Back in October 2019, Geerd Jansen, board member of the Brecon Group, was invited to FUJIFILM in Tilburg to talk about cleanroom technology in general and the PP4CE concept in particular. The conversation then turned to the construction plans that FUJI Europe BV intended to implement in an existing factory hall on this impressive site. At the time, he could not have imagined the scale of this wonderful project for the PP4CE alliance.
Life science, a growing business segment within FUJIFILM
The originally Japanese multinational FUJIFILM Cooperation (FUJIFILM) is best known for its world- wide activities in the graphics industry and in the production of photo paper. Possibly less known are the activities that for 80 years have also been within the scope of FUJI, such as electronic imaging, photofinishing equipment, medical systems, life sciences, graphic arts, flat panel display materials and office products, based on an extensive portfolio of digital, optical, fine chemical and thin film coating technologies.
One of these activities is operated within the Fujifilm Irvine Scientific division. In this Biopharmaceutical segment, FUJI develops and produces cell culture media and has production facilities in the United States and Japan. In Europe, the Tilburg facility has now been added and will start production at the end of 2021.
The new plant will produce cell culture media for the biopharmaceutical industry in Europe. This material is used in both large bioreactors and smaller laboratories. Depending on the nutrients contained, specific cells, bacteria and fungi grow in or on the media. The culture media are used in the production of vaccines, the growth of cytogenetic products (such as bone marrow and blood cells) and as an aid in in vitro reproduction techniques, among other things. FUJI expects to realise an annual production of 320,000 kg of powder and 470,000 L of liquids in the first phase.
In the strongly growing market segments of life sciences, high-tech and food, among others, there is an increasing need for modern laboratories and reliable cleanroom facilities.
PP4CE is a strategic alliance of specialised companies active in the 'Controlled Environment' market and works primarily on the basis of the Design & Build principle. This approach provides major advantages in the turnaround time of the various process steps. PP4CE has built up a reputation for being able to realise large and complex turnkey (GMP) projects within tight schedules, but above all is becoming increasingly well known internationally for its extensive range of services and product systems that comply with current guidelines and legislation within the above-mentioned market segments.
After the preliminary talks in the last quarter of 2019, FUJI commissioned PP4CE partner Kuijpers to transform the basic design into a functional design. A design that had to meet extremely high requirements. Think of the ISO 13485 and 14644 standards, European directives, GMP related requirements of the American FDA and of course specific customer requirements.
A complex assignment, of which it was not yet known at the time that it would have to be carried out under the difficult working conditions that the Covid-19 pandemic would cause.
By the end of May, the functional design was almost ready, but shortly after, in June, Kuijpers was awarded the follow-up assignment to carry out the realisation. Speed was essential and the Covid-19 crisis was already causing delays in many ways.
As the main contractor, PP4CE Partner Kuijpers brought in a multidisciplinary team from its own ranks: from controlled environments specialists, building automation experts and experts in security systems and sprinkler technology to electrical and mechanical engineering professionals and air treatment experts. In a construction team context, the assignment was tackled integrally together with the Brecon Group and with a significant contribution from a number of PP4CE partners such as: ASSA ABLOY (access technology), BOLIDT (synthetic floor finishing), WERO (cleaning specialist) and CMI (monitoring and qualification). Brecon Clean Interior supplied all the cleanroom furniture, biosafety cabinets and workstations in the laboratories and ELIS advised on the clothing regime and will also take care of it.
The 'in time' realisation
The project comprised the construction and fitting out of 1,725 m2 of cleanroom, 30 large and small rooms in total, an R&D laboratory of 360 m2 as well as a 60 m2 sampling lab, all realised within the construction shell that FUJI itself handled in cooperation with Kuijpers.
The short lead-time and delayed deliveries of materials due to the Covid-19 crisis made it necessary to maintain a constant dialogue with the client. The increasingly drastic Covid-19 measures called for solution-oriented actions and creative brainstorming in planning and implementation. Without losing sight of the health and safety of the employees involved, we worked hard and flexibly on all sides. The delivery was therefore successful and the achieved delivery date was very close to the original planning. All stakeholders in this beautiful PP4CE project were highly satisfied with the results achieved! At the moment, the various process qualifications are being implemented and production is expected to start by the end of this year.