| Category: Success stories

Top expertise in cleanrooms, validation and quality

Feicon Oy is a company established in 2014 that offers expert services for cleanroom, validation and quality development. Hich-tech countries like Finland have an extensive need for expert services in this field. The proficient staff at Feicon enable hospitals and companies in the pharmaceutical, laboratory and food industry as well as medical device manufacturers to make sure that their facilities, equipment and systems fill the requirements set by the authorities and clients alike. Jari Suhonen, the company’s founder and managing director previously worked years as a development engineer at Orion Oyj, where his responsibilities included device and system validations and cleanroom facilities. 

Thanks to his long experience in ordering services, Suhonen could identify certain development needs and wishes that clients have. Realizing that his experience and vision could enable him to provide extensive help to clients, he decided to start up his own company.

“I wanted to try something new in my career and my own company allowed me to make use of the competence that I had built when employed in the pharmaceutical industry. While Orion continues to be one of Feicon’s large clients, we’ve obviously attracted many others, too. The company has engaged in broad cooperation with various companies and organizations. Our clients have included Kuopio University Hospital, FinVector, a company manufacturing viral and gene therapy drugs and the Kuopio Center for Gene and Cell Therapy (KCT), a research and development company focused on gene and cell therapy. We work in both GMP in the pharmaceutical industry and research but the same rules also apply to areas such as system validation in the medical device industry”, Suhonen explains.

The company currently employs six people with a background in engineering, including automation, mechanical and process engineering. Employees must have knowledge of many quality and standard regulations and keep updating their skills related to Good Manufacturing Practice (GMP), among other things. Feicon also has cutting-edge equipment, including cleanroom measurement devices (often based on laser technology), which must be constantly maintained and calibrated to ensure reliable measurement results. Meeting the requirements set for cleanrooms must be verified at each project phase: As Built, At Rest, and In Operation. 

As a result, competence in the company must be carefully verified and the work carried out requires compliance with the law and the requirements set in standards. Those carrying out measurements and validations must have the required qualifications and also follow any client instructions. With companies operating in the EU sector, EU legislation is complied with, but when working with a company importing to the US, the regulations set by regulatory authorities such as the Food and Drug Administration (FDA) must be followed. Currently, Feicon has both kinds of clients. 

Challenged by changing regulation

As the EU’s Medical Device Regulation (MDR) becomes more stringent, medical technology companies and their suppliers face significant challenges in ensuring their devices comply with the new regulations. With patient safety at the forefront of the MDR, it is critical to partner with a validation service provider that understands the regulatory landscape.

Feicon Oy provides top-notch medical device validation services that meet the highest standards of compliance with the MDR. The company’s experienced team of experts specializes in helping manufacturers navigate regulatory requirements, ensuring that their devices are safe, effective, and compliant.

“We understand that validation is a critical part of medical device development, where various tests are conducted to assess the device’s performance, reliability, and safety. We also know that documentation of the testing process and results are essential for regulatory compliance and to showcase the device’s safety and effectiveness to users and stakeholders. At Feicon Oy, we offer tailored solutions that meet the unique needs of your device, streamlining the validation process and reducing time to market. Our services include a validation plan, test protocols, and a validation report – all conducted in accordance with internationally recognized standards such as ISO 13485 and ISO 14971”, says Suhonen.

The picture shows the data loggers in calibration after validation.

Lifecycle model and low-threshold services

“We’re not just offering individual validations; our aim and intent are to provide a so-called lifecycle model. That allows us to help our clients already when the client is in the process of acquiring a system or is beginning to manufacture a product. Together, we will be able to determine the requirements and through this process, take the project to the finish line. For example, when the aim is to validate a system for implementation, the project takes between 3 and 6 months. This also involves the management of deviations and changes, which require carrying out testing during the process. Feicon also produces the required documentation and validation testing. In cleanroom projects, we often get involved already at the preliminary planning stages and our related consultation services are available to purchase. The available resources depend on each client, but we often serve as an extra set of hands when the client does not have enough time for everything”, Suhonen continues

Collaboration matters

”I had been meaning to contact Kuopio Health for a while. The time for this came in early 2023 when I participated in the FIB (Finnish Bioindustries) goes Kuopio event. Kuopio Health was there to present its activities, and I happened to be sitting next to Erkki Soini, the Chair of the Kuopio Health Board. He introduced me to Aki Gröhn, Kuopio Health’s CEO, and after discussing with him I realised that this is what we need as a company. It was clear we both has a mutual intent for collaboration”, Suhonen explains about becoming a Kuopio Health member. 

“One key factor was that the ecosystem could provide us with help and partners that could make it easier for us to broaden our operations outside Finland. The work to expand the company to the international level is ongoing and the strategy process for this purpose was launched earlier this winter. I believe Kuopio Health can benefit us considerably and we will also bring our expertise and network to the ecosystem. Even if we do not have the expertise required by a given client, we have access to an immense partner network that will enable us to refer the client to contact the right person. 

The threshold to contact us is low, so you should not hesitate to contact us if there is anything on your mind. We also offer technical help and support and can assist you with device procurement, for instance. If you do not know what you should determine or who you should contact for quotes, we can support you. Even though I’m not fully familiar with the community yet, I believe that there are members and companies there with a need for cleanrooms, validation of devices and systems or development of a quality system. I have noticed that Kuopio Health has active operations, and I’m sure we will be interested in participating in the ecosystem’s working group activities in the future”, Suhonen concludes. 

Read more about Feicon Oy

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