Feature Article

To reduce the time to market for its latest product line, medical device manufacturer Ferrosan partnered with Clean Modules to have a 325-m² cleanroom facility built offsite in the United Kingdom and later have it installed and validated at its Denmark-based facility. From start to finish, the cleanroom was installed within within 14 weeks.

Choosing the location and construction method for a new cleanroom facility can make a big difference to the programme, budget and end result of a project. Ferrosan conducted extensive research developing a strategy for building a cleanroom that would best suit its budget, time restraints and user requirements.

Time pressure

The tight time restraints would not allow for the construction of a new building in the conventional way. Renting existing facilities at an alternative site would burden the firm with significant new expenses. Based on those factors, Ferrosan opted to construct their new cleanroom facility using an alternative strategy. 

After further research, Ferrosan paired up with Clean Modules, a UK-based cleanroom company that specialises in the design and construction of cleanrooms. Clean Modules is experienced in using pre-built and modular construction. Installing a modular cleanroom is a quick and cost-efficient construction method for projects without an existing shell building. This construction method is based on factory manufacture of the cleanrooms in modular sections, which are then shipped to site, installed and commissioned.

Clean Modules’s modular cleanrooms are constructed with their System I cleanroom panels, composite panels and concrete board within a robust hot-rolled steel frame. Onsite pad foundations need to be installed and services brought to the cleanroom perimeter. The facility does not contain timber and, unlike cleanrooms constructed within converted timber cabins, the company's modular cleanrooms behave like a rigid traditional building and offer a similar durability.

Optimising Construction
To remain competitive, Ferrosan sought to have the cleanroom installed as quickly as possible. A key benefit of Clean Modules’s modular cleanroom construction method is that the facility is constructed as a whole away from site. In the UK, Clean Modules constructed the 235 m² modular cleanroom facility in the United Kingdom, while in Denmark another Clean Modules site team prepared the foundations and converted an existing 90 m² in situ laboratory into an EU GMP Grade D preparation area. The two areas would later be linked together during installation of the modules.

Along with the modular cleanroom facility, a plant skid module housing the Air Handling Unit (AHU) and associated plant was prepared in the United Kingdom. The equipment was installed and pre-commissioned away from site. The AHU only had to be connected to the modular cleanroom facility on site. 

Traditional cleanrooms require the shell building to be completed first. By contrast, the modular cleanroom facility and the air handling plant were prepared off-site. The foundation and in-situ cleanroom area were completed in parallel, enabling construction time to be optimised.

Time on site costs money, especially when the construction site is in another country and crews have to be sent abroad. The benefit of the modular cleanroom solution is that the facility as a whole is constructed away from site in a factory environment. Consequently, the ability to construct the facility at Clean Modules’s premises, with the design and construction facilities nearby, resulted into efficient use of time and low labour and specialist trade costs.

Flexibility 
Designed with the future in mind, the new cleanroom facility is flexible and versatile. To ensure manufacture of the new product can develop with Ferrosan’s demands, the facility will easily allow for future extensions with additional modules.

The hot-rolled frames ensure easy transport, provide the backbone to the facility and make modular cleanrooms feel like traditional rigid buildings. The steel frames also allow for a flexible lay-out, enabling long ceiling spans and the creation of rooms that are larger than the individual modules. The modular cleanroom facility houses a 160 m² EU GMP Grade C production hall that spreads through all five modules. The production hall has a dedicated filling area with uni-directional air flow for filling the product into its primary packaging. Additionally, the production hall houses a secondary packaging area with two interconnected packaging systems totaling 17 metres in length.

An EU GMP Grade C product weighing and mixing room with dedicated extract system and an EU GMP Grade C wash room are also housed within the new facility. The modular cleanroom facility is linked to an existing building that accommodates an EU GMP Grade D preparation and final packaging area. A pressure plenum ceiling system with fan filter units runs through the five unit modular cleanroom facility and distributes the air into the cleanroom areas in the module and the existing building. A plant skid is mounted externally on the roof on top of the modules, housing the air handling unit and associated plant and is connected to the plenum system. The plant skid also houses the cooling, vacuum, extract and control systems for the modules and production equipment.

Transport to Site
Ferrosan’s modular cleanroom facility was designed and constructed in five modular adjoining hot-rolled frames, each measuring 10.3 by 4.9 ms wide and 4 meters high. Due to the size of the modules, Clean Modules works with specialist transport companies such as Abnormal Loads Services for the transport of the modules from Clean Modules’s premises to site.

The Ferrosan modules were delivered in Denmark by a combination of 3, 4 and 5 axle wafer deck low loaders with private escort cars. The modules were loaded and off-loaded by a 250-tonne mobile crane with a combination of 4 x spreader beams to ensure an evenly distributed 6-point lift

Compliance
The new cleanroom facility is compliant with EU GMP cleanroom standards and Danish and European building standards. Initial product trials have been completed successfully. Ferrosan will conduc further product trials over the next months and plans to launch its new product within a year. 

Jelle Hanse
Export Executive
Clean Modules Ltd
T: +44 1332 696970
export@cleanmodules.co.uk
www.cleanmodules.co.uk