The trends in clean room technology are changing at a rapid pace. Everything in the clean room right from equipment to garments is changing. Moreover due to the sky-rocketing prices, pharmaceutical companies have to think twice before building a clean room facility especially when their product are yet to be approved. To avoid this uncertainty of manufacturing of unapproved products, companies are now adopting modular concepts.
Modular clean room is the latest technogloy where steel sandwich insulated panels of different core material and cladding materials are used for room construction instead of cement-mortar construction which helps in time saving, power saving due to insulation of rooms and shifting of one unit to another depending upon viability and inter-shifting of cleanroom in same plant also, says an industry expert.
Clean room modular partitions are an ideal alternative to conventionally constructed civil walls; firstly because they do not shed any particles like civil walls, thus contributing less to airborne particulate matter and secondly they can be easily cleaned every day. Also the wall thickness of modular partition is less than that of a civil wall, thus providing more usable area for clean room applications, he pointed out.
Modular cleanrooms are more commonly used for larger cleanrooms inside a manufacturing space. These cleanrooms are flexible to long term expansion and moving large equipment through the removable wall panels. They also have the flexibility of utilizing a once thru or recirculating HVAC design. In addition, the variety of wall panel construction and surface material allows these systems to be practical in virtually any environment.
Modular, free-standing cleanrooms have many distinct advantages over their fixed wall counterparts. Using modular rooms greatly reduces design, engineering, and construction time, thereby reducing time, money and taxes. All material is pre-cut, metered and completely finished. No taping, sanding or painting are needed. Since they are not an integral part of a larger structure, modular rooms can be taken down and moved to other facilities, or even sold as an asset. Fixed wall cleanrooms do not have this flexibility.
Expanding a modular cleanroom can be easily accomplished by taking off a wall and adding another module. The prefabricated design allows the room to be expanded, relocated, or reconfigured into a different shape or made into multiple smaller rooms.
All air handling and filtration equipment modules are built into the modular room ceiling. Hook-ups for electrical and plumbing are engineered in as part of the design.
The amount of time it takes to construct a modular room is much less than constructing a permanent walled structure. It can take several months to construct a fixed wall cleanroom because of the amount of design, engineering, and the various trades involved. However, a fairly sophisticated modular room can be constructed in a week or two. On-site assembly of a modular cleanroom is also less disruptive to surrounding operations in comparison to their fixed wall counterparts.
There are two basic types of modular, solid wall cleanrooms: recirculating and non-recirculating. Product and process requirements will determine which type of room is best suited for a company’s needs.
Recirculating cleanrooms recirculate the air within the cleanroom and prevent it from mixing with the outside air, allowing for better control of the temperature and humidity. Air is recirculated back to the high efficiency particulate absorbing (HEPA) filters located in the cleanroom’s ceiling. This is accomplished by using air return chambers in the room’s walls or through existing walls of the building. The recirculating cleanrooms will have less contamination loading on the HEPA filters because the system is recycling previously cleaned air. With less contamination loading, the filters will last longer and preform better.
Non-recirculating, sometimes called single pass rooms, draw in air from above the room into the ceiling HEPA filters. The filtered air is then blown into the cleanroom and exits through an approximate two-inch space located below the walls or through adjustable wall grills. Non-recirculating cleanrooms are less costly to construct than recirculating rooms due to the lack of return air duct-work.
The modular cleanroom location within a building is very important. Physical space, temperature/humidity, and cleanliness will affect selection decisions and overall project cost.
Installation of a modular, hardwall cleanroom is quick and easy. With modular systems everything is prefabricated at the factory, so specialists are not needed to assemble the room, just local trades or internal people. It’s not uncommon to start a project on Monday and finish on Friday.
An example for this was the construction of a modular cleanroom facility in the United Kingdom and installation in Denmark. To reduce the time to market for its latest product line, Danish medical device manufacturer Ferrosan partnered with Clean Modules, a UK-based cleanroom company to have a 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.
Since 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.
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 that specialises in the design and construction of cleanrooms. 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. On-site 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.
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.
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. Thee new cleanroom facility is compliant with EU GMP cleanroom standards and Danish and European building standards.