Extension of the LFB Group’s production site in Alès
The project concerns the extension of the LFB production unit located in Alès. It integrates the creation of an active pharmaceutical substance (API) production unit based on animal cell culture (USP) and purification (DSP) of products from transgenesis or other biomolecules. The project is carried out on the site in operation. Cap Ingelec carried out a complete project management mission.
A HIGH LEVEL OF REQUIREMENT
Loïc Pawliez is Project Manager. He gives us his feelings on the LFB Manufacturing site, which he followed from start to finish, as close to the ground as possible.
“I was seconded by Cap Ingelec to the site for the entire duration of the works to meet the specific requirements of the project but also to guarantee the continuity of production of the existing equipment. The steering committee, which brought together the main protagonists of the project every month, allowed us to control the progress of the project and to implement the necessary action plans to ensure that the fixed objectives were respected. There are three main challenges in this project, involving all trades (VRD, GOE, SO, HVAC, fluids, electricity and FMS/BMS): the day-to-day monitoring of the static, dynamic and performance quality of the site with the involvement of an independent body, the implementation of numerous utilities specific to the project and the creation of a new electrical delivery station which is strategically important for the site. And finally, a project integrating very high standards of cleanliness, safety and quality related to the pharmaceutical sector.”
TECHNICAL DATA SHEET OF THE SITE
Creation of two USP/DSP production areas and associated rooms
Creation of air treatment installations for class C and D zones
Establishment of a new electrical transformer station (1200 kVA and associated LV backup)
Creation of a biological effluent treatment station
Implementation of an automatic sprinkler system, in compliance with FM Global
Creation of a tertiary level in the upper part of the building
Interview with Roland Beliard, President of LFB Biomanufacturing
What constraints had to be taken into account for the successful completion of this project?
The major constraint was to build a new 700 m² building (3,000 m² of floor space) between two existing workshops and to join them together. The second was to ensure this extension without interrupting the activity. For this, it was necessary to ensure intercommunications between the old spaces and the new one. This situation resulted in the creation of temporary accesses for the personnel. This project was subject to strong planning issues. Although our production is carried out during the week during normal office hours, our process requires maintenance 7/7 and 24/24 hours since we are developing drugs from living organisms. It was therefore out of the question to cut our utilities at any time. The programming of technical stoppages in perfect synergy with our organization was essential. Cap Ingelec was also able to take into account an imperative deadline since the extension had to be delivered imperatively before the end of 2016. Finally, it was important to respect the budget, of the order of 10 M€.
How do you judge the collaboration with Cap Ingelec?
Given our imperatives, we appreciated that this collaboration started quickly and efficiently. The engineering company immersed itself very quickly in the dossier and showed great reactivity. This capacity to adapt and react was accompanied by a very good understanding of the multiple parameters of a complex site where it was essential to maintain the activity at the same level of quality and safety. This efficiency was verified on all the missions entrusted to Cap Ingelec. I am thinking of the construction of the extension itself, but also of the setting up of the GMP (quality), passing through the management of effluents or the springklage of the premises for example (automatic extinction system).
What ingredients did Cap Ingelec use to carry out its missions efficiently?
First of all, the company knew how to find and bring the right skills useful to the project. Then, they put in place an organization which allowed for a very good management of the site. I include both the project manager on site who was able to lead and coordinate the various parties involved and the steering committee which made it possible to control the various aspects of the project (reporting, monitoring, etc.). Cap Ingelec’s knowledge and experience in the world of health and industrial clean rooms also played a role. Together, we sought to respect in the smallest details the European and American regulations specific to the manufacture of medicines. It is moreover planned that we will receive the FDA (Food and Drug Administration2) in the first half of 2017 in anticipation of marketing our products on the American market.