayed because the rented cleanroom had to be reserved well in advance. The purchase of our own cleanroom has therefore certainly contributed to increasing the speed with which research can be carried out. Another advantage that translates into return is the presence of employees in the same building. The lines of communication are shorter because the physical distance between them is much smaller. A special transparent wall allows employees to communicate with other colleagues without having to enter the cleanroom and change their clothes. We work faster, more pleasantly and more productively”.

Satisfied?
Bellaseno is a satisfied customer. Mohit concludes: “ProCleanroom really proved themselves and they positively differentiated themselves from other parties that had submitted offers. They came out on top. Both in terms of delivery times and price”. When we finally ask Mohit in what area ProCleanroom can still improve itself, he smiles and says: “No, I can’t think of anything, really. A good sign, I think, that it takes me so much effort to think of something ProCleanroom could have done differently. We’re just really happy to have a partner like ProCleanroom”.

A satisfied customer: that is why we do it. ProCleanroom: build your expertise.

Curious about the possibilities, opportunities and cleanroom solutions for your business? Please contact us and let us inform you. Call 040 40 02 874 or e-mail info@procleanroom.com.

Would you like to read more about other cleanroom projects? Check out the case studies on our website: https://procleanroom.com/case-studies/

In the next blog, we will introduce you to Jeroen van Westing General Manager at Vacutech. Vacutech is an expert in the production, welding and assembly of high-quality vacuum products for the semiconductor and process industries and research institutes.