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