Clean Modules has designed and constructed a modular cleanroom facility for Denmark-based Ferrosan, a consumer healthcare and medical devices company.
The 325m2 cleanroom facility, which was completed within a tight time schedule of 14 weeks, was pre-manufactured as a whole in the UK and shipped to Denmark and positioned on site, with final hook-up, finishing module connections and services, commissioning and validation being completed on site in Denmark.
In order to reduce the time to market, Ferrosan wanted to improve its construction methods to accommodate the latest product line.
Ferrosan conducted research into what construction method would best suit its budget, time restraints and user requirements.
The tight time restraints would not allow for the construction of a new building in the conventional way and renting existing facilities at an alternative site would add to the running costs of the facility.
As a result, Ferrosan opted to construct the new facility using alternative methods.
After further research, it teamed up with Clean Modules, a UK cleanroom company that specialises in the design and construction of cleanrooms, particularly using pre-built and modular construction.
The modular cleanroom solution is described as a quick and cost-efficient construction method for cleanroom projects without an existing shell building.
This construction method is based on the factory manufacture of the cleanrooms in modular sections, which are then shipped to the site, installed and commissioned.
Clean Modules' modular cleanrooms are constructed with System I cleanroom panels, composite panels and concrete board within a hot-rolled steel frame.
Onsite pad foundations need to be installed and services brought to the cleanroom perimeter.
The facility does not contain any timber and, unlike cleanrooms constructed within converted timber cabins, Clean Modules' modular cleanrooms are claimed to feel and behave in the same way as a rigid traditional building and with a similar durability.
A benefit of Clean Modules' modular cleanroom construction method is that the facility is constructed as a whole away from the site.
In the UK, Clean Modules constructed the 235m2 modular cleanroom facility, while in Denmark another Clean Modules site team prepared the foundations and converted an existing 90m2 in-situ laboratory into an EU GMP Grade D preparation area.
The two areas would later be linked together during the 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 UK.
All the equipment was installed and pre-commissioned away from the site.
The AHU only had to be connected to the modular cleanroom facility on site.
Other services were also installed off site with a plug-and-play system that was plugged in, re-tested and commissioned on site.
The ability to construct the facility at Clean Modules' premises, with all the design and construction facilities nearby, resulted in the more efficient use of time and reduced labour and specialist trade costs.
The new facility is said to be both flexible and versatile; to ensure that the manufacture of new products can develop with Ferrosan's demands, the facility will allow for future extensions with additional modules.
The hot-rolled frames simplify transport, provide the backbone of the facility and make modular cleanrooms feel like traditional rigid buildings, according to Clean Modules.
The steel frames also allow for a more flexible layout, enabling longer ceiling spans and the creation of rooms that are larger than the individual modules.
The modular cleanroom facility for Ferrosan houses a 160m EU GMP Grade C production hall that spreads through all five modules.
The production hall has a dedicated filling area with unidirectional air flow for filling the product into its primary packaging.
In addition, the production hall houses a secondary packaging area with two interconnected packaging systems totalling 17m in length.
An EU GMP Grade C product weighing and mixing room with a dedicated extract system and an EU GMP Grade C washroom 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 AHU 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.
Ferrosan's modular cleanroom facility is designed and constructed in five modular adjoining hot-rolled frames, each measuring 10.3m in length, 4.9m in width and 4m in height.
Owing 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 its premises to the site.
The Ferrosan modules were delivered in Denmark by a combination of three-, four- and five-axle wafer deck low loaders with private escort cars.
The modules were loaded and offloaded by a 250-tonne mobile crane with a combination of four spreader beams to ensure an evenly distributed six-point lift.
The facility is fully compliant with EU GMP cleanroom standards and Danish and European building standards.
Initial product trials have been completed successfully.
Ferrosan will be conducting further product trials over the next few months and plans to launch its new product within a year.
