At its Bavarian site in Pfaffenhofen an der Ilm, the pharmaceutical company Daiichi Sankyo is systematically expanding its production capacities for the sterile manufacturing and filling of medicinal products. A further construction phase focuses on the highly sensitive filling and sealing process (Fill & Finish).
GMP-compliant cleanroom solutions for sterile pharmaceutical production
Lindner Cleanroom Technology was commissioned to implement a holistic cleanroom concept for the fit-out of the cleanroom areas. The objective was to combine the regulatory requirements of GMP guidelines with efficient, low-maintenance system solutions.
Single- and double-skin Multiclean CPH cleanroom wall systems were installed, characterised by smooth, cleanroom-suitable surfaces and high resistance to cleaning and disinfecting agents. Their modular design supports precise integration into complex production layouts and enables long-term, and therefore sustainable, adaptation to changing process requirements.
Functional door and ceiling systems for controlled processes
The cleanroom walls were complemented by the Swing F MPH tubular frame door system, which has been specifically designed for hygiene-sensitive production environments and can be reliably integrated into multi-stage personnel and material airlocks – a key factor in ensuring process reliability in Fill & Finish operations.
The walkable Line 80S Type 2 ceiling system was installed as the cleanroom ceiling. Large suspension distances, concealed service routing and a highly load-bearing walking surface provide easy access to technical installations and support efficient maintenance of building services and process technology during ongoing operations. Lighting within the cleanroom is provided by LP cleanroom luminaires, some of which feature integrated white and yellow light that can be switched at the touch of a button, as well as RP LED recessed downlights and DL LED cleanroom luminaires, ensuring uniform illumination throughout.
Highest cleanliness classes and reliable airflow management
To meet the highest cleanliness requirements, Lindner integrated high-performance fan filter units with HEPA filters, ensuring a constant supply of ultra-clean air.
The cleanroom fit-out was completed with additional functional components, including ventilation housings within the ceiling construction, SafeChange exhaust air housings for the safe handling of sensitive substances, and high-speed doors to optimise internal logistics.
In addition, material pass-through cabinets were installed to ensure secure transfers between cleanroom areas. Stainless steel wall protection systems safeguard surfaces during daily operations. Ceiling-integrated HEPA filter housings complete the cleanroom concept and ensure reliable air filtration.
Cleanroom walls with surface-mounted impact protection and integrated glazing ensure maximum hygiene and transparency in daily operations.
State-of-the-art cleanrooms provide safe conditions for Daiichi Sankyo’s fill and finish processes in Pfaffenhofen.
GMP-optimised high-speed doors ensure controlled access.
