Improved facility design raises operability and GMP solutions

To provide the best solution for Laboratoire Aguettant SAS’s greenfield laboratory and packaging facility in France, NNE challenged another company’s conceptual design and offered an alternative method to better support the customer and vendors with a sharp pharma focus and GMP understanding.

After NNE's feasibility study in 2010, the French pharmaceutical company Aguettant selected another company to provide the conceptual design of its new production facility in Lyon Gerland. In 2011, Aguettant sought experts who could challenge the solution.

We proposed a change of the project definition after reflecting on our early assumptions during the feasibility study and our new approach,” NNE project manager Franck Martel explains. “The customer was convinced by our value-adding pharma knowledge and our ability to increase capacity, modernise technology and raise their pharma level – all while meeting the strict regulatory requirements.

In turn, Aguettant asked NNE to tender for the engineering, procurement, construction management and qualification (EPCMQ) of its new production plant with a new line for ampoules with isolator technology to increase capacity. In addition, NNE supported the transfer of current lines for vials, prefilled syringes and ampoules from the previous production area into the new area.

Pharma engineering know-how to meet critical customer needs

Though NNE led the EPCMQ, Aguettant worked with a French construction company for a turnkey contract for the building and architecture. NNE cemented a strong link between Aguettant and the construction company to meet stringent good manufacturing practice (GMP) requirements. While the construction company managed the building part of the project, NNE focused on how to establish cost-effective manufacturing.

Two years after the project closed, NNE and Aguettant met for a feedback session to study lessons learned on operability and maintainability of the facility and learn more about the customer’s experience of operational expenditure (OPEX). It was the trust-based relationship NNE established with the customer that stood out:

There was strong collaboration within the NNE teams,” says Christophe Deycard, Industrial Director of Aguettant. “We felt commitment from NNE from all hierarchical levels.”

In July 2016, Aguettant contacted NNE to review the customer’s own engineering service to ensure GMP compliance in all processes and piping and instrumentation diagrammes for new projects planned for its other production site in Champagne. In turn, the customer made some changes in the user requirement specifications based on NNE's extensive review.

Nearly seven years after first contact, Aguettant and NNE continue fortifying their strong relationship and joint effort to design and build high tech laboratories and facilities.

The customer was convinced by our value-adding pharma knowledge and our ability to increase capacity, modernise technology and raise their pharma level – all while meeting the strict regulatory requirements.

Franck Martel, project manager, NNE

Quick facts

Customer

Laboratoire Aguettant SAS

Country

France


Project duration

2011-2014

Services provided

Preliminary and basic design, tendering for contractors, design review, studies of contractors, construction management, commissioning and qualification